Hungarian Act XCV of 2005

Act XCV of 2005 - on Medicinal Products for Human Use and on the Amendment of Netjogtár
Other Regulations Related to Medicinal Products

Hatály: 2021.XII.1. - határozatlan 1. oldal
Act XCV of 2005
on Medicinal Products for Human Use and on the Amendment of

Other Regulations Related to Medicinal Products1
The purpose of this Act is to set forth the fundamental regulations pertaining to
medicinal products, the supply of medicinal products and the rights of users of
medicinal products, in harmony with Community legislation and international
regulations and recommendations.
Responsibility for laying down provisions for the supply of medicinal products shall
lie with the State. As part of this duty, the State shall determine the set of
requirements necessary to ensure that persons in need of safe and effective
medicinal products, whose quality is in conformity with statutory requirements, shall
be able to obtain them on a regular basis.
As part of the State's responsibilities for the preservation and restoration of human
health, and guided by its responsibility for such,
in light of the fact that the essential aim of any rules governing the production,
distribution and use of medicinal products must be to safeguard public health, and
that the measures adopted within the framework of public policies concerning the
distribution and use of medicinal products are aimed to ensure any person in need
shall have access to sufficient medicinal products for treatment,
recognizing, however, that, characteristic of the market of medicinal products for
human use, the users of medicinal products or the patients have little influence at
this time on selecting the medicinal product that is right for them, and
in addition to the above, taking into consideration that this objective must be
attained by means which will not hinder the development of the pharmaceutical
industry or trade in medicinal products within the Community,
Parliament has adopted the following Act:
Section 1
For the purposes of this Act:
1)2 'medicinal product' shall mean any substance or combination of substances
presented for treating or preventing diseases in human beings or any substance or
combination of substances which may be used in, or directly applied to, the human
body, either with a view to restoring, correcting or modifying physiological functions
by exerting a pharmacological, immunological or metabolic action, or to making a
medical diagnosis;
2) 'magistral formula' shall mean any medicinal product prepared by a pharmacist
in a pharmacy in accordance with the instructions set out in the Hungarian or
European Pharmacopoeia (hereinafter referred to as "Pharmacopoeia") or in the
Catalogue of Standard Prescriptions (Fo-No) (hereinafter referred to as "Catalogue of
Prescriptions") in accordance with a doctor's prescription or upon his own initiative
in accordance with the prescriptions of the Pharmacopoeia and which is intended to
be supplied directly to the patients served by the pharmacy in question;
3) 'homeopathic medicinal product' shall mean any medicinal product prepared
from substances called homeopathic stocks made according to the homeopathic
manufacturing procedure described by the Pharmacopoeia in accordance with a
homeopathic manufacturing procedure described by the Pharmacopoeia; a
homeopathic medicinal product may contain a number of principles;
1 Promulgated on 15 July 2005.

2 Established: by paragraph (1) Section 100 of Act CXXVII of 2013. In force: as of 6. 07. 2013.
4)1 'narcotic drug' shall mean the substances listed in Annex I and II of the
Schedule to Law-Decree No. 4 of 1965 promulgating the Single Convention on
Narcotic Drugs done at New York on 30 March 1961;
4/a)2 'medicinal product classified as a narcotic drug' shall mean any medicinal
product that contains any active substance that is classified as narcotic and listed in
Annex I and II of the Schedule to Law-Decree No. 4 of 1965 promulgating the Single
Convention on Narcotic Drugs done at New York on 30 March 1961;
5)3 ‘psychotropic substance’ shall mean the substances listed in Annexes I-IV of
Law-Decree No. 25 of 1979 promulgating the Convention on Psychotropic Substances
done at Vienna on 21 February 1971, as well as the substances listed in appendices
of Annex 2;
5/a)4 ‘medicinal product classified as a psychotropic substance’ shall mean any
medicinal product that contains any active substance that is classified as a
psychotropic substance and listed in Annexes II-IV of Law-Decree No. 25 of 1979
promulgating the Convention on Psychotropic Substances done at Vienna on 21
February 1971, as well as the substances listed in Appendix B) of Annex 2;
6)5 'investigational medicinal product' shall mean a pharmaceutical form of an
active substance or placebo being tested or used as a reference in a clinical trial,
including products that already have a marketing authorization but are used or
assembled (formulated or packaged) in clinical trials in a way different from the
authorized form, or when used for an unauthorized indication, or when used to gain
further information about the authorized form of the medicinal product in question;
7) 'clinical trial' shall mean any investigation in human subjects conducted at a
single site or according to a single protocol but at more than one site:
a) intended to discover or verify the clinical, pharmacological and/or other
pharmacodynamic effects of one or more investigational medicinal product(s), and/or,
b) to identify any adverse reactions to one or more investigational medicinal
product(s) and/or,
c) to study absorption, distribution, metabolism and excretion of one or more
investigational medicinal product(s) with the object of ascertaining its (their) safety
and/or efficacy, and the risk-benefit balance,
not including non-interventional trials;
8) 'non-interventional trial' shall mean a study:
a) where the medicinal product(s) with a marketing authorization is (are)
prescribed not for the trial;
b) where the medicinal product(s) is (are) prescribed in the usual manner in
accordance with the terms of the marketing authorization;
c) where the assignment of the patient to a particular therapeutic strategy is not
decided in advance by a trial protocol but falls within current practice and the
prescription of the medicine is clearly separated from the decision to include the
patient in the study;
d) where no additional diagnostic or monitoring procedures are applied to the
patients; and
e) where only epidemiological methods are used for the analysis of collected data;
9) 'marketing authorization holder' shall mean a natural or legal person or
unincorporated organization, to whom the competent authority has granted
authorization for the marketing of a specific medicinal product;
1 Established: by paragraph (1) Section 73 of Act CLIV of 2009. In force: as of 1. 01. 2010.
2 Enacted on the base: of paragraph (1) Section 73 of Act CLIV of 2009. In force: as of 1. 01. 2010.
3 Established by Subsection (1) of Section 178 of Act LXVII of 2016, effective as of 17 July 2016.
5 Established: by Section 20 of Act XXVIII of 2008. In force: as of 01. 07. 2008.
10)1 'representative of the marketing authorization holder' shall mean a natural or

legal person or unincorporated organization designated by the marketing
authorization holder to represent him in the territory of Hungary in the cases
specified by the marketing authorization holder;
11) 'manufacture of medicinal products' shall mean the authorized production of
medicinal products in a controlled industrial environment;
12) 'production batch' shall mean a specific quantity of starting materials,
packaging materials or products produced during a continuous manufacturing
process or a defined cycle of manufacture in such a way that it could be expected to
be of a uniform character and should be designated as such;
13) 'name of the medicinal product' shall mean the name given to a medicinal
product as indicated in the marketing authorization, which may be either an invented
name (which shall not be liable to be confused with the common name used), or a
common or scientific name, together with a trade mark or the name of the marketing
authorization holder;
14) 'international non-proprietary name' shall mean the common name
recommended by the World Health Organization, or, if one does not exist, the usual
common name used;
15) 'classification of a medicinal product' shall mean the category of a medicinal
product that is indicated in the marketing authorization, or in connection with
magistral formulas in the Pharmacopoeia or the Catalogue of Prescriptions, declaring
it a prescription or non-prescription medicinal product;
16) 'non-prescription medicinal product' shall mean all medicinal products qualified
as such by the licensing authority in the marketing authorization, or in the case of
magistral formulas, which are qualified as such in the Pharmacopoeia or the
Catalogue of Prescriptions;
17) 'summary of product characteristics' shall mean a guide contained in the
marketing authorization and addressed to doctors and pharmacists, containing the
particulars, dosage and administration and characteristics of the medicinal product in
question;
18) 'package leaflet' shall mean a leaflet containing information for the user
(patient) in a comprehensible manner according to this Act, which accompanies the
medicinal product;
19) 'immediate packaging' shall mean the container or other form of packaging
immediately in contact with the medicinal product;
20) 'outer packaging' shall mean the packaging into which is placed the immediate
packaging;
21)2 ‘Pharmacopoeia’ shall mean the official publication, published and amended by
the government body for pharmaceuticals for mandatory use by the manufacturers
and distributors of medicinal products and for doctors and pharmacists, containing
the general rules for the manufacture of medicinal products, the quality of medicinal
products and pharmaceutical ingredients, the control of medicinal products and the
classification of medicinal products, and the quality norms and composition of certain
medicinal products;
22)3 ‘Standard Catalogue of Prescriptions (Fo-No)’ shall mean the official
publication, published and amended by the government body for pharmaceuticals for
mandatory use by the manufacturers and distributors of medicinal products and for
doctors and pharmacists, containing regulations for the preparation of magistral
formulas, and the quality norms and composition of certain medicinal products;
23)4 ‘patient care interests deserving special consideration’ shall refer to the
situation when a medicinal product which does not have a valid marketing
authorization in Hungary offers the potential of successful treatment, and
1 Amended: by subparagraph a) Section 95 of Act CLXXVI of 2011. In force: as of 1. 01. 2012.

2 Established: by paragraph (1) Section 43 of Act CLXXIII of 2010. In force: as of 1. 01. 2011.
4 Established by Section 237 of Act XCIX of 2021, effective as of 1 December 2021.
a) no other medicinal product marketed in Hungary at the time has the capacity
of providing such treatment,
b) other medicinal products with the potential of successful treatment, which are
already placed on the market in Hungary or in any EEA Member State is not available
in Hungary in sufficient quantities, or
c) access to a medicinal product with marketing authorization for a specific
indication is inhibited to an extent where it would likely to delay the treatment
prescribed for the patient, hence causing disproportionately great risk of irreversible
health impairment;
24) 'European Medicines Agency' shall mean the European Medicines Agency
established under Regulation (EC) No. 726/2004 of the European Parliament and of
the Council laying down Community procedures for the authorization and supervision
of medicinal products for human and veterinary use and establishing a European
Medicines Agency;
25) 'risks related to use of the medicinal product' shall mean any risk relating to the
quality, safety or efficacy of the medicinal product as regards patients' health or
public health, and any potential risks presented by the medicinal product for the
environment;
26) 'risk-benefit balance' shall mean an evaluation of the positive therapeutic
effects of the medicinal product in relation to the risks as defined in Point 25;
27)1 'post-authorization safety study' shall mean all studies conducted in connection
with medicinal products with marketing authorization with the aim of identifying,
characterizing or quantifying a safety hazard, confirming the safety profile of the
medicinal product, or of measuring the effectiveness of risk management measures;
28)2
29)3 'advanced therapy (novel) medicinal product' shall mean any of the medicinal
products shown in Article 2 (1) a) of Regulation (EC) No. 1394/2007 of the European
Parliament and of the Council of 13 November 2007 on advanced therapy medicinal
products and amending Directive 2001/83/EC and Regulation (EC) No. 726/2004.
30)4 'pharmacovigilance' shall mean the activities designed to monitor the safety of
authorized medicinal products and detect any change to their risk-benefit balance,
aiming to reduce the risks of, and increase the benefits from, such medicinal
products;
31)5 'Pharmacovigilance Risk Assessment Committee' shall mean the scientific
committee of the European Medicines Agency;
32)6 'risk management system' shall mean a set of pharmacovigilance activities and
interventions designed to identify, characterize, prevent or minimize risks relating to
a medicinal product, including the assessment of the effectiveness of those activities
and interventions;
33)7 'risk management plan' shall mean a detailed description of the risk
management system;
34)8 'pharmacovigilance system' shall mean a system used to fulfil
pharmacovigilance tasks and responsibilities and designed to monitor the safety of
authorized medicinal products and detect any change to their risk-benefit balance;
35)9 'pharmacovigilance system master file' shall mean a detailed description of the
pharmacovigilance system used by the marketing authorization holder with respect to
one or more authorized medicinal products;
1 Established: by paragraph (2) Section 79 of Act CLXXVI of 2011. In force: as of 21. 07. 2012.
2 Repealed: by subparagraph a) paragraph (5) Section 83 of Act XCVIII of 2006. No longer in force:
as of 01. 01. 2007.
4 Enacted: by paragraph (3) Section 79 of Act CLXXVI of 2011. In force: as of 21. 07. 2012.
36)1 'coordination group' shall mean the body referred to in Article 27 of Directive
2001/83/EC of the European Parliament and of the Council of 6 November 2001 on
the Community code relating to medicinal products for human use;
37)2 ‘new psychoactive substance’ shall mean a new substance or compound never
before used in the field of medicine that, acting on the central nervous system,
functions as a mood altering drug, having the capacity to change human behavior and
perception, and that may consequently pose a comparable threat to public health as
the substances listed in Tables I and II of the Single Convention on Narcotic Drugs
signed in New York on 30 March 1961, promulgated by Law-Decree No. 4 of 1965, or
in Lists I and II of the Annex to the Convention on Psychotropic Substances signed in
Vienna on 21 February 1971, promulgated by Law-Decree No. 25 of 1979, or in the
lists of psychotropic substances contained in Annex 2, and that has been classified on
that basis as a psychoactive substance by the minister in charge of the healthcare
system by means of a decree;
38)3 'active substance' shall mean any substance or mixture of substances intended
to be used in the manufacture of a medicinal product and that, when used in its
production, becomes an active ingredient of that product intended to exert a
pharmacological, immunological or metabolic action with a view to restoring,
correcting or modifying physiological functions or to make a medical diagnosis;
39)4 'excipient' shall mean any constituent of a medicinal product other than the
active substance and the packaging material;
40)5 'brokering of medicinal products' shall mean all activities in relation to the sale
or purchase of medicinal products, except for wholesale distribution, that do not
include the physical handling of medicinal products and that consist of negotiating
independently and on behalf of another legal or natural person;
41)6 'broker of medicinal products' shall mean any natural or legal person engaged
in the pursuit of brokering of medicinal products.
42)7 'falsified medicinal product' shall mean any medicinal product with unverified
origin or with a false representation - excluding unintentional quality defects - of:
a) its identity, including its packaging and labeling, its name or its composition as
regards any of the ingredients including excipients and the strength of those
ingredients,
b) its source, including its manufacturer, its country of manufacturing, its country
of origin or its marketing authorization holder,
c) its history, including the records and documents relating to the distribution
channels used,
without prejudice to infringements of intellectual property rights.
43)8 'parallel import' shall mean the importation into Hungary of a version of a
medicinal product for human use authorized for placing on the market which meets
the conditions set out in the ministerial decree on the pursuit of the business of
wholesale distribution and parallel importation of medicinal products, from any
States which are parties to the EEA Agreement where the medicinal product has
already received a marketing authorization.
44)9 'recall' shall mean any measure aimed at achieving the return of a medicinal
product that has already been made available to the end user or that is found at
distributors;
3 Enacted: by Section 52 of Act LXXIX of 2012. In force: as of 2. 01. 2013.
7 Enacted by Subsection (2) of Section 74 of Act CCXII of 2012. Amended by Point 1 of Section 109
of Act CI of 2021.
8 Enacted: by paragraph (2) Section 74 of Act CCXII of 2012. In force: as of 2. 01. 2013.
9 Enacted: by paragraph (2) Section 100 of Act CXXVII of 2013. In force: as of 6. 07. 2013.
45)1 'withdrawal from the market' shall mean any measure aimed at preventing a
product in the supply chain from being made available on the market;
46)2 ‘economic operator’ shall have the same meaning as defined in the Code of
Civil Procedure.
47)3 ‘patient care requirement’ shall mean actual need relating to the use of a
specific medicinal product, effecting patients in Hungary;
48)4 ‘State aid’ shall mean aid provided under the Government Decree on
Proceedings Related to State Aid Within the Meaning of European Union Competition
Law and on the Regional Aid Map (hereinafter referred to as “Aid Decree”);
49)5 ‘single undertaking’ shall mean the enterprises referred to in Article 2(2) of
Commission Regulation (EU) No. 1407/2013 of 18 December 2013 on the application
of Articles 107 and 108 of the Treaty on the Functioning of the European Union to de
minimis aid (hereinafter referred to as “Commission Regulation 1407/2013/EU”);
50)6 ‘aid intensity’ shall have the meaning provided for in the Aid Decree;
51)7 ‘grant equivalent’ shall have the meaning provided for in the Aid Decree.
52)8 ‘continuous supply’ shall mean supplies provided on an ongoing basis to satisfy
the orders of wholesalers of medicinal products under contract with the holders of
marketing authorizations or - if they are not engaged in any distribution activities in
Hungary - with the distributors;
53)9 ‘ex tempore radiopharmaceutical product’ shall mean a medicinal product
manufactured in accordance with Chapter 5.19 Ex Tempore Radiopharmaceutical
Products of the Pharmacopœia by a healthcare service provider that uses a
radiopharmaceutical product prescribed by a treating doctor for a specific patient
that does not have marketing authorization in Hungary, or by a pharmaceutical
producer authorized to produce radiopharmaceutical products.
Scope
Section 2
(1)10 The provisions of this Act shall apply to the manufacture, production,
placing on the market, distribution and use of medicinal products for human use, and
to the clinical trial and use of investigational medicinal products.
(2) Where there is any doubt in connection with a product - taking into
consideration of what is contained in Subsection (1) - to which the definition set out
in Point 1 of Section 1 applies, and that may be subject to the definition of another
product contained in another piece of legislation as well, the provisions of this Act
shall prevail.
(3)11 This Act shall not apply to whole blood, plasma or blood cells of human origin,
except for plasma which is prepared by a method involving an industrial process, nor
to medical devices, food preparations, dietary supplements, cosmetics, and other
products intended for human use, governed by other legislation, as well as
disinfectants not used in or on the human body, and medical laboratory diagnostic
agents.
2 Enacted by Subsection (1) of Section 10 of Act CCLII of 2013, effective as of 15 March 2014.
3 Enacted by Section 51 of Act LXXVII of 2015, effective as of 1 July 2015.
4 Enacted by Section 24 of Act LIX of 2017, effective as of 1 July 2017.
8 Enacted by Subsection (1) of Section 13 of Act CLXXXVIII of 2017, effective as of 1 January 2018.
10 Amended: by subparagraph a) paragraph (5) Section 83 of Act XCVIII of 2006. In force: as of 01.
01. 2007.
11 Established: by Section 53 of Act LXXIX of 2012. In force: as of 1. 07. 2012.
Clinical Trial
Section 3
(1) Concerning the authorization and conduct of clinical trials the provisions of
the Health Care Act pertaining to medical research in human subjects shall apply
subject to the exceptions set out in this Act.
(2)1 The authorization of the government body for pharmaceuticals - issued on the
basis of the opinion of the competent research ethics committee of the Medical
Research Council - shall be required for the clinical trial of any investigational
medicinal product in the territory of Hungary.
(3)2 The clinical trial of any investigational medicinal product in the territory of
Hungary shall not be subject to the special authority’s prior express consent.
(4)3 The administrative time limit for the authorization of clinical trials shall be
seventy-five days; within such period the ethics assessment shall be completed within
sixty days. The administrative time limit for clinical trials involving investigational
medicinal products for gene therapy and somatic cell therapy or medicinal products
containing genetically modified organisms shall be ninety days from the date of
submission of the application; within such period the ethics assessment shall be
completed within not more than seventy-two days. The administrative time limit for
clinical trials involving investigational medicinal products for xenogenic cell therapy
shall be twelve months from the date of submission of the application; within such
period the ethics approval shall be completed within not more than eleven months.
(5)4 The sponsor of a clinical trial shall obtain sufficient liability insurance cover
for any damage, or for restitution payable in connection with any violation of rights
relating to personality that may occur in connection with a clinical trial, from an
insurance company that is established or has a branch in any Member State of the
European Economic Area (hereinafter referred to as “EEA”), or in any State enjoying
equal treatment with EEA Member States by virtue of an international agreement
with the European Communities or with the EEA (hereinafter referred to as “States
which are parties to the EEA-Agreement”). The liability insurance policy shall afford
sufficient cover for any and all potential claims for damage and restitution in
connection with the clinical trial.
(6)5 Commencement of authorized clinical trials shall be notified to the
government body for pharmaceuticals.
(7)6 Decisions adopted in authorization, amendment and control procedures
relating to clinical trials, medicinal products, narcotic drugs, psychotropic
substances, investigational medicinal products may not be overturned by the court in
an administrative action.
(8)7 The sponsor of the clinical trial shall enter into an agreement in writing for
the conduct of the clinical trial with the medical service provider conducting it, or
with the leader of the clinical trial. The agreement shall be deemed valid only on the
basis of the consent of the government body for pharmaceuticals granted on the basis
of the opinion of the competent research ethics committee of the Medical Research
Council.
1 Established by Subsection (1) of Section 254 of Act L of 2017, effective as of 1 January 2018.
4 Established by Subsection (2) of Section 10 of Act CCLII of 2013, effective as of 15 March 2014.
5 Amended: by subparagraph c) paragraph (2) Section 106 of Act CIX of 2006. In force: as of 01. 01.
2007.
(9)1 If the protocol is modified after the authorization of the clinical trial becomes
definitive, the committee of the Medical Research Council shall make its opinion
known on the application for modification within thirty days from the date of receipt
thereof. If the modification is substantial and it can be decided without the specialist
authority’s assessment, or it concerns the quality of medicinal products, authorization
shall be decided by the competent body within its sphere of competence, without
consulting the specialist authority.
Provisions for the Manufacture of Medicinal Products
Section 4
(1)2 With the exception of magistral formulas produced in pharmacies, medicinal
products may only be produced in the territory of Hungary in possession the
authorization of the government body for pharmaceuticals granted for this specific
purpose. The organization holding a license for the manufacture of a medicinal
product shall be construed as the manufacturer of that medicinal product.
(2)3 The government body for pharmaceuticals shall authorize the production of a
medicinal product if the applicant is able to satisfy the personnel and infrastructure
requirements set out in specific other legislation to ensure that the quality of the
medicinal products manufactured will be in conformity with the requirements laid
down in the marketing authorization. An authorization for the manufacture of a
medicinal product shall also constitute entitlement for trading the manufacturer's
own products on the wholesale market, on condition that the manufacturer is able to
comply in its wholesale distribution operations with the personnel and infrastructure
requirements set out in specific other legislation for the wholesale distribution of
medicinal products.
(3) Another precondition for the authorization referred to in Subsection (1) is for
the applicant to have liability insurance coverage for any potential claims for
damages in connection the technological processes in the manufacture of medicinal
products.
(4)4 Applications for authorization shall be submitted to the government body for
pharmaceuticals on the standard forms containing the information decreed by the
competent minister.
(5)5 The government body for pharmaceuticals shall inspect the production site and
shall check to ascertain as to whether the applicant is able to comply with the
personnel and infrastructure requirements prescribed in specific other legislation for
the manufacture of medicinal products, and has sufficient facilities for documentation
and quality assurance.
(6)6 The government body for pharmaceuticals shall adopt a decision concerning
the application within ninety days.
1 Enacted by Subsection (1) of Section 112 of Act CLXXXVI of 2015. Amended by Paragraph a) of
Section 255 of Act L of 2017.
2 Amended: by subparagraph b) paragraph (2) Section 106, subparagraph g) Section 108 of Act CIX
of 2006. In force: as of 01. 01. 2007. Amended: by subparagraph d) Section 95 of Act CLXXVI of
2011. In force: as of 1. 01. 2012.
3 Amended: by subparagraph b) paragraph (2) Section 106 of Act CIX of 2006. In force: as of 01. 01.
2007.
2007. Amended: by Section 328 of Act LVI of 2009. In force: as of 1. 10. 2009.
6 Established: by Section 75 of Act CCXII of 2012. In force: as of 2. 01. 2013.
(6a)1 If based on the findings of an inspection of any manufacturing site of

medicinal products, or of active substances and excipients used as starting materials
for the manufacture of medicinal products, or the facilities of wholesalers of
medicinal products, carried out by way of sampling and analysis or the inspection of
the related documents it is determined that the inspected entity does not comply with
the legal requirements and/or the principles and guidelines of good manufacturing
practice or good distribution practices as provided for by Union law, the government
body for pharmaceuticals shall take the measures necessary and shall send its
findings to the European Medicines Agency.
(7)2 Any person engaged in the manufacture of medicinal products classified as
narcotic and psychotropic substances and medicinal products containing any active
substance falling under the scope of the legislation on regulatory procedures relating
to drug precursors and laying down provisions concerning the powers and
responsibilities of public authorities must have a separate authorization for that
particular purpose.
(8) The authorized manufacturer of medicinal products shall make arrangements:
a) in connection with the medicinal products produced:
aa) for quality control or certification of quality, and for a computerized system in
connection with the certification of quality;
ab) for setting up a laboratory in compliance with the requirements set out in
specific other legislation for reasons of quality assurance;
ac) for the withdrawal from circulation and for their seizure;
b) for keeping the records prescribed in specific other legislation and for retaining
at least two complete factory package units from each production batch for the
purposes of investigation for the period of the proposed shelf life indicated, plus one
year;
c) for notification of the authority issuing the marketing authorization concerning
any medicinal product deemed defective, indicating the defect and the serial number;
d) for the withdrawal from the market of any medicinal products it has produced
and placed on the market and for notifying the authority issuing the marketing
authorization concerning the nature of the defect;
e) for collecting the complete batch of the medicinal products that were withdrawn
from the market from the buyers to whom they were delivered;
f) for the destruction of defective products and documentation of the process;
g) for drawing up warehousing procedures.
(9) All products shipped to the buyer from the warehouse shall be accompanied by a
quality certificate. The factory packaging of products delivered shall have affixed the
manufacturer's corporate logo to permit identification of the products' place of origin
subsequently.
(10)3 Authorized manufacturers of medicinal products shall notify the government
body for pharmaceuticals of the suspension of their operations of manufacture of
medicinal products for any period over six months, indicating the proposed duration
of suspension, at least three months before the scheduled date of suspension.
(11)4 Authorized manufacturers of medicinal products shall notify the government
body for pharmaceuticals without delay concerning any changes in their particulars
listed under Subsection (2). The government body for pharmaceuticals shall adopt a
decision concerning the amendment of the authorization under Subsection (1)
according to the changes notified within thirty days.
1 Established: by Section 15 of Act XL of 2013. In force: as of 29. 04. 2013.

2 Established: by Section 74 of Act CLIV of 2009. In force: as of 1. 01. 2010.
2007.
4 Amended by paragraph (4) Section 83 of Act XCVIII of 2006, subparagraphs b)-c) paragraph (2)
Section 106 of Act CIX of 2006, Sections 328-329 of Act LVI of 2009, Paragraph a) of Section 113
of Act CLXXXVI of 2015.
(12) At the request of a manufacturer of medicinal products, the government body

for pharmaceuticals shall issue an official certificate based on the report drawn up on
the inspection of production. The official certificate shall contain:1
a) the manufacturer's particulars (name, address);
b) if the inspection pertains to the production of a specific medicinal product or
pharmaceutical form, the identification data of these;
c) the date and time of the inspection;
d) the date of the certificate; and
e) the findings of the inspection.
(13)2
Section 4/A3
(1)4 The authorization of the government body for pharmaceuticals for the
manufacture of medicinal products (hereinafter referred to as “authorization for the
manufacture of medicinal products”) is required for the importation of medicinal
products from outside the EEA, or from any State enjoying equal treatment with
States which are parties to the EEA-Agreement by virtue of an agreement with the
European Communities or with the European Union (hereinafter referred to as “third
country”), or for the manufacture of such products for export only.
(2)5 No authorization is required for the procurement of medicinal products if such
medicinal products are required for research purposes, not including medical
research in human subjects, and the buyer notified the government body for
pharmaceuticals thereof, as decreed by the minister in charge of the healthcare
system. Any medicinal product procured under this Subsection for the purpose of
research may not be used for other purposes. Any medicinal product not used for
research purposes shall be destroyed. Upon the completion of research activities the
government body for pharmaceuticals shall be notified without delay.
(3)6 An authorization for the manufacture of medicinal products is not required for
medicinal products imported by a wholesaler of medicinal products authorized for the
wholesale distribution of medicinal products.
Authorization for the Marketing of Medicinal Products
Section 5
(1)7 Marketing authorization is the official resolution issued by the authority of
competence and jurisdiction permitting a medicinal product to be administered to
humans for therapeutic purposes. Unless this Act contains provisions to the contrary,
a medicinal product - not including magistral formulas - may be placed on the market
only if authorized by the government body for pharmaceuticals or by the European
Commission in accordance with Regulation (EC) No. 726/2004 of the European
Parliament and of the Council, Regulation (EC) No. 1901/2006 of the European
Parliament and of the Council or Regulation (EC) No. 1394/2007 of the European
Parliament and of the Council.
2007.
2 Repealed: by subparagraph b) paragraph (5) Section 51 of Act CIX of 2009. No longer in force: as
of 1. 01. 2010.
3 Established: by Section 81 of Act CLXXVI of 2011. In force: as of 1. 01. 2012.
4 Amended: by subparagraphs a) and b) Section 88 of Act CCXII of 2012. In force: as of 1. 01. 2013.
5 Established by Section 25 of Act LIX of 2017, effective as of 1 July 2017.
6 Enacted by Section 54 of Act CCXLIV of 2013, effective as of 1 January 2014.
7 Established: by Section 21 of Act XXVIII of 2008. In force: as of 01. 07. 2008. Amended: by Section
328 of Act LVI of 2009. In force: as of 1. 10. 2009.
(2) The government body for pharmaceuticals shall grant a marketing authorization
for a medicinal product if:1
a) the qualitative and quantitative particulars of the constituents are known and
declared, including the manufacturing process; and
b) its therapeutic efficacy has been clinically substantiated, except for homeopathic
medicinal products for which the simplified registration procedure is authorized; and
c) the risk-benefit balance is favourable.
(2a)2 Where so justified by safety concerns concerning a medicinal product, the
government body for pharmaceuticals may render marketing authorization for such
medicinal product conditional upon compliance with one or more of the following
requirements within the prescribed deadlines:
a) to take certain measures for ensuring the safe use of the medicinal product to be
included in the risk management system;
b) to conduct post-authorization safety studies;
c) to comply with obligations on the recording or reporting of suspected adverse
reactions which are stricter than those referred to in specific other legislation;
d) any other conditions or restrictions with regard to the safe and effective use of
the medicinal product;
e) the existence of an adequate pharmacovigilance system;
f) to conduct post-authorization efficacy studies taking into account the scientific
guidance published by the European Medicines Agency where concerns relating to
some aspects of the efficacy of the medicinal product are identified and can be
resolved only after the medicinal product has been marketed.
(3) In proceedings for the granting of marketing authorizations the government
body for pharmaceuticals shall accept the findings of investigations conducted in
States other than those which are parties to the EEA-Agreement if:3
a) it is prescribed by law or international agreement; or
b)4 it is satisfied that the method of execution and control of tests conducted in any
State that is not a party to the EEA-Agreement is in compliance with requirements set
out in Hungary.
(4)5 The government body for pharmaceuticals shall refuse to grant a marketing
authorization if the information that is to be conveyed in a comprehensible manner
according to this Act on the immediate or outer packaging (hereinafter referred to as
"label") or if the package leaflet is not in compliance with the requirements set out in
this Act and in specific other legislation pertaining to labelling and to the package
leaflet, or it is not consistent with the summary of product characteristics.
(5) The marketing authorization, in addition to the medicinal product's
identification data, shall contain:6
a) the number of the marketing authorization, the name of the marketing
authorization holder and the manufacturer's address;
b) the summary of product characteristics;
c) the label information;
d) the package leaflet;
e) the classification of the medicinal product;
f) the expected shelf life of the medicinal product and storage instructions.
2007.
2007.
4 Amended: by subparagraph e) Section 95 of Act CLXXVI of 2011. In force: as of 1. 01. 2012.
2007.
(6)1 The administrative time limit for marketing authorization procedures is two
hundred and ten days from the day following the date of submission of the
application. Marketing authorization may be granted only if the applicant is
established in any State that is a party to the EEA-Agreement. The marketing
authorization holder shall be responsible for marketing the medicinal product. The
designation of a representative shall not relieve the marketing authorization holder of
his legal responsibility concerning the product.
(7)2 The marketing authorizations issued under Subsections (1)-(6) shall remain in
effect for five years. The authorization may be renewed upon request, if submitted at
least nine months before the expiry of the prescribed period of validity and subject to
reassessment of the risk-benefit balance. The government body for pharmaceuticals
shall decide relating the renewal request within ninety days. Once renewed, the
marketing authorization shall be valid for an unlimited period, unless the government
body for pharmaceuticals decides, on justified grounds relating to pharmacovigilance
under this Subsection, including exposure of an insufficient number of patients to the
medicinal product concerned, to proceed with one additional five-year renewal only.
(8)3
(9)4 The marketing authorization holder shall notify any change in the person of the
manufacturer of the medicinal product or in the person of the marketing
authorization holder to the government body for pharmaceuticals within thirty days
following the effective date of the change in question.
(10)5 Applications for any amendments concerning the products for which the
government body for pharmaceuticals has granted authorization by means other than
the procedures specified in a binding legislation of the European Union shall be
assessed in accordance with the procedure laid down by Commission Regulation (EC)
No. 1234/2008.
Section 6
(1)6 The government body for pharmaceuticals, under patient care interests
deserving special consideration, may - ex officio - authorize the marketing of a
medicinal product that has been authorized for marketing in any State that is a party
to the EEA-Agreement.
(2)7 In connection with the authorization of a medicinal product for marketing in
accordance with Subsection (1) hereof, prior to granting the authorization the
government body for pharmaceuticals:
a) shall notify the marketing authorization holder in the State that is a party to the
EEA Agreement where the medicinal product in question has been authorized,
concerning its intention to grant a marketing authorization for the product by virtue
of this Act; and
b) shall request the competent authority of that State to supply a copy of the
assessment report prepared in accordance with specific other legislation for the
medicinal product in question and a copy of the marketing authorization of the
medicinal product.
1 Amended: by subparagraph a) Section 55 of Act CLXXIII of 2010. In force: as of 1. 01. 2011.

2 Established by Section 25 of Act CLXXII of 2016, effective as of 1 January 2017.
3 Repealed: by subparagraph c) paragraph (5) Section 51 of Act CIX of 2009. No longer in force: as
of 1. 01. 2010.
2007.
5 Enacted: by Section 45 of Act CLXXIII of 2010. In force: as of 1. 01. 2011.
(3)1 Upon receipt of a request specified in Paragraph b) of Subsection (2) hereof

from a State that is a party to the EEA Agreement, the government body for
pharmaceuticals shall satisfy the request within seventy-five days of the date of
receipt and shall send a copy of the assessment report and of the marketing
authorization of the medicinal product in question.
Provisional and Special Marketing
Section 7
(1)2 At the manufacturer's request and if justified by patient care interests
deserving special consideration, the government body for pharmaceuticals may grant
a provisional marketing authorization, before all trials are completed in full, for a
product that is deemed to be of appropriate quality based on the assessment already
completed and where the risk-benefit balance is considered to be favourable for
therapeutic value, for a maximum period of one year. The government body for
pharmaceuticals shall lay down in the provisional marketing authorization the
reporting requirements for the marketing authorization holder pertaining, in
particular, to the safety of the product. The conditions set out by the government
body for pharmaceuticals shall be reported at the times prescribed in the
authorization to the government body for pharmaceuticals.
(2)3 The government body for pharmaceuticals may temporarily authorize access to
and the application of an unauthorized medicinal product for the period referred to in
Subsection (1) in response to the suspected or confirmed spread of pathogenic
agents, toxins, chemical agents or nuclear radiation any of which could cause harm
and hence may present a substantial risk to public health.
(3)4 Upon request and in justified cases deserving special consideration, the
government body for pharmaceuticals may grant a special marketing authorization
for the distribution of an unauthorized medicinal product that meets the criteria set
out in Paragraph a) of Subsection (2) of Section 5, however, the requirements set out
in Paragraphs b) and c) are merely suspected and cannot be confirmed since the
number of patients involved in the clinical trial of the product is insufficient due to
the rarity of the disease. The government body for pharmaceuticals shall lay down in
the special marketing authorization the reporting requirements for the marketing
authorization holder pertaining, in particular, to the safety of the product. The
conditions set out by the government body for pharmaceuticals shall be reported at
the times prescribed in the authorization to the government body for
pharmaceuticals.
(4)5 The government body for pharmaceuticals shall assess compliance with the
requirements set out in Subsections (1)-(3) at least once a year. At the manufacturer's
request the government body for pharmaceuticals may extend the time limit specified
in the provisional marketing authorization to maximum one year.
Obligation to Conduct Post-Authorization Studies6
1 Enacted by Subsection (2) of Section 83 of Act CLXXVI of 2011. Amended by Point 4 of Section
109 of Act CI of 2021.
2 Amended: by subparagraphs b)-c) paragraph (2) Section 106 of Act CIX of 2006. In force: as of 01.
01. 2007.
3 Amended by subparagraph b) paragraph (2) Section 106 of Act CIX of 2006, Paragraph b) of
Section 61 of Act CCXLIV of 2013.
4 Amended: by subparagraphs b)-c) paragraph (2) Section 106 of Act CIX of 2006. In force: as of 01.
01. 2007.
2007.
6 Enacted: by Section 84 of Act CLXXVI of 2011. In force: as of 21. 07. 2012.
Section 7/A1
(1)2 After the granting of a marketing authorization, the government body for
pharmaceuticals may impose an obligation on the marketing authorization holder to
conduct a post-authorization safety study if there are concerns about the risks of an
authorized medicinal product, where so justified by new, or previously
underestimated, hazards. If the same concerns apply to more than one medicinal
product, the government body for pharmaceuticals shall, following consultation with
the Pharmacovigilance Risk Assessment Committee, encourage the marketing
authorization holders concerned to conduct a joint post-authorization safety study.
(2)3 Efficacy studies to be conducted in the cases provided for in Commission
Delegated Regulation (EU) No. 357/2014 of 3 February 2014 supplementing Directive
2001/83/EC of the European Parliament and of the Council and Regulation (EC) No.
726/2004 of the European Parliament and of the Council as regards situations in
which post-authorization efficacy studies may be required shall be ordered by the
(3) In the application of Subsections (1) and (2) hereof, the government body for
pharmaceuticals shall notify in writing:
a) the reasons for imposing the obligation;
b) the objectives for conduct of the study;
c) the timeframe for submission of the findings of the study; and
d) an indication that the marketing authorization holder is provided with an
opportunity to present written observations in response to the imposition of the
obligation within thirty days of receipt of the written notification.
(4) The government body for pharmaceuticals, if deemed necessary on the basis of
the written observations submitted according to Paragraph d) of Subsection (3), shall
impose the obligation to conduct the study under Subsection (1) or (2) hereof, and
shall amend the marketing authorization to include said obligation as a condition of
the marketing authorization.
(5) The holder of the marketing authorization shall update the risk management
system according to the resolution.
Updating the Risk Management System4
Section 7/B5
The holder of the marketing authorization shall update the risk management system
to include the activities prescribed by the government body for pharmaceuticals
under Subsection (2a) of Section 5, Section 7 and Section 7/A.
Labelling and Package Leaflet
Section 86
Unless otherwise prescribed in this Act, the outer packaging of medicinal products,
if any, and the immediate packaging shall have affixed the information prescribed in
specific other legislation.

2 Established: by Section 57 of Act LXXIX of 2012. In force: as of 22. 07. 2012.
3 Established by Section 52 of Act LXXVII of 2015, effective as of 1 July 2015.
6 Established: by Section 67 of Act CVI of 2008. In force: as of 01. 01. 2009.
Section 9
A package leaflet must be inserted in the packaging of all medicinal products if the
information prescribed in specific other legislation is not indicated on the outer or
the immediate packaging.
Section 10
(1)1 One or more mock-ups of the outer packaging and the immediate packaging of
a medicinal product, together with the draft package leaflet, shall be submitted to the
government body for pharmaceuticals enclosed with the request for marketing
authorization.
(2)2 Applications for the authorization of changes pertaining to labeling and the
package leaflet, which do not effect the summary of product characteristics, shall be
submitted to the government body for pharmaceuticals. If the government body for
pharmaceuticals fails to render its decision within ninety days following the date of
receipt of the application for modification, the authorization shall be considered
granted.
(3) The package leaflet must be written and designed to be clear and
understandable, enabling the users to act appropriately, when necessary with the
help of health professionals. The package leaflet must be clearly legible in the
Hungarian language and shall contain the information prescribed in specific other
legislation. Apart from Hungarian the leaflet may be printed in several languages,
provided that the same information is given in all the languages used.
(4)3 The government body for pharmaceuticals may exempt packagings and
package leaflets for specific medicinal products from the obligation that all
particulars shall appear and that the packaging and the leaflet must be in Hungarian,
when the product is not intended to be delivered directly to the patient for
self-administration, or where there are severe problems in respect of the availability
of the medicinal product, or if the marketing authorization was granted under
Subsection (1) of Section 6, and it does not jeopardize the health of patients.
(5)4
Wholesale Distribution of Medicinal Products
Section 11
2 Established: by Section 46 of Act CLXXIII of 2010. In force: as of 1. 01. 2011. Amended: by
subparagraph a) Section 55 of Act CLXXIII of 2010. In force: as of 1. 01. 2011. The amendement of
the paragraph was not possibble.
3 Established by Section 58 of Act LXXIX of 2012. Amended by Paragraph a) of Section 31 of Act
CLXXII of 2016.
4 Repealed: by subparagraph a) Section 56 of Act CLXXIII of 2010. No longer in force: as of 01. 01.
2011.
(1)1 Wholesale distribution of medicinal products shall comprise all activities

relating to the supply of medicinal products to retailers, including the storage and
transportation of medicinal products, exporting to and importing from States which
are parties to the EEA-Agreement, and exporting to States outside of this area, in
consequence of which medicinal products are conveyed from the manufacturer or
producer to persons authorized to supply medicinal products to the public. Unless
this Act contains provisions to the contrary, all activities relating to the wholesale
distribution of medicinal products must be authorized by the government body for
pharmaceuticals.
(2)2 The government body for pharmaceuticals shall grant the above-specified
authorization, if the applicant is able to satisfy the personnel and infrastructure
requirements set out in specific other legislation.
(3)3 Authorized wholesale distributors of medicinal products - subject to the
exceptions set out in other legislation - shall be authorized to sell, supply and/or
deliver medicinal products only to persons with authorization to engage in activities
for the wholesale distribution of medicinal products or for providing healthcare
services.
(4)4 The authority shall adopt a decision concerning applications for authorization
and for the amendment of existing authorizations within ninety days following the
date of receipt of the application. Wholesale distribution authorizations shall remain
valid until revoked.
(5)5 Where medicinal products are exported to a third country by a wholesaler, the
wholesaler shall take steps to ensure that the medicinal products are delivered to an
authorized wholesaler in the third country of destination, or to persons authorized or
entitled to supply medicinal products to the public in the third country of destination.
Parallel Import6
Section 11/A7
(1) In the case of parallel importation the parallel importer shall inform of the
proposed importation the holder of the marketing authorization for Hungary of the
imported medicinal product and the government body for pharmaceuticals, or the
European Medicines Agency if the medicinal product in question had been authorized
under Regulation (EC) No. 726/2004 of the European Parliament and of the Council,
thirty days before the proposed date of importation.
(2) The parallel importation of any medicinal product for which the government
body for pharmaceuticals has already granted a marketing authorization shall be
subject to authorization pursuant to the ministerial decree on the pursuit of the
business of wholesale distribution and parallel importation of medicinal products.
Supply of Medicinal Products
Section 12
2 Amended: by subparagraph b) paragraph (2) Section 106, subparagraph g) Section 108 of Act CIX
of 2006. In force: as of 01. 01. 2007.
3 Established by Section 100 of Act CI of 2021, effective as of 29 June 2021.
6 Enacted: by Section 77 of Act CCXII of 2012. In force: as of 2. 01. 2013.
(1) Supply of medicinal products shall comprise all the activities by which medicinal
products are made available directly to the users, including the manufacture,
production, storage and distribution of medicinal products.
(2)1 Unless otherwise provided for by law, medicinal products may be procured on
the behalf of and dispensed to patients by pharmacies.
(3)2 Unless otherwise prescribed by law, pharmacies may procure medicinal
products only from economic operators authorized to engage in activities relating to
the wholesale distribution of medicinal products.
(4)3 Where a pharmacy is unable to supply a particular medicinal product from
stock immediately, the patient concerned shall be informed of the estimated date of
availability.
(5)4 In the case defined in Subsection (2) of Section 16, institutional pharmacies
may procure medicinal products of which there is a shortage from other institutional
pharmacies as well.
(6)5 Institutional pharmacies may purchase supplies of medicinal products from the
body delegated to manage the Central Healthcare Reserve within the framework of
independent procurement procedures in accordance with the Government Decree on
the National System of Centralized Procurement of Medicinal Products, Medical
Devices and Disinfectants for Inpatient Medical Institutions.
Section 136
Section 147
Special Provisions Relating to Narcotic Drugs and Psychotropic Substances,

Medicinal Products Classified as Narcotics or Psychotropic Substances and
New Psychoactive Substances8
Section 15
(1)9 The activities governed by the relevant legislation relating to narcotic drugs,
psychotropic substances and new psychoactive substances may be carried out in
possession of a general research authorization or a single license issued for a specific
study, or in possession of an official certificate issued after registration. The decisions
of the government body in charge of the healthcare system adopted in proceedings
under this Subsection may not be appealed.
(2) The regulations pertaining to the manufacture, storage and wholesale
distribution of medicinal products classified as narcotic and psychotropic substances,
as well as the registration and data disclosure obligations of the persons authorized
to engage in these activities, furthermore, the regulations for the prescription of
these products, their sale in pharmacies - including storage, records, and their
dispensation from pharmacies -, and for the use of these products in medical
institutions and the records on such usage is laid down in specific other legislation.
1 Established: by Section 48 of Act CLXXIII of 2010. In force: as of 1. 01. 2011.
4 Enacted: by Section 71 of Act CLIV of 2011. In force: as of 26. 11. 2011.
6 Repealed with preceding subtitle: by subparagraph b) Section 56 of Act CLXXIII of 2010. No
longer in force: as of 01. 01. 2011.
7 Repealed with preceding subtitle: by subparagraph c) Section 56 of Act CLXXIII of 2010. No
9 Established: by paragraph (1) Section 79 of Act CCXII of 2012. In force: as of 1. 01. 2013.
(3)1 The authorization and registration proceedings relating to narcotic drugs,

psychotropic substances and new psychoactive substances, and the issue and
amendment of authorizations shall be subject to an administrative service fee payable
in accordance with the provisions of specific other legislation.
(3a)2 The administrative time limit for the procedures described in Subsection (3)
shall be seventy-five days.
(4)3 The authorization referred to in Subsection (1) may be granted to an whose
executive officer has no prior criminal record and who is not restrained by court
order from exercising the profession required for holding an executive office in an
economic operator or business association, or from practicing the profession required
for the pursuit of healthcare activities.
(5)4 The person nominated to be appointed as narcotics duty officer, deputy
narcotics duty officer or as a person responsible for narcotic drugs or his deputy
under specific other legislation shall have no prior criminal record and shall not be
restrained by court order from practicing the profession required for the pursuit of
healthcare activities.
(6)-(7)5
(8)6 Enclosed with the application submitted for authorization by a person of
citizenship other than Hungarian, the applicant shall produce the translation of
official documentary evidence made out according to the laws of his home state -
pertaining to official certificates - to the authority delegated under specific other
legislation to verify that he has no prior criminal record, and that he is not restrained
by court order from practicing the profession referred to in Subsection (4) or (5).
(9)7 The government body in charge of the healthcare system shall maintain an
official public register on authorizations for activities with narcotic or psychotropic
substances, or with new psychoactive substances. Such register shall be construed as
an official public register in respect of Paragraphs b)-d) of Subsection (10).
(10)8 The register referred to in Subsection (9) shall contain the economic
operator’s:
a) name,
b) registered office,
c) places of business,
d) authorization number and the period of validity,
e) sphere of activities,
f)9 registered number, or court registration number if the economic operator
functions in a form other than a business association, or registration number in the
case of budgetary authorities,
g)10 designated employee responsible for narcotic drugs.
2 Enacted by Subsection (2) of Section 112 of Act CLXXXVI of 2015. Amended by Point 5 of Section
3 Established by paragraph (2) Section 79 of Act CCXII of 2012. Amended by Subsection (4) of
Section 10 of Act CCLII of 2013.
4 Enacted by paragraph (2) Section 76 of Act CLIV of 2009. Amended by subparagraph c) Section
88 of Act CCXII of 2012, Section 29 of Act LIX of 2017.
5 Repealed by Paragraph b) of Section 113 of Act CLXXXVI of 2015, effective as of 1 January 2016.
6 Enacted: by paragraph (2) Section 76 of Act CLIV of 2009. In force: as of 1. 01. 2010.
7 Established by Subsection (1) of Section 40 of Act XXXIV of 2016, effective as of 1 July 2016.
8 Enacted: by Section 101 of Act CXXVII of 2013. In force: as of 6. 07. 2013.
10 Enacted by Subsection (3) of Section 40 of Act XXXIV of 2016, effective as of 1 July 2016.
(11)1 The government body in charge of the healthcare system shall maintain a
register on acquirers of poppy seeds contaminated with unpurified industrial poppy
straw residues and non-shelled poppy-heads, and economic operators carrying out
the separation and cleaning thereof, and the sealing of poppy seeds after purification,
pelleting industrial poppy straw, and the storage of industrial poppy straw,
non-shelled poppy-heads and cannabis, and hemp with high THC content, including
the destruction thereof.
(12)2 The register referred to in Subsection (11) shall contain:
a) the economic operator’s:
aa) name,
ab) registered office,
ac) places of business;
b) the number of the official instrument;
c) positive indication of the nature of the activity and the place where it takes place;
d) the name of the person responsible for narcotic drugs;
e)3 the registered number or the number of admission into the official register of
private entrepreneurs, or the registration number in the case of budgetary
authorities;
f)4 the name of the controlled substance affected by the activity;
g)5 brief description of the storage facility and the storage protocol;
h)6 description of safety equipment and security measures;
i)7 the name of the authorized entity contractually linked with the economic
operator;
j)8 the subcontractor’s name.
(13)9 The register referred to in Subsection (11) shall be construed as an official
public register having regard to the data under Paragraphs a)-c) of Subsection (12).
(14)10 The government body in charge of the healthcare system shall maintain a
register on economic operators engaged in the transport of narcotic drugs,
psychotropic substances and new psychoactive substances.
(15)11 The register referred to in Subsection (14) shall contain:
a) the economic operator’s:
aa) name,
ab) registered office;
b) the number of the official instrument;
c) positive indication of the nature of the activity;
d) the name of the person responsible for narcotic drugs;
e)12 the registered number or the number of admission into the official register of
private entrepreneurs, or the registration number in the case of budgetary
authorities.
(16)13 The register referred to in Subsection (14) shall be construed as an official
public register having regard to the data under Paragraphs b)-d) of Subsection (15).
1 Established by Subsection (1) of Section 14 of Act CLXXXVIII of 2017, effective as of 1 January

2018.
9 Enacted by Section 101 of Act CXXVII of 2013. Amended by Paragraph a) of Section 45 of Act
XXXIV of 2016.
13 Enacted by Section 101 of Act CXXVII of 2013. Amended by Paragraph b) of Section 45 of Act
XXXIV of 2016.
Section 15/A1
(1)2 The authority delegated under specific other legislation shall check in the
course of a regulatory inspection as to whether the head of the authorized economic
operator has no prior criminal record and that he is not restrained by court order
from practicing the profession referred to in Subsection (4) or (5) of Section 15.
(2) With a view to being able to verify the circumstances referred to in Subsection
(1), the authority delegated under specific other legislation shall be authorized to
process the personal data:
a) of the person applying for authorization,
b) of the person holding an authorization,
contained in the official certificate made out by the body operating the penal register
for this purpose.
(3) The authority delegated under specific other legislation shall be authorized to
process the personal data obtained under Subsection (2):
a)3 until the conclusion of the procedure for authorization by definitive decision, or
b)4 for the duration of the regulatory inspection if the authorization is granted, or
until the conclusion of the procedure for the withdrawal of the authorization by
definitive decision.
Section 15/B5
(1)6 A specific substance or compound may be classified as new psychoactive

substance following prior scientific evaluation of the notification referred to in Article
5a of Regulation (EC) No. 1920/2006 of the European Parliament and of the Council
of 12 December 2006 on the European Monitoring Centre for Drugs and Drug
Addiction (hereinafter referred to as “notification”).
(2)7 The substances and compounds classified as new psychoactive substances shall
be defined by the minister in charge of the healthcare system by means of a decree.
(3)8 The prior scientific evaluation referred to in Subsection (1) shall be aimed at
determining whether there is any information available to the relevant Hungarian
authorities or expert institutions relating to the substance or compound indicated in
the notification:
a) that would imply the medicinal use of the substance or compound indicated in
the notification, and
b) that would exclude that the substance or compound pose a comparable threat to
public health as the narcotic drugs referred to in Point 4 of Section 1 or as the
substances contained in Lists I and II of Law-Decree No. 25 of 1979 promulgating the
Convention on Psychotropic Substances done at Vienna on 21 February 1971, or in
the lists of Annex 2.
(4) The prior scientific evaluation referred to in Subsection (1) hereof shall be
carried out by an expert body designated by government decree.
Section 15/C9
1 Enacted: by Section 77 of Act CLIV of 2009. In force: as of 1. 01. 2010.

2 Amended by Paragraph b) of Section 48 of Act CCXXIV of 2015.
3 Amended by Paragraph b) of Section 255 of Act L of 2017.
4 Amended by Paragraph b) of Section 255 of Act L of 2017.
5 Enacted: by Section 86 of Act CLXXVI of 2011. In force: as of 1. 03. 2012. Preceding subtitle was
repealed: by subparagraph c) Section 89 of Act CCXII of 2012. No longer in force: as of 1. 01.
2013.
6 Established by Section 36 of Act CXXI of 2019, effective as of 1 January 2020.
7 Established by Section 85 of Act CXI of 2014, effective as of 1 January 2015.
8 Established by Section 179 of Act LXVII of 2016, effective as of 17 July 2016.
(1)1 Within one years of classification of substances as new psychoactive

substances, the risk assessment of such new psychoactive substances shall be carried
out having regard to the assessments and opinions provided for in the relevant
government decree, if it was not requested by the Council of the European Union or
the World Health Organization.
(2)2 If based on the risk assessments of new psychoactive substances carried out in
Hungary or at Union level, or by the special UN bodies it is determined that such
psychoactive substances pose a comparable threat to public health as the narcotic
drugs referred to in Point 4 of Section 1 or as the substances contained in Lists I and
II of Law-Decree No. 25 of 1979 promulgating the Convention on Psychotropic
Substances done at Vienna on 21 February 1971, or in Lists A) and B) of Annex 2,
they shall be listed in the appropriate schedules of psychotropic substances, and
classification as a new psychoactive substance shall be withdrawn.
(3)3 If the risk assessment offers no evidence that a new psychoactive substance
poses a comparable threat as the narcotic drugs referred to in Point 4 of Section 1 or
as the substances contained in Lists I and II of Law-Decree No. 25 of 1979
promulgating the Convention on Psychotropic Substances done at Vienna on 21
February 1971, or in the lists of Annex 2, it shall be deleted from the list of new
psychoactive substances and shall be allocated to another list provided for in a
government decree.
(4)4 If according to the findings of the expert body, the data available is insufficient
to conclude the risk assessment within one year in accordance with Council Decision
2005/387/JHA of 10 May 2005 on the information exchange, risk-assessment and
control of new psychoactive substances, the classification of the new psychoactive
substance may be extended, with the proviso that risk assessment shall be carried
out every two years until such time when sufficient data is available for the exclusion
or substantiation of risks.
Section 15/D5
(1) The government body for pharmaceuticals shall maintain an official public
register on all medicinal products containing narcotic or psychotropic substances
with marketing authorization.
(2) The register referred to in Subsection (1) shall contain:
a) the medicinal product’s name and pharmaceutical form;
b) the medicinal product’s classification;
c) the medicinal product’s status;
d) quantification of the active substance in a dosage unit;
e) the international non-proprietary name of the medicinal product’s active
substance;
f) the medicinal product’s marketing authorization number;
g) the holder of the medicinal product’s marketing authorization;
h) the medicinal product’s sales presentation,
i) the legal status of the medicinal product for dispensing;
j) the list of countries where the medicinal product cannot be marketed.
Sections 15/E-15/F6
1 Amended by subparagraph a) Section 65 of Act LXXIX of 2012, subparagraph e) Section 88 of Act

CCXII of 2012, Paragraph b) of Section 31 of Act CLXXII of 2016.
4 Established by Section 86 of Act CXI of 2014, effective as of 1 January 2015.
6 Repealed: by subparagraph e) Section 89 of Act CCXII of 2012. No longer in force: as of 1. 01.
2013.
Public Service Obligation Placed on Marketing Authorization Holders,

Authorized wholesale distributors of medicinal products and Operators of
Pharmacies Relating to the Supply of Medicinal Products
Section 16
(1)1 In the event where a marketing authorization holder intends to temporarily
suspend the distribution of a specific medicinal product in the territory of Hungary,
or wishes to discontinue the distribution of such medicinal product, the wholesalers
of medicinal products engaged under contract and the government body for
pharmaceuticals must be notified accordingly at the time of delivery of the last
production batch to the medicinal product wholesaler, in any case at least two
months before the scheduled suspension or termination of distribution, and shall be
liable to provide a supply of the medicinal products in question until the date
estimated for the suspension or termination of distribution in the quantity required to
cover demand as estimated from previous turnover data. The government body for
pharmaceuticals shall verify the availability of supplies notified by the marketing
authorization holder in the quantity estimated to satisfy demand.
(1a)2 The marketing authorization holder shall disclose the reasons for the
suspension or termination of distribution provided for in Subsection (1) to the
government body for pharmaceuticals, and shall enclose a statement indicating if the
suspension or termination is required on the grounds mentioned in Paragraphs a)-e)
of Subsection (5) of Section 18.
(2)3 Where a marketing authorization holder or - in the case of medicinal products
with public financing, if the marketing authorization holder is not engaged in any
distribution activities in Hungary - the distributor is unable to maintain adequate and
continuous supplies of specific medicinal products in Hungary, or if unable or
unwilling to supply the preparation temporarily or permanently, the marketing
authorization holder shall forthwith notify the wholesalers of medicinal products
engaged under contract, the government body for pharmaceuticals and - in the case
of medicinal products with public financing - the health insurance administration
agency accordingly, and shall communicate the expected duration of such shortage
and the quantity of supplies available during this period.
(2a)4 The continuous supply of medicinal products with public financing shall be
the responsibility of the marketing authorization holder, if the marketing
authorization holder does not carry out distribution activities in Hungary, the
distributor (hereinafter referred to as “authorized distributor”).
(2b)5 The government body for pharmaceuticals may declare a shortage of
specific medicinal products, or the risk thereof, relying on information obtained in
carrying out its tasks delegated by law, even in the absence of notification under
Subsection (2). The government body for pharmaceuticals may declare a shortage of
particular medicinal products, even if the medicinal product in question has not been
authorized for marketing.
1 Established by Subsection (1) of Section 56 of Act CCXLIV of 2013, effective as of 24 December

2013.
2 Enacted by Subsection (2) of Section 56 of Act CCXLIV of 2013, effective as of 24 December 2013.
2018.
4 Established by Subsection (1) of Section 238 of Act XCIX of 2021, effective as of 1 December
2021.
5 Established by Subsection (1) of Section 238 of Act XCIX of 2021, effective as of 1 December
2021.
(2c)1 In the event of a shortage or risk of shortage of a medicinal product as

declared according to Subsection (2) or (2b), the government body for
pharmaceuticals may order the marketing authorization holder or the authorized
distributor to resolve the shortage by obtaining a suitable replacement for the
medicinal product in shortage. In its decision the government body for
pharmaceuticals shall provide for:
a) the medicinal product considered a suitable replacement for the medicinal
product in shortage, and
b) the requirements for the provision of accompanying documents in Hungarian
and for packaging.
(2d)2 The marketing authorization holder and the authorized distributor may be
declared jointly and severally liable for the decision referred to in Subsection (2c).
(2e)3 If the shortage has been established in respect of a medicinal product not
authorized for marketing in Hungary, or the decision referred to in Subsection (2c) is
not expected to resolve the medicinal product shortage, or the decision published
failed to bring the results desired, the government body for pharmaceuticals shall - at
the request of the wholesaler of medicinal products - authorize the purchase of a
medicinal product considered a suitable replacement for the medicinal product in
shortage. In the authorization the wholesaler of medicinal products is given authority
to import the medicinal product specified therein in the quantity and for a period of
time specified in the decision (hereinafter referred to as “quota authorization”).
Paragraphs a) and b) of Subsection (2c) shall apply to the content of the quota
authorization.
(2f)4 The obligor of the decision provided for in Subsection (2c) and the holder of
the quota authorization shall report to the government body for pharmaceuticals the
importation of the medicinal product for the purpose of resolving the shortage within
eight days of the date of import, indicating the quantity.
(2g)5 The government body for pharmaceuticals shall publish on its website an
extract of the decision referred to in Subsections (2c) and (2e), and the fact of actual
importation pursuant to Subsection (2f).
(2h)6 Where medicinal products imported to Hungary for distribution are sold or
exported to a foreign country, the wholesaler of medicinal products shall disclose to
the government body for pharmaceuticals the quantity of the medicinal products in
question within eight days.
(3) Authorized wholesale distributors of medicinal products shall be required to
procure and supply the medicinal products to which their authorization for wholesale
distribution pertains.
(3a)7 In the context of the distribution activities referred to in Subsection (3), the
authorized wholesale distributor of medicinal products shall, apart from the balanced
satisfaction of orders in the framework of ordinary course of business, take into
account patient care requirements as well.
(4) The supply obligation of operators of pharmacies is governed in specific other
legislation on the implementation and operation of pharmacies.
1 Enacted by Subsection (2) of Section 238 of Act XCIX of 2021, effective as of 1 December 2021.
(5)1 The marketing authorization holder shall ensure that any medicinal product
wholesaler authorized in Hungary shall be given adequate opportunity for the
distribution of the marketing authorization holder’s medicinal products on the
wholesale market, if the wholesaler makes a statement specifically indicating that the
medicinal product is requested for satisfying patient care requirement in Hungary.
The medicinal products procured under this Subsection may be sold to Hungarian
healthcare service providers only, and may not be exported within the framework of
wholesale trading activities. The wholesaler shall keep records of the medicinal
products purchased under this Subsection separately, as decreed by the minister in
charge of the healthcare system. The marketing authorization holder shall be relieved
of the obligation provided for in this Subsection of supplying wholesalers of medicinal
products if:
a) the medicinal product in question is indicated in the notice published by the
government body for pharmaceuticals as referred to in Subsection (6) of Section 16,
b) the wholesaler made losses during the year previous to the time of placing the
order, or
c) the wholesaler was found guilty by final decision for the unlawful exportation of
medicinal products over a period of five years before the time of placing the order.
(5a)2 The marketing authorization holder shall ensure that the medicinal product
wholesalers authorized in Hungary for the wholesale distribution of medicinal
products together shall have adequate supplies of medicinal products of the active
substance decreed by the minister in charge of the healthcare system available at
their disposal in the territory of Hungary, in the quantity defined therein. The types
of active substances referred to above shall be defined on a recommendation by the
(6)3 The government body for pharmaceuticals shall publish the notice referred to
in Subsection (2) on its website, and shall - in the case of medicinal products with
public financing - notify the administrator of state healthcare, catastrophe and safety
reserves thereof.
(7)4 In the case provided for in Subsection (4) of Section 21 of Act XCVIII of 2006
on the General Provisions Relating to the Reliable and Economically Feasible Supply
of Medicinal Products and Medical Aids and on the Distribution of Medicinal Products
(hereinafter referred to as “Medicine Act”), the marketing authorization holder and
wholesalers of medicinal products are required to cooperate as decreed by the
minister in charge of the healthcare system with the administrator of state
healthcare, catastrophe and safety reserves, the government body for
pharmaceuticals and the health insurance administration agency in the interest of
control of the shortage.
(8)5 If the government body for pharmaceuticals obtains information regarding the
export of medicinal products originally intended to be supplied in Hungary to the
general public to an extent where it is considered to jeopardize the continuous supply
of the medicinal products in question, the government body for pharmaceuticals shall
have authority to ban - for a period not exceeding one year - further export of the
medicinal product within the framework of wholesale trading activities so as to
guarantee the security of supply, if it considers that further exports are likely to
disturb the supply of medicinal products.
(9)6 The marketing authorization holder shall notify the government body for
pharmaceuticals without delay:

3 Established by Subsection (2) of Section 87 of Act CXI of 2014, effective as of 1 January 2015.
4 Established by Subsection (2) of Section 87 of Act CXI of 2014, effective as of 1 January 2015.
a) concerning all measures taken in a State that is a party to the EEA Agreement
for the suspension of distribution of a medicinal product, for recalling a medicinal
product, or for requesting the withdrawal of marketing authorization, including the
reasons,
b) if did not apply for the renewal of marketing authorization for a medicinal
product in a State that is a party to the EEA Agreement, including the reasons.
(10)1 The notice under Subsection (9) shall have enclosed a statement indicating if
the measure was required on the grounds mentioned in Paragraphs a)-e) of
Subsection (5) of Section 18.
(11)2 The notice referred to in Subsection (9) shall be submitted also if the
marketing authorization holder took the actions referred to in Paragraphs a) and b) of
Subsection (9) in a third country, if they were required on the grounds mentioned in
Paragraphs a)-e) of Subsection (5) of Section 18.
(12)3 The marketing authorization holder shall also notify the European Medicines
Agency of having taken the actions referred to in Paragraphs a) and b) of Subsection
(9), indicating if they were required on the grounds mentioned in Paragraphs a)-e) of
Subsection (5) of Section 18.
Section 16/A4
(1) Marketing authorization holders, authorized wholesale distributors of medicinal

products, and operators of pharmacies shall ascertain the compliance of Directive
2001/83/EC of the European Parliament and of the Council with Commission
Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive
2001/83/EC of the European Parliament and of the Council by laying down detailed
rules for the safety features appearing on the packaging of medicinal products for
human use (hereinafter referred to as “Regulation 2016/161/EU”).
(2) The national repository in which information on the safety features are stored,
as provided for in point (e) of Article 54a(2) of Directive 2001/83/EC of the European
Parliament and of the Council and in Article 31 of Regulation 2016/161/EU shall be
established, managed and operated by the Hungarian non-profit organization for the
identification of medicinal products (hereinafter referred to as “non-profit
organization for the identification of medicinal products”).
(3) Holders of marketing authorizations for medicinal products within the scope
defined in Article 2 of Regulation 2016/161/EU shall be liable to pay a service fee for
using the services related to the national repository operated by the Hungarian
non-profit organization for the identification of medicinal products. The Hungarian
non-profit organization for the identification of medicinal products is required to
publish the service fees established and charged and the related contract terms on its
website.
(4) The government body for pharmaceuticals shall make available on its website at
all times information as to the medicinal products covered by the scope defined in
Article 2 of Regulation 2016/161/EU.
(5) The non-profit organization for the identification of medicinal products is
entitled to provide data to the government body for pharmaceuticals on marketing
authorization holders:
a) with which it has concluded a contract for the use of services related to the
national repository provided for in Subsection (2), or whose contract has been
terminated,
4 Established by Section 101 of Act CI of 2021, effective as of 29 June 2021.
b) which actually uses the services of the Hungarian non-profit organization for the
identification of medicinal products or the national repository it operates, however, it
has not concluded a contract with the Hungarian non-profit organization for the
identification of medicinal products to that effect,
c) which has entered into a contract with the Hungarian non-profit organization for
the identification of medicinal products, but has not paid the relevant service fees
due to the Hungarian non-profit organization for the identification of medicinal
products,
d) in respect of which the Hungarian non-profit organization for the identification of
medicinal products has restricted end-user access to the data uploaded to the
national repository referred to in Subsection (2) by the marketing authorization
holder (suspension of service).
Supervision and Regulatory Control of Medicinal Products and the Supply of

Medicinal Products
Section 17
(1)1 Holders of marketing authorization and pharmacists engaged in the wholesale
distribution of medicinal products or in the supply of medicinal products to the
public, retail suppliers of medicinal products other than pharmacies, as well as the
doctors administering the medicinal products shall report any suspected deficiency in
the quality of a medicinal product or production batch, and information on any
suspected falsified medicinal product to the government body for pharmaceuticals
without delay upon gaining knowledge about such deficiency.
(2) The party reporting a suspected deficiency in quality shall, at the time of
reporting, provide a specimen of the medicinal product in question, in the volume
prescribed in specific other legislation for the purpose of quality control.
(2a)2 The government body for pharmaceuticals shall have powers to check the
quality of any medicinal products produced or marketed in Hungary, including the
documents pertaining to production or marketing, and shall be entitled to take
samples and second samples for counter analysis at its own expense, unless these
costs are charged to others by law.
(3)3 If the government body for pharmaceuticals finds, in connection with the
report referred to in Subsection (1), or on the basis of the proceedings opened under
Subsection (2a) or of information received through other channels, that a medicinal
product does not comply with the requirements specified in the marketing
authorization, and/or in Regulation 2016/161/EU, or its quality cannot be verified or
any suspected deficiency in its quality arises, it shall order the suspension of
distribution of the medicinal product or production batch in question, or to have them
withdrawn from the market or recalled. The government body for pharmaceuticals
shall publish on its website the operative part of the decision thereof and a summary
of the ascertained facts of the case with the date of publication, the number and the
subject matter of the case, as well as the holder of the marketing authorization and
the relevant medicinal product also indicated, with business secrets removed. The
procedure for withdrawal from the market, recall and for the suspension of
distribution shall be decreed by the minister in charge of the healthcare system.
(4)4
3 Established by Section 17 of Act CLXXXVIII of 2017. Amended by Point 6 of Section 109 of Act CI
of 2021.
4 Repealed: by Section 109 of Act CXXVII of 2013. No longer in force: as of 6. 07. 2013.
(5)1 The costs for the withdrawal of a medicinal product from the market, for
suspension of distribution, recall and collection and the costs of prohibition of use -
including the cases defined in Subsections (1)-(3) hereof, Subsection (5) of Section 18
and in Paragraph c) of Subsection (3) of Section 20 - and where the related medicinal
products are exchanged by the pharmacy, with the exception of measures taken in
connection with falsified medicinal products, shall be borne by the marketing
authorization holder.
(6)2 In proceedings for the recall, suspension or prohibition of the use of a
medicinal product, the government body for pharmaceuticals shall provide for the
repayment of the reimbursement amount or consumer price incurred by the patient.
Section 17/A3
(1) Where a medicinal product for which the government body for pharmaceuticals
has already granted a marketing authorization is not actually present on the market
in Hungary for three consecutive years, the marketing authorization of such
medicinal product shall be cancelled by decision of the government body for
pharmaceuticals.
(2) Under patient care interests deserving special consideration or in order to
prevent any disturbance in the supply of medicinal products, the government body for
pharmaceuticals may disregard the provisions contained in Subsection (1).
Section 17/B4
(1)5 With a view to ascertaining the relevant facts of the case, the government body
for pharmaceuticals shall have authority to request in the course of regulatory
control procedures and during administrative proceedings any person and
organization to make a statement, and when so requested by the government body
for pharmaceuticals any person and organization shall be liable to make available
data from their records and copies of documents in their possession with facilities for
reading and copying to the government body for pharmaceuticals. The government
body for pharmaceuticals shall have powers to make a hard mirror image of the data
medium held by any person, and to inspect the contents through this image if there is
reason to believe that it contains information relating to the proceedings conducted
under Section 20 within the framework of regulatory inspections.
(2) With a view to ascertaining the relevant facts of the case in connection with
proceedings conducted within the framework of regulatory inspections, the
government body for pharmaceuticals shall have authority to access the records of
other authorities for data obtained during their inspections.
(3) The government body for pharmaceuticals shall be entitled to inspect and
process - in connection with proceedings conducted within the framework of
regulatory inspections - the personal data of the client and other persons who may be
tied to the client. Where a means of evidence contains personal data that does not
pertain to the investigation, and if this data cannot be detached without
compromising the probative value of the evidence, the government body for
pharmaceuticals shall be entitled to process all personal data affected, however, the
entitlement to inspect the personal data that does not pertain to the investigation is
valid only to the extent required to ascertain that the data is not connected to the
infringement investigated.
2 Enacted by Section 102 of Act CI of 2021, effective as of 29 June 2021.
5 Amended by Paragraph c) of Section 255 of Act L of 2017.
(4) In connection with proceedings conducted within the framework of regulatory

inspections, the government body for pharmaceuticals shall have authority to search
any premises, to access such premises under probable cause under his own authority,
without the consent of the owner (tenant) or any other person in the premises, and to
open any sealed-off area or building for this purpose. In the process of the search the
acting officer shall be entitled to demand information, written or oral, from the client,
the client’s representative (former representative) or employee (former employee),
and may gather intelligence in any other way. An on-site inspection may be carried
out in the private domain, including vehicles and other premises, if it is in the use of
any former or current executive officer of the client, employee or representative, or
any other person who effectively exercises control or who used to exercise control.
(5) The investigative measures specified under Subsection (4) shall be carried out
subject to the public prosecutor’s prior consent. The prosecuting authority shall
authorize the above-specified investigative measure if the government body for
pharmaceuticals is able to substantiate probable cause that any other investigative
measure is unlikely to produce the required results, and if there is reason to believe
that the source of information - relating to the illegal activity investigated - indicated
is in the location for which the court order is requested and it is presumed that this
information will not be surrendered voluntarily or that it would be destroyed. If the
investigative measure is only partially accepted, the prosecuting authority shall
specify the type of procedure and the person who is the subject of such procedure.
On the basis of having in possession the prosecuting authority’s consent the
investigative measure may be carried out within a period of ninety days from the date
of issue.
(6) Regarding the investigative measure carried out under Subsection (4) the
persons affected shall be informed verbally at the time the investigative measure
commences, and it shall be carried out if possible in the presence of these persons.
Before the investigative measure is carried out the prosecuting authority’s consent
shall be presented and the purpose of the investigative measure shall be
communicated.
(7) Upon hearing a witness, the government body for pharmaceuticals may ex
officio order to keep the witness’s data confidential if deemed necessary with a view
to ascertaining the relevant facts of a case.
(8)1 The administrative time limit for proceedings conducted within the framework
of regulatory inspections shall be ninety days.
Pharmacovigilance2
Section 183
(1)4 Marketing authorization holders shall record all suspected adverse reactions in
the States which are parties to the EEA-Agreement or in third countries which are
brought to their attention, whether reported spontaneously by patients or healthcare
professionals, or occurring in the context of a post-authorization study.
(2) Healthcare professionals shall be required to report any suspected adverse
reaction discovered or noticed to the government body for pharmaceuticals without
delay. The government body for pharmaceuticals shall record - by way of the means
specified in the relevant legislation - and forward all suspected adverse reactions that
occur in the territory of Hungary which are brought to its attention from healthcare
professionals and patients.
1 Amended by Paragraph c) of Section 113 of Act CLXXXVI of 2015.

3 Established: by Section 87 of Act CLXXVI of 2011. In force: as of 21. 07. 2012.
4 Amended: by subparagraph g) Section 88 of Act CCXII of 2012. In force: as of 1. 01. 2013.
(3) The government body for pharmaceuticals shall be informed of any suspected
adverse reactions arising from an error associated with the use of a medicinal
product that are brought to the attention of an authority.
(4)1 The government body for pharmaceuticals shall evaluate the data relating to
pharmacovigilance, and - if urgent action is considered necessary - inform other
Member States of the European Union and the European Medicines Agency. If the
European Medicines Agency decides not to conduct an urgent Union procedure, the
government body for pharmaceuticals shall proceed to take the necessary measures
under Subsections (7) and (8). The government body for pharmaceuticals shall inform
the notifier, the marketing authorization holder and - by way of public notice - the
healthcare service providers affected concerning the measures taken and the
underlying particulars, and shall proclaim its decision on such actions to the general
public on its website as well.
(5)2 The government body for pharmaceuticals may suspend further distribution of
a medicinal product, order to have them withdrawn from the market or recalled, and
may prohibit the use of such medicinal product if:
a) the information brought to its attention indicate that the medicinal product is
harmful;
b) the information brought to its attention indicate that therapeutic results cannot
be obtained from the medicinal product;
c) the information brought to its attention indicate that the risk-benefit balance of
the medicinal product has changed to the point where safe use of the medicinal
product can no longer be ascertained;
d) the qualitative and quantitative composition of the medicinal product is not as
declared in the marketing authorization;
e)3 the controls on the medicinal product and/or on the ingredients and the controls
at an intermediate stage of the manufacturing process have not been carried out or if
some other requirement or obligation relating to the grant of the manufacturing
authorization, or the active substance of the medicinal product has not been fulfilled,
including if the medicinal product or its active substance was not manufactured in
accordance with good manufacturing practice;
f) the particulars supporting the application for marketing authorization or for its
renewal are incorrect or have not been amended;
g) the marketing authorization holder failed to apply for the amendment of the
marketing authorization in due time; or
h) so required in order to comply with the request received from the European
Commission.
(6) The government body for pharmaceuticals shall revoke the marketing
authorization if:
a) it considers that the problems specified in Paragraphs a)-d) of Subsection (5)
cannot be remedied within any foreseeable period of time; or
b) the marketing authorization holder failed to remedy the discrepancies by the
deadline prescribed in the resolution referred to Subsection (5);
c) the marketing authorization holder failed to satisfy the special requirements set
out in the marketing authorization.
1 Amended by Paragraph d) of Section 255 of Act L of 2017.

2 Established by Section 42 of Act XXXIV of 2016, effective as of 1 July 2016.
(7) When urgent action under Subsections (5) and (6) is considered necessary as a
result of the evaluation of data resulting from pharmacovigilance activities, it may be
carried out if the government body for pharmaceuticals notifies the European
Commission, the European Medicines Agency and other States which are parties to
the EEA Agreement on the proposed measures and the reasons in advance, after
which the Agency declares its decision not to initiate an urgent Union procedure
upon the notification. However, if the application of Subsection (5) is nevertheless
deemed necessary for public health reasons as temporary measures, the government
body for pharmaceuticals may convey the information mentioned in this Subsection
on the next working day after the day when the action was carried out. This
Subsection shall not apply if the action was carried out pursuant to Paragraph h) of
Subsection (5) or to Subsection (8).
(8)1 Furthermore, the government body for pharmaceuticals may suspend, revoke
or refuse renewal of a marketing authorization based on a unanimous decision
adopted by the coordination group of the European Medicines Agency, or based on
the European Commission’s decision, or may encourage the marketing authorization
holder to apply for the amendment of the marketing authorization as appropriate,
and to apply for the authorization of marketing under the conditions of controlled
distribution provided for in the international regulatory regime applicable to
pharmacovigilance.
(9) Where a medicinal product has been withdrawn from the market in accordance
with this Section, and there is no suitable replacement available, the government
body for pharmaceuticals may allow - during a transitional period - the supply of the
medicinal product to patients who are already being treated with the medicinal
product.
Section 18/A2
(1) The government body for pharmaceuticals shall operate a pharmacovigilance

system to collect information on the risks of medicinal products as regards patients’
or public health. That information shall in particular refer to adverse reactions in
human beings, arising from use of the medicinal product within the terms of the
marketing authorization as well as from use outside the terms of the marketing
authorization, and to adverse reactions associated with occupational exposure.
(2) The government body for pharmaceuticals shall evaluate all information
collected by means of the pharmacovigilance system referred to in Subsection (1)
scientifically, consider options for risk minimization and prevention and take
regulatory action concerning the marketing authorization as necessary.
(3) The government body for pharmaceuticals shall perform a regular audit of the
pharmacovigilance system it operates and report the results to the European
Commission on 21 September 2013 at the latest and then every two years thereafter.
(4) In order to improve the efficiency of the pharmacovigilance system, the
government body for pharmaceuticals shall:
a) encourage patients and healthcare professionals to report suspected adverse
reactions of medicinal products, and for these tasks, professional organizations and
non-governmental organizations may be involved as appropriate;
b) facilitate patient reporting of suspected adverse reactions through the provision
of alternative reporting formats in addition to web-based formats;
c) take all appropriate measures to obtain accurate and verifiable data for the
scientific evaluation of suspected adverse reaction reports;
d) ensure that the public is given important information on pharmacovigilance
concerns relating to the use of a medicinal product in a timely manner through
publication on the national web-portal and through other means of publicly available
information as necessary;
1 Amended by Point 7 of Section 109 of Act CI of 2021.

e) ensure, through the methods for collecting information and where necessary
through the follow-up of suspected adverse reaction reports, that all appropriate
measures are taken to identify clearly any biological medicinal product prescribed,
dispensed, or sold in Hungary which is the subject of a suspected adverse reaction
report, with due regard to the name of the medicinal product, in accordance with
Point 13 of Section 1, and the batch number.
Section 18/B1
The marketing authorization holder shall operate a pharmacovigilance system for

the fulfillment of his pharmacovigilance tasks equivalent to the pharmacovigilance
system mentioned under Subsection (1) of Section 18/A. The pharmacovigilance tasks
related to the pharmacovigilance system are laid down in the relevant legislation.
Section 18/C2
(1) The government body for pharmaceuticals shall set up and maintain a national
medicines web-portal which shall be linked to the European medicines web-portal
established in accordance with Article 26 of Regulation (EC) No. 726/2004 of the
European Parliament and of the Council of 31 March 2004 laying down Community
procedures for the authorization and supervision of medicinal products for human
and veterinary use and establishing a European Medicines Agency.
(2) By means of the national medicines web-portal, the following shall be made
publicly available:
a) public assessment reports, together with a summary thereof;
b) summaries of product characteristics and package leaflets;
c) summaries of risk management plans for authorized medicinal products;
d)3 the list of medicinal products referred to in Article 23 of Regulation (EC) No.
726/2004 of the European Parliament and of the Council of 31 March 2004 laying
down Community procedures for the authorization and supervision of medicinal
products for human and veterinary use and establishing a European Medicines
Agency which are subject to additional monitoring;
e) information on the different ways of reporting suspected adverse reactions to
medicinal products to national competent authorities by healthcare professionals and
patients, including the web-based structured forms referred to in Article 25 of
Regulation (EC) No. 726/2004 of the European Parliament and of the Council of 31
March 2004 laying down Community procedures for the authorization and
supervision of medicinal products for human and veterinary use and establishing a
European Medicines Agency.
Section 18/D4
(1) If the marketing authorization holder intends to make a public announcement

relating to information on pharmacovigilance concerns in relation to the use of a
medicinal product, he shall be required to inform the government body for
pharmaceuticals, the European Commission and the European Medicines Agency
concerning the contents of the announcement by way of the means set out in the
relevant legislation.
1 Enacted: by Section 88 of Act CLXXVI of 2011. In force: as of 21. 07. 2012. Amended: by
subparagraph b) Section 65 of Act LXXIX of 2012. In force: as of 22. 07. 2012.
3 Amended: by subparagraph c) Section 65 of Act LXXIX of 2012. In force: as of 22. 07. 2012. The
change does not effect the English version.
(2) When the government body for pharmaceuticals makes public information on
pharmacovigilance concerns, any information of a commercially confidential nature
shall be deleted unless its public disclosure is necessary for the protection of public
health. Information on pharmacovigilance concerns may contain the personal data of
a person affected only if deemed necessary to avert a life-threatening situation and if
the purpose of the information cannot be achieved otherwise.
Section 18/E1
Under the conditions set out in the relevant legislation marketing authorization
holders are required to submit periodic safety update reports.
Section 192
The government body for pharmaceuticals shall routinely inspect the laboratories
contracted for testing the safe use of medicinal products as well as medical service
providers conducting clinical trials for the purpose of checking their compliance with
the professional requirements laid down in specific other legislation
Section 20
(1)3 The government body for pharmaceuticals shall have authority to supervise
the obligations conferred under this Act or other legislation adopted by authorization
of this Act relating to the manufacture, distribution, placing on the market of
medicinal products, active substances and excipients, to pharmacovigilance,
brokering of medicinal products, as well as the public service obligation for the
supply of medicinal products, furthermore, to the clinical trial of investigational
products and the activities of laboratories contracted for testing medicinal products
for reasons of safety. The regulations concerning the promotion of medicinal products
and for the enforcement of the provisions relating to business-to-consumer
commercial practices relating to medicinal products shall be laid down in the Act on
the General Provisions Relating to the Reliable and Economically Feasible Supply of
Medicinal Products and Medical Aids and on the Distribution of Medicinal Products,
including the provisions for any infringement of these provisions.
(1a)4 As regards inspections carried out in Hungary and in third countries, the
government body for pharmaceuticals shall take into account the guidance published
by the European Commission and shall cooperate with the European Medicines
Agency, within the framework of which it shall share information with the European
Medicines Agency relating to proposed inspections and the findings of inspections
completed.
(2)5 In the control proceedings the government body for pharmaceuticals shall
establish the facts, and shall take the measures consistent with the nature and
severity of any discrepancies and irregularities and monitor their implementation,
and shall prepare an inspection report under the guidelines of the European
Commission and the European Medicines Agency, and/or in accordance with the
legislation implemented by authorization of this Act.

2007.
5 Amended by Paragraph b) of Subsection (2) of Section 106 of Act CIX of 2006, Paragraph b) of
Section 93 of Act CXI of 2014, Paragraph a) of Section 59 of Act LXXVII of 2015, Point 9 of Section
(3)1 Where the government body for pharmaceuticals finds that the authorized
natural or legal person is in non-compliance with the conditions and requirements set
out in this Act or any other legislation adopted by authorization of this Act, or is in
breach of the obligations conferred upon it, the government body for pharmaceuticals
may:
a) order the state of infringement to be terminated; or
b) prohibit continuation of the illegal conduct; or
c)2 order or initiate the medicinal product or the production batch that is deemed
harmful to life, health or physical safety or which do not comply with the
requirements laid down in Regulation 2016/161/EU to be removed from the market;
or
d)3 in its decision with warning, order the person affected to eliminate the
discrepancies within the prescribed deadline, or suspend his authorization until the
said discrepancies are eliminated; or
e)4 in the case of repeat offenders, or in connection with any severe infringement
constituting a public health emergency, revoke the authorization or such offenders or
shall remove them from the register where the activities are subject to notification.
(4)5 The government body for pharmaceuticals shall have power to impose an
administrative fine upon the person having committed the infringement. In the case
of multiple violations the amount of fines imposed may be cumulative.
(5)6 The amount of the fine imposed for any breach of the public service obligation
provided for in this Act concerning the supply of medicinal products shall be
determined having regard to the circumstances provided for in Subsection (1) of
Section 10 of Act CXXV of 2017 on Penalizing Administrative Infractions (hereinafter
referred to as “Sanctions Act”), and/or the scope and gravity of the injury caused to
patients. The fine shall be between one hundred thousand and five hundred million
forints. The circumstance referred to in Paragraph g) of Subsection (1) of Section 10
of the Sanctions Act shall apply in the application of this Act in the benefit of the
infringer solely in the case where the infringement committed had no impact on
patient safety or patient care interests.
(6)7 As regards the implementation of Subsection (2) of Section 18, additional
obligations of healthcare professionals are laid down in the relevant legislation.
(7)8 The above-specified fines shall be payable to the account of the imposing
(8) Other aspects in connection with the control of persons engaged in the supply of
medicinal products to the public are governed in specific other legislation.
(9)9 The definitive resolution of the government body for pharmaceuticals adopted
under Subsections (3) and (4):
a) imposing a fine in excess of one million forints, or
b) imposing a fine of less than one million forints in the case of repeat infringement,
shall be proclaimed with the contents specified in Subsection (10).
(10)10 The documents proclaimed as specified above shall indicate:
1 Established by paragraph (1) Section 50 of Act CLXXIII of 2010. Amended by Subsection (5) of
Section 10 of Act CCLII of 2013.
2 Established by Section 18 of Act CLXXXVIII of 2017, effective as of 9 February 2019.
3 Amended by Section 78 of Act CLXVIII of 2020.
5 Established by Subsection (1) of Section 76 of Act CLXVIII of 2020, effective as of 1 January 2021.
6 Established by Subsection (1) of Section 76 of Act CLXVIII of 2020, effective as of 1 January 2021.
8 Established: by paragraph (2) Section 21 of Act CLXVI of 2011. Amended by Paragraph b) of
Section 59 of Act LXXVII of 2015.
9 Enacted by Section 57 of Act CCXLIV of 2013. Amended by Paragraph b) of Section 93 of Act CXI
of 2014, Paragraph a) of Section 59 of Act LXXVII of 2015, Paragraph e) of Section 255 of Act L of
2017.
10 Enacted by Section 57 of Act CCXLIV of 2013. Amended by Paragraph f) of Section 255 of Act L of
2017.
a)1 the date when proclaimed;

b) the name of the competent authority;
c) the case number and the subject matter of the case;
d) the name of the infringer;
e) a summary statement of the relevant facts of the case;
f) the statutory provisions infringed upon;
g) the operative part of the decision; and
h) an indication if the decision has been appealed.
(11)2 Upon being apprised of the decision of an authority or a court ruling delivered
in the redress procedure for overturning such proclaimed decision, invoking changes
in such decision as to substance, the government body for pharmaceuticals shall -
immediately upon receipt of the authority’s decision or court ruling - proclaim, using
the same means:3
a) the information under Subsection (10) relating to the decision to which the
appeal pertains;
b) the decision of an authority or a court ruling adopted in the remedy proceedings,
including a brief explanation; and
c)4 the date when proclaimed.
(12)5 In the course of regulatory inspections and control procedures, the
government body for pharmaceuticals may order the sanctions described in
Paragraphs a)-d) of Subsection (3) also in the form of provisional measures.
(13)6 In cases falling within the competence of the government body for
pharmaceuticals in accordance with this Act and/or other legislation implemented by
authorization of this Act no administrative sanction may be imposed:
a) after two years following the time of the authority of jurisdiction for levying the
penalty gaining knowledge of the infringement, or
b) after five years from the time the infringement was committed.
Temporarily Rendering Electronic Information Inaccessible7
Section 20/A8
(1) The government body for pharmaceuticals shall order by way of a resolution the
rendering of information published by way of an electronic communications network
inaccessible temporarily (for the purposes of this subtitle hereinafter referred to as
“electronic information”) the publication or disclosure of which constitutes the
provision of access to fake or unauthorized medicinal products.
(2) The government body for pharmaceuticals shall order by means of a resolution
the temporary removal of electronic information so as to render such electronic
information inaccessible temporarily.
(3) The party bound by the obligation imposed by the resolution the government
body for pharmaceuticals has adopted under Subsections (1) and (2) shall be the
service provider and intermediary service provider provided for in the Act on
Electronic Commerce and on Information Society Services (for the purposes of this
Section hereinafter referred to collectively as “service provider”). The obligated party
shall remove the electronic information temporarily within one working day from the
time of delivery of the resolution.
1 Amended by Paragraph g) of Section 255 of Act L of 2017.

2 Enacted by Section 57 of Act CCXLIV of 2013. Amended by Paragraph b) of Section 93 of Act CXI
of 2014, Paragraph a) of Section 59 of Act LXXVII of 2015.
3 Amended by Paragraph h) of Section 255 of Act L of 2017.
4 Amended by Paragraph g) of Section 255 of Act L of 2017.
5 Enacted by Section 43 of Act XXXIV of 2016, effective as of 1 July 2016.
6 Enacted by Subsection (2) of Section 76 of Act CLXVIII of 2020, effective as of 1 January 2021.
7 Enacted by Section 88 of Act CXI of 2014, effective as of 1 January 2015.
(4) The government body for pharmaceuticals may impose a fine of not less than
100,000 forints and not more than 1 million forints upon any service provider who
failed to fulfill the obligation under Subsection (3). The fine may be imposed
repeatedly during the period of non-compliance.
(5)1 The above-specified fines shall be payable to the account of the imposing
(6) The obligation of temporarily rendering electronic information inaccessible shall
cease after ninety days following the date when ordered.
(7) The government body for pharmaceuticals shall abolish the obligation of
temporarily rendering electronic information inaccessible, before it is terminated, if:
a) the grounds therefor no longer exist; or
b)2 in criminal proceedings opened upon charges filed by the government body for
pharmaceuticals on the grounds of falsification of medicinal or healthcare products
the court ordered in its binding peremptory ruling the obligation of temporarily
rendering electronic information inaccessible or irreversibly rendering electronic
information inaccessible.
(8)3 The government body for pharmaceuticals shall - in order to ensure compliance
with the law and for the protection of patients - publish the name and description of
the website affected by the order - set out in its definitive decision - of temporarily
rendering electronic information inaccessible during the period of execution of the
measure prescribed in the present subtitle.
Liability for Damages in Connection with Investigational Medicinal

Products or the Administration of Medicinal Products and Liability for
Violations of Rights Relating to Personality4
Section 215
(1) If, during the clinical trial of an investigational medicinal product, or as a
consequence thereof, a natural person suffers health impairment, the injured person,
or in the event of death, his/her family member provided for in the Civil Code, shall
be paid restitution by:
a)6 the sponsor of the trial carried out in accordance with an investigation program
approved by the authority which has authorized the clinical trials;
b)7 the sponsor of the trial if the death, disability or severe health impairment
occurred in consequence of the sponsor withholding any information of knowledge
from the authority which has authorized the clinical trials;
c) the authority which has authorized the clinical trials, if the death, disability or
severe health impairment occurs in consequence of the specifications issued by such
authority;
d) the institution carrying out the clinical trials in the event of any deviation from
the investigation program approved by the authority which has authorized the clinical
trials, and the health impairment occurs in consequence thereof;
or shall be compensated for damages linked to death, disability or severe health
impairment.
(2) In respect of liability stemming from the application of medicinal products:
a) for restitution payable in connection with death, disability or severe health
impairment, and
1 Established by Section 77 of Act CLXVIII of 2020, effective as of 1 January 2021.

2 Amended by Section 17 of Act CXVIII of 2018.
3 Amended by Paragraph i) of Section 255 of Act L of 2017.
b) for compensatory damages for loss of property under Paragraph a),

the provisions of the Civil Code on restitution and product liability shall apply subject
to the exceptions set out in Subsection (4).
(3) Where death, disability or severe health impairment results from the proper
application of a medicinal product, and in the case of damage caused by defective
products as provided for in the Civil Code, Subsection (2) of Section 2:52 and Section
6:555 of Act V of 2013 of the Civil Code shall apply.
(4) Where a medicinal product was used in response to the suspected or confirmed
spread of pathogenic agents, toxins, chemical agents or nuclear radiation in
possession of authorization by the government body for pharmaceuticals granted
according to Section 6 or Subsection (2) of Section 7, the State shall compensate
such injured party or the person who suffered loss, or in the case of death, his/her
dependent relative. The provisions of Section 6:564 of the Civil Code shall apply
mutatis mutandis to the mode and measure of indemnification.
(5) For the purposes of this Section ‘dependent relative’ shall mean a person
supported by the injured party or the person who suffered loss pursuant to statutory
provision or contract.
Specific Provisions Relating to Active Substances and Excipients1
Section 222
(1) The manufacture, import and distribution of active substances shall comply with
good manufacturing practice and good distribution practices for active substances,
and the manufacture of excipients shall be in compliance with the principle of good
manufacturing practice for excipients, in accordance with the Decree on the
Personnel and Infrastructure Requirements for the Manufacture of Medicinal
Products for Human Use.
(2) The importers, manufacturers and distributors of active substances having a
registered office or branch in the territory of Hungary shall notify the data specified
in the Decree on the Personnel and Infrastructure Requirements for the Manufacture
of Medicinal Products for Human Use to the government body for pharmaceuticals at
the latest sixty days before the date of taking up the pursuit of their activities.
(3) Where this is deemed necessary by the government body for pharmaceuticals on
account of the risks related to a given active substance, it shall inform the applicant
within fifteen days of receipt of the notification that an inspection will be carried out,
the activity shall not begin before the government body for pharmaceuticals has
notified the applicant that he may commence the activity.
(4) If within the time limit specified in Subsection (3) hereof the government body
for pharmaceuticals has not notified the applicant that an inspection will be carried
out, or has notified the applicant after the inspection that he may commence the
activity, it shall enter the information provided in accordance with Subsection (2) of
this Section in the Union database managed by the European Medicines Agency. If
the government body for pharmaceuticals carried out an inspection under this
Section, it shall decide within sixty days after the notice of inspection whether or not
to authorize the commencement of the activity referred to in Subsection (1) hereof.
(5)3 In the event of any changes in the information entered according to Subsection
(4), the provisions of Subsections (2)-(4) shall apply.
Brokering of Medicinal Products4

Section 231
(1) Persons brokering medicinal products shall have a permanent address in the
EEA, and shall be registered by the competent authorities of the State where the
permanent address is located.
(2) The detailed regulations concerning the registration of brokers of medicinal
products and relating to brokering shall be laid down in specific other legislation.
Patients' Rights in Connection with the Use of Medicinal Products
Section 24
(1) In respect of patients' rights related to medicinal products the provisions of the
Health Care Act pertaining to patients' rights shall be applied with the additions set
forth in Subsection (2).
(2) When dispensing any medicinal product that is not subject to medical
prescription at the users (patients) request (hereinafter referred to as
"self-medication") pharmacists shall be required to provide prudent information
concerning:2
a) the therapeutic value and any potential side effects of such product;
b) interaction with other medicaments when taking more than one at the same
time;
c) the need for medical attention or assistance if deemed appropriate in his
judgement based upon the health of the user (patient);
d) any available substitutes and the price of the medicinal product.
General Provisions Relating to the Use of Medicinal Products
Section 25
(1)3 Medicinal products may be prescribed in accordance with Section 129 of Act
CLIV of 1997 on Health Care - with the exceptions set out in this Act and in the
decree implementing it - in accordance with the indications referred to in the
summary of product characteristics as approved in the marketing authorization, or in
the Catalogue of Standard Prescriptions where applicable. Medicinal products may
be prescribed by any doctor or dentist (hereinafter referred to collectively as
“doctor”) who is qualified to engage in activities subject to a doctor’s diploma and
who has an official stamp for authorization as laid out in specific other legislation, to
prescribe medicinal products.

2 Amended on the base: of paragraph (10) Section 73 of Act CVI of 2008. In force: as of 01. 01.
2009.
3 Established: by paragraph (1) Section 23 of Act XXVIII of 2008. In force: as of 01. 07. 2008.
(2)1 Any medicinal product that has been authorized for marketing in a country
other than in the States which are parties to the EEA Agreement may be used for a
medicinal purpose in exceptional cases if justified by patient care interests deserving
special consideration, and if it has been authorized by the government body for
pharmaceuticals in accordance with the requirements set out in specific other
legislation. Any medicinal product that has been authorized for marketing in any of
the States which are parties to the EEA Agreement may be used for a medicinal
purpose if it has been notified to the government body for pharmaceuticals in
accordance with the provisions of specific other legislation. Patient care interests
deserving special consideration shall be determined in terms of safety and efficacy of
the therapeutic procedure following consultation with the competent advisory board
where deemed necessary.
(2a)2 By way of derogation from Subsection (2), for the purposes of this Act,
patient care interests deserving special consideration shall be considered to exist
during the public health crisis provided for in Act CLIV of 1997 on Health Care in
administrative proceedings conducted in connection with any disease underlying or
directly related to the public health crisis (hereinafter referred to as “disease”), and
relevant to dealing with the public health crisis.
(2b)3 If the conditions set out in Subsection (2a) are met, at the request of the
body responsible for managing the central healthcare reserve the government body
for pharmaceuticals may temporarily authorize - for a specific duration - access to,
and the application or donation of, a medicinal product authorized for marketing in a
country other than a state that is a party to the EEA Agreement, for the purpose of
blocking the suspected or confirmed spread of the disease, if the product is deemed
to be of appropriate quality based on the assessment already completed and where
the risk-benefit balance is considered to be favorable for therapeutic value.
Authorization may be granted for a fixed period of up to six months, and it may be
extended by up to six additional months on a duly justified basis.
(2c)4 In the authorization provided for in Subsection (2b), according to the
relevant government decree:
a) the chief medical officer shall be designated as a specialist authority with
regard to specific issues, and
b) certain provisions of the Government Decree on the Authorization of the
Marketing and Manufacture of Medicinal Products for Human Use relating to
evaluation and authorization shall apply.
(2d)5 The procedure for the supply of the medicinal product authorized in
accordance with Subsection (2b) shall be established by the body responsible for
managing the central healthcare reserve.
(2e)6 If the conditions set out in Subsection (2) are met, in accordance with
Subsections (2f)-(2h), at the request of the body responsible for managing the central
healthcare reserve the government body for pharmaceuticals may authorize, for the
purpose of blocking the suspected or confirmed spread of the disease, the
importation, donation, disbursement to patients and use of a medicinal product made
available to patients or authorized for use by patients:
a) in a state that is party to the EEA Agreement or in a state that is not a party to
the EEA Agreement whose laws are considered equivalent to Hungarian registrations
applicable to clinical trials and/or the manufacture of pharmaceutical products,
b) in the United Kingdom of Great Britain and Northern Ireland, or
c) in at least three states, including at least one European Union or European
Union candidate country.
1 Established by Section 90 of Act CLXXVI of 2011. Amended by Paragraph c) of Section 48 of Act
CCXXIV of 2015.
2 Enacted by Section 239 of Act XCIX of 2021, effective as of 1 December 2021.
(2f)1 Pursuant to Subsection (2e), with the exception of authorization under

Subsection (2g), authorization may be granted for a vaccine if the medicinal product
has already been used for at least one million persons. This circumstance shall be
confirmed by the minister in charge of foreign policies.
(2g)2 The government body for pharmaceuticals may grant authorization under
Subsection (2e) in accordance with Subsection (2b), or on the basis of or by
recognition of an authorization granted in the given state.
(2h)3 Under Subsection (2e), the government body for pharmaceuticals may grant
authorization for a fixed period of up to one year, and it may be extended by up to
one additional year on a duly justified basis. The government body for
pharmaceuticals shall monitor compliance with the conditions for authorization on an
ongoing basis. Having regard to Subsections (3) and (4) of Section 10, the
authorization shall, where appropriate, provide for the provisions set out in
Subsection (5) of Section 5 as well as pharmacovigilance requirements.
(2i)4 The Government may prescribe additional conditions for the use of a
medicinal product authorized under Subsections (2b) and (2h).
(3) The detailed regulations on the prescription of medicinal products by doctors
are laid down in specific other legislation.
(4) Donations of medicinal products may be exported, or may be imported into and
used in the territory of Hungary under the following conditions:5
a)6 with respect to any medicinal product that has been authorized for marketing in
a country other than in the States which are parties to the EEA-Agreement,
exportation and importation must be authorized by the government body for
pharmaceuticals;
b)7 with respect to any medicinal product that has been authorized for marketing in
any of the States which are parties to the EEA-Agreement, exportation and
importation must be notified to the government body for pharmaceuticals.
(5)8 Where any defect in quality is suspected the government body for
pharmaceuticals may proceed to ban the use of the medicinal product in Hungary
within three days, or shall notify the competent authority of the country to which the
medicinal product was exported.
(6)9 Medicinal product may be prescribed and used otherwise than for the
authorized indications contained in the summary of product characteristics
(hereinafter referred to as “prescription for an unauthorized indication”), only if:
a) treatment of a patient with another authorized medicinal product is not possible
or unsuccessful according to the summary of product characteristics, and based on
the experimental evidence defined in specific other legislation, administering the
medicinal product for an unauthorized indication offers the potential of successful
treatment, or to improve or stabilize the patient’s condition;
b) the medicinal product in question is authorized for distribution in the Republic of
Hungary or in another country; and
c) 10 under the relevant conditions set out in specific other legislation the doctor
specializing in the specific therapeutic area

5 Amended: by subparagraph b) Section 96 of Act CLXXVI of 2011. In force: as of 1. 01. 2012.
2007.
2007.
2007.
9 Enacted: by paragraph (2) Section 23 of Act XXVIII of 2008. In force: as of 01. 07. 2008.
10 Established by Subsection (1) of Section 340 of Act LVIII of 2020, effective as of 18 June 2020.
ca)1 has requested individual authorization from the government body for
pharmaceuticals for using a medicinal product for an unauthorized indication for a
specific patient, and the government body for pharmaceuticals has granted such
authorization and notified the physician thereof through the employer healthcare
service provider, or
cb) has notified the use of a medicinal product for an unauthorized indication for a
specific patient to the government body for pharmaceuticals in the cases provided for
in Subsections (6d)-(6h).
(6a)2 In addition to what is contained in Subsection (6), a medicinal product may be
prescribed and/or used for an unauthorized indication if:
a) access to a medicinal product with marketing authorization for a specific
indication is inhibited to an extent where it would likely to delay the treatment
prescribed for the patient, hence causing disproportionately great risk of irreversible
health impairment, or
b) the risk/benefit balance of the medicinal product prescribed for an unauthorized
indication is better than that of the medicinal product with marketing authorization
for a specific indication,
and based on the experimental evidence defined in the relevant legislation,
administering the medicinal product for an unauthorized indication offers the
potential of successful treatment, and/or to improve or stabilize the patient’s
condition, and the conditions set out in Paragraphs b)-c) of Subsection (6) are
satisfied.
(6b)3 The application for authorization under Paragraph c) of Subsection (6), and/or
notification may be submitted on paper as well.
(6c)4 In proceedings for authorization under Subparagraph ca) of Paragraph c) of
Subsection (6) the government body for pharmaceuticals shall communicate its
decision to the healthcare service provider by way of electronic means in accordance
with the Act on the General Rules for Trust Services for Electronic Transactions.
(6d)5 By way of derogation from Subparagraph ca) of Paragraph c) of Subsection
(6) and from Subsection (6a), a medicinal product may be prescribed and/or
administered off label in the cases provided for in Subsections (6e)-(6h), in the case
of medicinal products contained in the recommendation for off-label prescription
subject to notification of the government body for pharmaceuticals.
(6e)6 The government body for pharmaceuticals may - upon request or ex officio -
give recommendation following consultation with the competent advisory board for
specific patient population in relation to the off-label prescription of a specific active
substance or preparation (for the purposes of this Section hereinafter referred to as
“recommendation for off-label prescription”). In giving a recommendation for
off-label prescription, the government body for pharmaceuticals shall take into
consideration
a) the nature of the therapeutic area and the indications shown in the summary of
product characteristics of medicinal products covered by marketing authorization for
use in the given therapeutic area, and
b) the latest trade and scientific knowledge relating to the available therapeutic
solutions and therapeutic indications, and relevant clinical trial results.
(6f)7 The content requirements for applications for recommendation for off-label
prescription shall be laid down in a ministerial decree adopted under authorization
provided for in Paragraph g) of Subsection (5) of Section 32.

3 Enacted by Section 37 of Act CXXI of 2019. Amended by Paragraph a) of Section 343 of Act LVIII
of 2020.
4 Enacted by Section 37 of Act CXXI of 2019. Amended by Paragraph b) of Section 343 of Act LVIII
of 2020.
5 Enacted by Subsection (2) of Section 340 of Act LVIII of 2020, effective as of 18 June 2020.
(6g)1 The government body for pharmaceuticals shall publish recommendations for
off-label prescription on its website. A recommendation for off-label prescription shall
not affect the treating doctor’s responsibility for what is contained in Paragraph a) of
Subsection (6), with particular regard to the condition of the patient concerned, any
concomitant disease the patient may have, and other specific factors indicated in the
recommendation for off-label prescription.
(6h)2 In the case defined in the recommendation for off-label prescription, the
treating doctor shall report to the government body for pharmaceuticals the off-label
prescription, and/or use subsequently, by the deadline or in the frequency specified
in the recommendation for off-label prescription, at least by 31 January and 31 July
each year. The report may be made collectively for more than one patient of the
treating doctor. The recommendation for off-label prescription may offer additional
factors as regards the content of the report.
(7)3 If the summary of product characteristics of the marketing authorization of a
medicinal product contains contra-indications, it may not be prescribed for an
unauthorized indication.
(8)4 The government body for pharmaceuticals shall adopt a decision for the issue
of an authorization under Subparagraph ca) of Paragraph c) of Subsection (6) and
Subsection (6a) within eight days following the date of receipt of the application - or
immediately, in any event within not more than three days in urgent cases - following
consultation with the trade organization if necessary.
(9)5 The regulations for prescriptions of medicinal products for unauthorized
indications in cases of emergency are laid down in specific other legislation.
(10)6 The doctor shall provide a copy of the authorization referred to in Subsection
(8), or the information prepared based on the recommendation for off-label
prescription in the cases under Subsections (6d)-(6h) to the patient before starting to
apply the medication, and the patient shall verify receipt and consent for treatment
with the medicinal product administered within the framework of off-label
prescription by his/her signature. The doctor shall attach this certificate of receipt
and the patient’s consent to the patient’s medical file.
(11)7 The government body for pharmaceuticals shall keep records of the medicinal
products prescribed under Subsections (6)-(6h) with a view to monitor the patient’s
condition and the efficacy of the medicinal product, where these records are to
contain the doctor’s name and the serial number of his seal, the patient’s name, date
of birth and TAJ number, the name of the medicinal product, the active substance,
strength, pharmaceutical form and packaging, and a description of the indication for
which the doctor wishes to prescribe the medicinal product in question, including the
proposed dosage and duration of treatment.
(12)8 The detailed regulations concerning the applications, and/or notifications
mentioned in Subsections (6)-(6a), the authorizations referred to in Subsection (8)
and the information to be provided to patients under Subsection (10) are laid down in
specific other legislation.
(13)9 The proceedings under Subsections (2), (6), (6a) and (6h) shall be exempt
from administrative service fees.
7 Enacted by Subsection (2) of Section 23 of Act XXVIII of 2008. Amended by Paragraph g) of
Section 95 of Act CLXXVI of 2011, Paragraph c) of Section 343 of Act LVIII of 2020.
8 Enacted by Subsection (2) of Section 23 of Act XXVIII of 2008. Amended by Paragraph h) of
Section 95 of Act CLXXVI of 2011, Paragraph d) of Section 343 of Act LVIII of 2020.
9 Enacted by Subsection (1) of Section 44 of Act XXXIV of 2016. Amended by Paragraph e) of
Section 343 of Act LVIII of 2020.
(14)1 By way of derogation from Subsections (2), (6), (6a) and (6h) a medicinal
product may be used in an emergency rescue operation as decreed by the minister in
charge of the healthcare system.
Section 25/A2
Section 25/A3
(1) The government body for pharmaceuticals shall authorize the manufacture of
any advanced therapy (novel) medicinal product that does not have the marketing
authorization under Point 29 of Section 1, which is prepared on a non-routine basis
according to specific quality standards, and used in a hospital under the exclusive
professional responsibility of a medical practitioner, in order to comply with an
individual medical prescription for a custom-made product for a specific patient
[hereinafter referred to as “custom-made advanced therapy (novel) medicinal product
prepared in a hospital”].
(2) The government body for pharmaceuticals shall publish on its website notices on
its decisions relating to the preparation of custom-made advanced therapy (novel)
medicinal products in hospitals.
(3) The authorization procedure shall be exempt from administrative service fees.
Fees Charged for Authorization Procedures Relating to Medicinal Products4
Section 25/B5
(1) Authorization and modification procedures and other proceedings - shown in

Schedule No. 1 - relating to the manufacturing, placing on the market and
distribution of medicinal products for human use, the continuation of the marketing
authorization, the wholesale distribution of medicinal products, the reclassification of
therapeutic substances and preparations which are not classified as medicinal
products, parallel imports, clinical trial of investigational medicinal products, the
application of principles of good laboratory practice shall be subject - with the
exception set out in Subsection (2) - to an administrative service fee (hereinafter
referred to as “fee”) as specified in Schedule No. 1, payable by the person requesting
the opening of the proceedings or by the applicant of the authorization, or an annual
renewal fee for the continuation of the marketing authorization as specified in
Schedule No. 1.
(2)6 Proceedings for the authorization of non-commercial clinical trials are free of
charge.
(2a)7 The administrative service fee and renewal fee referred to in Subsections (1)
and (5) need not be paid in the case of proceedings related to medicinal products
having preferential status under the Medicine Act.
(2b)8 In the case provided for in Subsection (1c) of Section 21 of the Medicine Act,
the marketing authorization holder is required to pay the administrative service fee
and renewal fee referred to in Subsections (1) and (5).
1 Enacted by Subsection (2) of Section 44 of Act XXXIV of 2016. Amended by Paragraph e) of

Section 343 of Act LVIII of 2020.
2 Repealed with preceding subtitle: by subparagraph e) Section 56 of Act CLXXIII of 2010. No
3 Established by Section 26 of Act LIX of 2017, effective as of 1 July 2017.
6 Amended by Paragraph a) of Section 110 of Act CI of 2021.
(2c)1 If the applicant indicates in the application for marketing authorization for a
medicinal product his intention to request preferential status from the health
insurance administration agency after the marketing authorization is issued, the
government body for pharmaceuticals shall refund to the marketing authorization
holder the administrative service fee such holder has paid, if the health insurance
administration agency grants the preferential status requested.
(2d)2 As regards any small or medium-sized enterprise covered by Act XXXIV of
2004 on Small and Medium-sized Enterprises and the Support Provided to Such
Enterprises that is authorized to manufacture medicinal products in Hungary, and
said authorization is not limited to packaging or batch release exclusively, by way of
derogation from Subsection (1) such small or medium-sized enterprise shall be
required to pay 50 per cent of the administrative service fee specified in Annex 1 for
the proceedings provided for in Annex 1.
(3) The fee charged for the procedures listed in Points I, II and III/A-G of Schedule
No. 1 shall be paid separately for each clinical trial and each medicinal product.
(4) The fees shown in Schedule No. 1 shall be determined in consideration of the
following:
a) where a homeopathic medicine contains - apart from the homeopathic component
- other non-homeopathic (allopathic) components as well, the marketing authorization
fees relating to allopathic preparations shall be applied;
b) where a medicinal product is placed in the market as a homeopathic product,
that is made by such process and claiming to have therapeutic efficacy, it shall be
treated as a non-homeopathic medicine for reasons of assessment of the fee.
(5) In the event of any changes in the particulars contained in the authorizations
referred to in Subsection (1), or in the particulars of the marketing authorizations of
specific medicinal products, each and every request for modification, independent
from any other such request shall be subject to procedural fees separately for each
pharmaceutical form or strength, regardless of whether the application is submitted
individually or together with other requests pertaining to more than one medicinal
product. As regards the modification of the authorization of a clinical trial, each and
every request - described by law - lodged independently for modification as to content
shall be subject to procedural fees separately, regardless of whether the application
is submitted individually or together with other requests pertaining to more than one
clinical trial.
(6) The fee shall be paid at the time the application is submitted, whereas the
annual renewal fee shall be paid by 31 January of the given year to the government
body for pharmaceuticals in the manner decreed by the minister in charge of the
healthcare system.
(6a)3 The government body for pharmaceuticals shall suspend further distribution
of a medicinal product if the marketing authorization holder failed to comply with the
obligation to pay the renewal fee applicable pursuant to Subsection (1) by the
deadline specified in Subsection (6). Where suspension is ordered on account of
non-payment of the renewal fee it shall not affect the medicinal products already
delivered to wholesalers of medicinal products and healthcare service providers
before the suspension.
(6b)4 The suspension provided for in Subsection (6a) may be lifted following
payment of the marketing authorization renewal fee.

3 Enacted by Section 27 of Act CLXXII of 2016, effective as of 1 January 2017.
(7)1 With the exceptions set out in other legislation, the proceeds from the fees
shall constitute revenue for the government body for pharmaceuticals, and the
special authorities participating in the proceedings as required by law. The records
and accounting of such fees shall fall within the scope of the legislation governing the
bookkeeping obligations of the central budget. The government body for
pharmaceuticals and the special authorities shall be entitled to a part of the revenues
from fees in the percentage decreed by the minister in charge of the healthcare
system.
(8) As regards the procedures for which the fees are charged, and the persons
liable for the payment of such fees, Subsections (2)-(3) of Section 28 of Act XCIII of
1990 on Duties (hereinafter referred to as “Duties Act”) and the first sentence of
Subsection (1) of Section 31 of the Duties Act shall apply, respectively, with the
exception that any reference made in the Duties Act to duties shall be understood as
fees.
(9)2 During the public health crisis the government body for pharmaceuticals shall
not examine proof of payment of the administrative service fee provided for in this
Act as a precondition in assessing the application if:
a) the application is for an official decision required for controlling the wide-spread
human epidemic during the public health crisis, for reasons of providing care, or
b) the government body for pharmaceuticals gives an official decision for a fixed
term of six months, in relation to the objective set out in Paragraph a).
Compassionate Use of Medicinal Products, and/or Use of Medicinal Products

Before Placed on the Market3
Section 25/C4
(1)5 Within the framework of a compassionate use program, investigational

medicinal products and medicinal products which do not have a marketing
authorization - including the medicinal products shown in the indication applied for
which do not have a marketing authorization (in respect of this Section hereinafter
referred to collectively as “medicinal product”) may be made available by
authorization of the government body for pharmaceuticals for reasons of patient care
interests deserving special consideration if:
a) the medicinal product affected
aa) has already been tested by at least a phase II clinical trial in a country whose
laws are considered to be equivalent to the Hungarian regulatory system applicable
to clinical trials, or such clinical trial is in progress, or
ab) is undergoing marketing authorization procedures in Hungary or in a country
referred to in Subparagraph aa);
b) use of the medicinal product is requested by a doctor for the treatment of a
patient who has suffered a life-threatening or debilitating medical condition;
c) the patient or his legal representative has given his written consent after being
informed of the risks, among others, of compassionate use of medicinal products; and
d)6 the manufacturer of the medicinal product has given consent for compassionate
use and agrees to supply the medicinal product free of charge for the entire duration
of the treatment, or until admission of such medicinal product into the social security
subsidy system if this occurs earlier, and guarantees its quality in accordance with
good manufacturing practice;
1 Established by Section 21 of Act CCIII of 2013, effective as of 1 January 2014.
2 Enacted by Section 341 of Act LVIII of 2020, effective as of 18 June 2020.
3 Enacted by Section 56 of Act LXXVII of 2015. Amended by Point 16 of Section 109 of Act CI of
2021.
4 Enacted by Section 56 of Act LXXVII of 2015, effective as of 1 January 2016.
e)1 the compassionate use of medicinal products does not manifest in unlawful
commercial practices under the Medicine Act.
(2) In the application for the authorization the treating doctor is to justify and give
reasons for the compassionate use of the medicinal product in question, demonstrate
the treatment process, and shall provide for the proper documentation of all events
that may have an impact on patient safety and for reporting to the government body
for pharmaceuticals.
(2a)2 Before making a decision, the government body for pharmaceuticals shall
check whether the conditions under Paragraphs a)-d) of Subsection (1) are satisfied
and whether Paragraph e) of Subsection (1) applies.
(3) The government body for pharmaceuticals shall keep records on its decisions
relating to compassionate use of medicinal products with a view to monitor on an
ongoing basis the patient’s condition and the efficacy of the medicinal product, where
these records are to contain the doctor’s name and the serial number of his seal, the
patient’s name, date of birth and TAJ number, the name of the medicinal product, the
active substance, strength, pharmaceutical form and packaging, and a description of
the indication for which the doctor wishes to prescribe the medicinal product in
question, including the proposed dosage and duration of treatment.
(4) The government body for pharmaceuticals shall publish notices on its decisions
relating to the compassionate use of medicinal products on its website.
(5) The government body for pharmaceuticals shall adopt a decision for the issue of
authorization within twenty-one days following the date of receipt of the application -
or immediately, in any event within not more than three days in urgent cases -
following consultation with the competent trade organization if necessary.
(6) The authorization procedure relating to compassionate use shall be exempt from
administrative service fees.
(7)3 Subsections (1)-(6) shall apply also where the medicinal product to be used has
already been authorized in a centralized procedure provided for in Regulation (EC)
No. 726/2004 of the European Parliament and of the Council of 31 March 2004 laying
down Community procedures for the authorization and supervision of medicinal
products for human and veterinary use and establishing a European Medicines
Agency, however, it has not yet been placed on the market in the territory of the
European Union.
(8)4 A medicinal product may be administered under compassionate use of
medicinal products for reasons of epidemic control or in the case of patient care
interests deserving special consideration in consequence of the public health crisis
provided for in Act CLIV of 1997 on Health Care, by way of derogation from
Subsections (1), (2) and (7) indicated below, subject to authorization by the
government body for pharmaceuticals if the expected risk-benefit balance relying on
documented clinical results available from the use of the medicinal product in
question is favorable:
a) if the condition provided for in Subparagraph aa) of Paragraph a) of Subsection
(1) can be satisfied with a medicinal product listed in the recommendation or
program of the European Medicines Agency or World Health Organization in respect
of the given indication,
b) Paragraph b) of Subsection (1) applies with the derogation that the applicant
may be a healthcare service provider or - if the healthcare service provider or
physician responsible for care is indicated - a sponsor, and the application can be
submitted for a pre-determined patient population or program as well,
1 Enacted by Subsection (1) of Section 46 of Act CCXXIV of 2015, effective as of 1 January 2016.
2 Enacted by Subsection (2) of Section 46 of Act CCXXIV of 2015, effective as of 1 January 2016.
3 Enacted by Section 38 of Act CXXI of 2019, effective as of 1 January 2020.
4 Enacted by Section 342 of Act LVIII of 2020, effective as of 18 June 2020.
c) under a reasoned request, the government body for pharmaceuticals may - in

exceptional cases - dispense with Paragraph d) of Subsection (1) if obtaining the
consent of the manufacturer of the medicinal products, or obtaining a commitment
for supplying the medicinal product free of charge is likely to entail delay or
unreasonable difficulties such that would render the issue of the authorization
impossible,
d)1 the requirement of justification referred to in Subsection (2) may be satisfied by
the sponsor of the clinical trial provided for in Subparagraph aa) of Paragraph a) of
Subsection (1) as well, and
e) the condition under Subsection (7) shall be considered satisfied if the medicinal
product to be used has not yet been placed on the market in the territory of Hungary,
and the exception provided for in Paragraph c) is not applied.
Use of Ex Tempore Radiopharmaceutical Products2
Section 25/D3
(1) Ex tempore radiopharmaceutical products may be used for medical purposes if:
a) justified by patient care interests deserving special consideration or if the
risk/benefit balance thereof is better than that of the medicinal product with
marketing authorization for a specific indication, and treatment of a patient
according to Subsection (2) or (6) of Section 25 is not possible;
b) manufactured subject to special medical prescription, with ingredients and in
quality specified by the treating doctor, specifically for a patient in his care;
c) administered under the sole responsibility of the treating doctor;
d) production has been authorized by the government body for pharmaceuticals
according to the conditions defined by the relevant legislation.
Miscellaneous Provisions
Section 26
(1) Manufacturers and wholesalers of medicinal products and the operators of
pharmacies shall provide for proper destruction of medicinal products which are no
longer marketable (inadequate quality, expired) in compliance with the provisions set
forth in legal regulations governing environmental protection, and shall partake - in
compliance with the provisions of specific other legislation - in the collection and
disposal of medicinal waste products from the general public. The destruction of
medicinal products classified as narcotic or psychotropic substances shall be
governed in specific other legislation.
(2)4 The provisions for the destruction of medicinal products and the procedures to
be followed, the special safety regulations to be applied for medicinal products
classified as narcotic or psychotropic substances, and the control and enforcement of
environmental protection requirements shall be decreed by the minister in charge of
the healthcare system.

2 Enacted by Section 19 of Act CLXXXVIII of 2017, effective as of 18 January 2018.
3 Enacted by Section 19 of Act CLXXXVIII of 2017, effective as of 18 January 2018.
4 Amended: by subparagraph r) paragraph (4) Section 171 of Act CIX of 2006. In force: as of 01. 01.
2007.
(3)1 The government body for pharmaceuticals shall maintain an official register of
the medicinal products authorized for placing on the market and distribution in
Hungary.
(4)2 The manufacturer's (importer's) prices and retail prices, and the amount of
support of medicinal products authorized for distribution in Hungary with public
financing shall be published according to the provisions laid down in specific other
legislation.
(5)3 The health insurance administration agency and government body for
pharmaceuticals shall post all information that has been published in their official
journals concerning the placing on the market and prescription of medicinal products
and the amount of social security subsidies provided for the various products, on
their official websites as well.
(6)4 The decisions of the government body for pharmaceuticals adopted in
accordance with this Act, or relating to the registration and placing on the market of
therapeutic substances and preparations not classified as medicinal products may not
be appealed; however.
(7)5 The government body for pharmaceuticals shall maintain an official public
register on all therapeutic preparations which are not classified as medicinal
products that have been authorized for marketing in Hungary, containing their name
and the date of authorization.
(8)6
(9)7
(10)8 In the authorization and control procedures provided for in this Act and/or
other legislation adopted by authorization under this Act the client’s statement shall
not be admissible as a substitute for any unavailable evidence.
(11)9 The time periods specified in Directive 2001/83/EC of the European
Parliament and of the Council of 6 November 2001 on the Community code relating
to medicinal products for human use shall not be included in the administrative time
limit in the authorization and control procedures provided for in this Act.
(12)10 In authorization and control procedures provided for in this Act and in other
legislation implemented by authorization of this Act, if the case cannot be reliably
resolved without a decision in another proceeding under the competence of the same
authority that closely relates to the case on hand, the rules on related procedures set
out by the Act on General Public Administration Procedures shall apply, where each
decision shall be made separately.
(13)11 The administrative time limit for administrative proceedings opened ex
officio under this Act and other legislation implemented by authorization of this Act
shall be one hundred ten days.
2007. Amended: by subparagraph i) Section 95 of Act CLXXVI of 2011. In force: as of 1. 01. 2012.
2 Amended: by subparagraph i) Section 95 of Act CLXXVI of 2011. In force: as of 1. 01. 2012.
3 Amended: by subparagraph n) paragraph (2) Section 80 of Act CIX of 2006. In force: as of 01. 01.
2007. Amended: by subparagraph b) paragraph (2) Section 106 of Act CIX of 2006. In force: as of
01. 01. 2007.
4 Established: by Section 24 of Act XXVIII of 2008. In force: as of 01. 07. 2008. Amended: by
Sections 328-329 of Act LVI of 2009. In force: as of 1. 10. 2009.
6 Repealed by Section 256 of Act L of 2017, effective as of 1 January 2018.
7 Repealed by Section 20 of Act XXX of 2020, effective as of 1 July 2020.
8 Enacted by Subsection (5) of Section 254 of Act L of 2017. Amended by Point 20 of Section 109 of
Act CI of 2021.
9 Enacted by Subsection (5) of Section 254 of Act L of 2017, effective as of 1 January 2018.
(14)1 The government body for pharmaceuticals shall have authority to suspend
authorization proceedings specified in this Act and in legislation implemented by
authorization of this Act where the decision concerning the incidental question lies
with another body, or if the case cannot be reliably resolved without a decision in
another proceeding under the competence of the same authority that closely relates
to the case on hand.
Section 272
Electronic communication shall be carried out - with the exceptions set out in
Subsections (1)-(6a) of Section 25 of this Act and in Subsections (2)-(3) of Section 3 of
the legislation on the pursuit of the business of wholesale distribution of medicinal
products in conjunction with the importation of medicinal products - via the IT
systems of the government body for pharmaceuticals and the government body in
charge of the healthcare system in connection with the regulatory proceedings of the
government body for pharmaceuticals and the government body in charge of the
healthcare system concerning medicinal products, investigational products and
products registered as therapeutic substances and preparations which are not
classified as medicinal products, and concerning laboratories and individual test sites
operating in conformity with the principles of good laboratory practice.
Section 283
A list of the substances which are classified as dangerous psychotropic substances,

treated as narcotic drugs, by means other than Lists I and II of the Annex to the
Convention on Psychotropic Substances signed in Vienna on 21 February 1971 and
promulgated by Law-Decree No. 25 of 1979, is contained in Annex 2.
Section 294
Homeopathic medicinal products with therapeutic indication, authorized before 1

January 2004 may be marketed after 1 July 2020 if in compliance with Directive
2001/83/EC of the European Parliament and of the Council and the regulations on the
transposition thereof relating to placing such medicinal products on the market.
Section 305
Section 316
Closing Provisions
Section 32
(1) This Act shall enter into force on 30 October 2005.
1 Enacted by Section 104 of Act CI of 2021, effective as of 29 June 2021.

2 Established by Section 79 of Act CLIV of 2009. Amended by subparagraph j) Section 95 of Act
CLXXVI of 2011, Section 45 of Act CXXI of 2016.
4 Established by Section 15 of Act CXVIII of 2018. Amended by Section 1 of Act CXI of 2019.
5 Repealed: by subparagraph j) paragraph (1) Section 34 of Act XCVII of 2006. No longer in force:
as of 01. 04. 2007.
6 Repealed: by subparagraph f) paragraph (3) Section 83 of Act XCVIII of 2006. No longer in force:
as of 29. 12. 2006.
(2)1
(3)2
(4) The Government is hereby authorized to decree:
a)3 the detailed conditions for the manufacture, placing on the market, retail and
wholesale distribution of medicinal products classified as narcotic and psychotropic
substances, for the importation into and exportation of such medicinal products from
the territory of Hungary, furthermore, their purchase and use for scientific purposes,
the procedures for issuing the authorization for such activity, the contents of the
register - other than personal data - of authorized operators, and the detailed
procedural rules for operating the register, furthermore, the sanctions for any
infringement of the provisions of the relevant legislation or of the resolutions adopted
by the competent authorities;
b) the sphere of application and procurement of medicinal products classified as
narcotic or psychotropic within the meaning of international conventions for scientific
purposes;
c) the amount of penalty to be imposed for any violation of the public service
obligation conferred in this Act for the supply of medicinal products;
d)4 the designation of the government body or bodies for pharmaceuticals;
e)5 in connection with new psychoactive substances:
ea)6
eb) the detailed regulations for classification as a new psychoactive substance, and
for the risk assessment of such new psychoactive substances,
ec) the designation of an expert body to carry out prior scientific evaluations upon
notifications,
ed) the detailed conditions for activities with new psychoactive substances, the
rules for the submission of applications for the authorization of such activities and for
the authorization procedure, and
ee) the sanctions for any infringement of the provisions of the relevant legislation or
of the resolutions adopted by the competent authorities;
f)7 the manufacturing and the distribution authorization procedures for medicinal
products for human use;
g)8 the authorization procedures for the individual prescription and the use of
medicinal products for human use;
h)9 the authorization procedures for engaging in the wholesale distribution of
medicinal products in conjunction with the importation of medicinal products;
i)10 the detailed regulations for the supervision of laboratories contracted for
testing medicinal products for reasons of safety;
j)11 further conditions for the use of medicinal products authorized under
Subsections (2b) and (2h) of Section 25.
(5) The minister in charge of the healthcare system is hereby authorized to decree:
12
1 Repealed: by point 819 Section 2 of Act LXXXII of 2007. No longer in force: as of 1. 07. 2007.
2 Repealed by Point 1 of Section 184 of Act LXVII of 2016, effective as of 17 July 2016.
Amended: by subparagraph a) Section 95 of Act CLXXVI of 2011. In force: as of 1. 01. 2012.
4 Enacted: by subparagraph (1) Section 106 of Act CIX of 2006. In force: as of 01. 01. 2007.
6 Repealed by Section 94 of Act CXI of 2014, effective as of 1 January 2015.
12 Amended: by subparagraph r) paragraph (4) Section 171 of Act CIX of 2006. In force: as of 01. 01.
2007.
a)1 the conditions for the issue of marketing authorization for medicinal products,
the procedure for the removal of medicinal products from circulation, and for the
suspension of distribution rights;
b) the various types of the medicinal products falling within the scope of this Act;
c)2 the detailed regulations relating to the application of the principles of good
laboratory practice, and for the operation of laboratories contracted for testing
medicinal products for reasons of safety;
d) the conditions for conducting clinical trials, the documents required for the
authorization of clinical trials, the detailed regulations for the authorization
procedure, the proceedings of the research ethics committee, and the professional
requirements for the conduct and control of clinical trials;
e) the conditions for the change of classification of therapeutic substances and
preparations which are not classified as medicinal products to be classified as such;
f) the detailed regulations for engaging in the wholesale distribution of medicinal
products in conjunction with the importation of medicinal products;
g)3 the regulations for the prescription of medicinal products by doctors for
unauthorized indications in cases of emergency, and for any shortage in supplies of
medicinal products;
h) the rules for the institutional supply of medicinal products;
i)4 the qualification requirements for the authorized persons participating in the
manufacture of medicinal products and the persons contracted to participate in
activities for the wholesale distribution of medicinal products;
j) the procedures for prescription of medicinal products classified as narcotic and
psychotropic substances, their sale in pharmacies - including storage, records, and
their dispensation from pharmacies -, and for the use of these products in medical
institutions and the records on such usage;
k) the personnel and infrastructure requirements for the manufacture of medicinal
l) the sphere of diagnostic agents which are not used in or on the human body;
m)5 the mandatory use of the Pharmacopoeia and the Catalogue of Prescriptions for
manufacturers and distributors of medicinal products and for doctors and
pharmacists;
n) the regulations relating to the labelling and package leaflets of medicinal
products;6
o) the form and professional requirements for dispensing medicinal products in
pharmacies, and the regulations on consultation by pharmacists;
p) the regulations for the destruction of medicinal products and the procedures to
be followed, the special safety regulations to be applied for medicinal products
classified as narcotic or psychotropic substances, and the control and enforcement of
environmental protection requirements;
q)7 the regulations relating to custom-made advanced therapy medicinal products
prepared in hospitals;
r)8 the formal and content requirements for a doctor’s certificate - prescribed
according to international convention - on medicinal products classified as narcotic or
a psychotropic substance required for the movement of travelers through customs
carrying such medicinal products that are necessary for their medical treatment;

2018.
2018.
4 Established: by paragraph (1) Section 63 of Act LXXIX of 2012. In force: as of 1. 07. 2012.
5 Established: by paragraph (1) Section 43 of Act CLXXXI of 2005. In force: as of 01. 01. 2006.
6 See Decree No. 30/2005 (VIII. 2.) EM.
8 Enacted: by paragraph (3) Section 53 of Act CLXXIII of 2010. In force: as of 1. 01. 2011.
s)1 the inventories required to be maintained, including the active substances, with
a view to ensuring the continued supplies under Subsection (5) of Section 16;
t)2 the provisions relating to pharmacovigilance;
u)3 the rules governing cooperation between the marketing authorization holder,
wholesalers of medicinal products, the administrator of state healthcare, catastrophe
and safety reserves, the government body for pharmaceuticals and the health
insurance administration agency in the interest of control and prevention of any
shortage in the supplies of specific medicinal products;
v)4 the provisions on the brokering of medicinal products;
w)5 the rules concerning good manufacturing practice and good distribution
practices for active substances, and the rules concerning good manufacturing
practice for excipients;
x) 6 the substances and compounds classified as new psychoactive substances;
y)7 the detailed rules relating to compassionate uses of medicinal products and uses
of medicinal products before placed on the market;
z)8 the detailed rules relating to the safety features appearing on the packaging of
medicinal products for human use, including their handling, and the persons
authorized to handle such safety features.
(6)9 The minister in charge of the healthcare system is hereby authorized to decree,
in agreement with the minister in charge of taxation, the types of administrative
service fees, including their amounts and other regulations relating to payment terms
and conditions, payable:
a)10 for the authorization and registration procedures relating to narcotic and
psychotropic substances, and for the issue and amendment of such authorizations;
b)11 for the authorization and registration procedures relating to new psychoactive
substances, and for the issue and amendment of authorizations;
c) 12
d)13 for proceedings relating to certification of the conditions for the manufacture
of products registered as therapeutic substances and preparations which are not
classified as medicinal products for public health and epidemiological considerations,
and for the issue of the certificate;
e)14 for the examination (certification) of a production batch of immunological
products.
4 Enacted: by paragraph (2) Section 63 of Act LXXIX of 2012. In force: as of 1. 07. 2012.
5 Enacted: by paragraph (2) Section 63 of Act LXXIX of 2012. In force: as of 1. 07. 2012.
7 Enacted by Section 57 of Act LXXVII of 2015. Amended by Point 21 of Section 109 of Act CI of
2021.
8 Enacted by Section 16 of Act CXVIII of 2018, effective as of 1 January 2019.
9 Established: by paragraph (2) Section 25 of Act XXVIII of 2008. In force: as of 01. 07. 2008.
2018.
2018.
12 Repealed: by subparagraph e) paragraph (5) Section 51 of Act CIX of 2009. No longer in force: as
of 1. 01. 2010.
13 Enacted: by Section 69 of Act CVI of 2008. In force: as of 01. 01. 2009.
14 Enacted: by Section 69 of Act CVI of 2008. In force: as of 01. 01. 2009.
(7)1 Manufacturers and/or distributors of products registered as therapeutic

substances and preparations which are not classified as medicinal products pursuant
to the decree on the registration and marketing of therapeutic substances and
preparations not classified as medicinal products may apply for having their
preparations - containing any ingredient of plant origin - reclassified as medicinal or
other products until 31 March 2011. Following the entry of this Act into force no
proceedings may be launched for the registration and marketing of any new
therapeutic preparations which are not classified as medicinal products.
(8)2 The conditions for the reclassification of the products under Subsection (7) as
medicinal products shall be established by specific other legislation.
(9)3 Products registered as therapeutic substances and preparations which are not
classified as medicinal products, which may be considered traditional herbal
medicinal products on account of all their specificities and are available in
commercial circulation on 31 March 2011, may be marketed with reference to having
medicinal properties until their expiry date, or until 1 April 2013 at the latest.
(10)4 The minister in charge of the healthcare system is hereby authorized to
decree, in agreement with the minister in charge of taxation, the regulations relating
to the management, registration and distribution of the fees referred to in Section
25/B.
Section 32/A5
Subsection (7) of Section 5, as established by Act CLXXVI of 2011 on the

Amendment of Health Regulations, shall apply to applications submitted after 21 July
2012.
Section 32/B6
The provisions of this Act established by Act L of 2017 on Amendments Relating to

the Implementation of the Act on General Public Administration Procedures and the
Act on the Code of Administrative Procedure (hereinafter referred to as
“Administrative Amendments Act”) shall apply to proceedings opened after the date
of entry into force of the Administrative Amendments Act and to reopened cases.
Section 337
This Act serves the purpose of compliance with:

a) Directive 2001/20/EC of the European Parliament and of the Council of 4 April
2001 on the approximation of the laws, regulations and administrative provisions of
the Member States relating to the implementation of good clinical practice in the
conduct of clinical trials on medicinal products for human use;
b) Directive 2001/83/EC of the European Parliament and of the Council of 6
November 2001 on the Community code relating to medicinal products for human
use;
c) Directive 2004/27/EC of the European Parliament and of the Council of 31 March
2004 amending Directive 2001/83/EC on the Community code relating to medicinal
2 Amended: by paragraph (2) Section 43, subparagraph g paragraph (3) Section 44 of Act CLXXXI of
2005. In force: as of 01. 01. 2006.
3 Established: by Section 43 of Act LXXXI of 2011. In force: as of 1. 07. 2011.
d) Directive 2004/10/EC of the European Parliament and of the Council of 11

February 2004 on the harmonisation of laws, regulations and administrative
provisions relating to the application of the principles of good laboratory practice and
the verification of their applications for tests on chemical substances;
e) Commission Directive (EU) 2017/1572 of 15 September 2017 supplementing
Directive 2001/83/EC of the European Parliament and of the Council as regards the
principles and guidelines of good manufacturing practice for medicinal products for
human use;
f) Commission Directive 2005/28/EC of 8 April 2005 laying down principles and
detailed guidelines for good clinical practice as regards investigational medicinal
products for human use, as well as the requirements for authorisation of the
manufacturing or importation of such products;
g) Directive 2009/53/EC of the European Parliament and of the Council of 18 June
2009 amending Directive 2001/82/EC and Directive 2001/83/EC, as regards
variations to the terms of marketing authorisations for medicinal products;
h) Directive 2010/84/EU of the European Parliament and of the Council of 15
December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on
the Community code relating to medicinal products for human use;
i) Directive 2011/62/EU of the European Parliament and of the Council of 8 June
2011 amending Directive 2001/83/EC on the Community code relating to medicinal
products for human use, as regards the prevention of the entry into the legal supply
chain of falsified medicinal products;
j) Directive 2012/26/EU of the European Parliament and of the Council of 25
October 2012 amending Directive 2001/83/EC as regards pharmacovigilance;
k)1 Commission Delegated Directive (EU) 2019/369 of 13 December 2018 amending
the Annex to Council Framework Decision 2004/757/JHA as regards the inclusion of
new psychoactive substances in the definition of ‘drug’;
l)2 Commission Delegated Directive (EU) 2020/1687 of 2 September 2020 amending
the new psychoactive substance
N,N-diethyl-2-[[4-(1-methylethoxy)phenyl]methyl]-5-nitro-1H-benzimidazole-1-ethanamine
(isotonitazene) in the definition of ‘drug’;
m)3 Commission Delegated Directive (EU) 2021/802 of 12 March 2021 amending
the new psychoactive substances methyl
3,3-dimethyl-2-{[1-(pent-4-en-1-yl)-1H-indazole-3-carbonyl]amino}butanoate
(MDMB-4en-PINACA) and methyl
2-{[1-(4-fluorobutyl)-1H-indole-3-carbonyl]amino}-3,3-dimethylbutanoate
(4F-MDMB-BICA) in the definition of ‘drug’.
Section 344
This Act contains provisions for the implementation of:

a) Regulation (EC) No. 726/2004 of the European Parliament and of the Council of
31 March 2004 laying down Community procedures for the authorization and
supervision of medicinal products for human and veterinary use and establishing a
European Medicines Agency;
b) Regulation (EC) No. 1901/2006 of the European Parliament and of the Council of
12 December 2006 on medicinal products for paediatric use and amending
Regulation (EEC) No. 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and
Regulation (EC) No. 726/2004;
1 Established by Subsection (1) of Section 1 of Act CXII of 2021, effective as of 25 November 2021.
2 Established by Subsection (1) of Section 1 of Act CXII of 2021, effective as of 25 November 2021.
3 Enacted by Subsection (2) of Section 1 of Act CXII of 2021, effective as of 25 November 2021.
c) Regulation (EC) No. 1394/2007 of the European Parliament and of the Council of
13 November 2007 on advanced therapy medicinal products and amending Directive
2001/83/EC and Regulation (EC) No. 726/2004;
d) Commission Regulation (EC) No. 1234/2008 of 24 November 2008 concerning
the examination of variations to the terms of marketing authorisations for medicinal
products for human use and veterinary medicinal products;
e) Council Decision 2013/129/EU of 7 March 2013 on subjecting
4-methylamphetamine to control measures;
f) Council Implementing Decision 2013/496/EU of 7 October 2013 on subjecting
5-(2-aminopropyl)indole to control measures;
g) Commission Delegated Regulation (EU) No. 357/2014 of 3 February 2014
supplementing Directive 2001/83/EC of the European Parliament and of the Council
and Regulation (EC) No. 726/2004 of the European Parliament and of the Council as
regards situations in which post-authorisation efficacy studies may be required;
h) Council Implementing Decision 2014/688/EU of 25 September 2014 on
subjecting 4-iodo-2,5-dimethoxy-N-(2-methoxybenzyl)phenethylamine (25I-NBOMe),
3,4-dichloro-N-[[1-(dimethylamino)cyclohexyl]methyl]benzamide (AH-7921),
3,4-methylenedioxypyrovalerone (MDPV) and
2-(3-methoxyphenyl)-2-(ethylamino)cyclohexanone (methoxetamine) to control
measures;
i) Council Implementing Decision (EU) 2015/1873 of 8 October 2015 on subjecting
4-methyl-5-(4-methylphenyl)-4,5-dihydrooxazol-2-amine (4,4′-DMAR) and
1-cyclohexyl-4-(1,2-diphenylethyl)piperazine (MT-45) to control measures;
j) Commission Delegated Regulation (EU) 2016/161 of 2 October 2015
supplementing Directive 2001/83/EC of the European Parliament and of the Council
by laying down detailed rules for the safety features appearing on the packaging of
medicinal products for human use;
k) Commission Delegated Regulation (EU) 2017/1569 of 23 May 2017
supplementing Regulation (EU) No. 536/2014 of the European Parliament and of the
Council by specifying principles of and guidelines for good manufacturing practice
for investigational medicinal products for human use and arrangements for
inspections;
l) Council Implementing Decision (EU) 2018/1463 of 28 September 2018 on
subjecting the new psychoactive substances
N-phenyl-N-[1-(2-phenylethyl)piperidin-4-yl]cyclopropanecarboxamide
(cyclopropylfentanyl) and
2-methoxy-N-phenyl-N-[1-(2-phenylethyl)piperidin-4-yl]acetamide
(methoxyacetylfentanyl) to control measures.
Section 351
In connection with the draft of Annex 2, the prior notification procedure provided
for in Articles 5-7 of Directive (EU) 2015/1535 of the European Parliament and of the
Council of 9 September 2015 laying down a procedure for the provision of
information in the field of technical regulations and of rules on Information Society
services has been fulfilled.
Section 35/A2
(1) The allowance under Subsection (2d) of Section 25/B shall be treated as de
minimis aid that can be provided under Commission Regulation 1407/2013/EU.

(2) The gross grant equivalent of de minimis aid granted in Hungary in accordance
with Commission Regulation 1407/2013/EU to any enterprise qualified as a single
undertaking (in the application of this Section hereinafter referred to as “aid”) may
not exceed the forint equivalent of EUR 200,000, having regard to Article 3(8) and (9)
of Commission Regulation 1407/2013/EU.
(3) For the grant of de minimis aid, the amount of gross grant equivalent granted in
the fiscal year concerned, as well as during the previous two fiscal years, needs to be
determined.
(4) Save where Article 1(2) of Commission Regulation 1407/2013/EU applies, aid
may not be granted to an enterprise that proposes to use the aid requested under the
exemptions provided for in Article 1(1) of Commission Regulation 1407/2013/EU.
(5) Aid may be cumulated with de minimis public service subsidies granted in
accordance with Commission Regulation (EU) No. 360/2012 of 25 April 2012 on the
application of Articles 107 and 108 of the Treaty on the Functioning of the European
Union to de minimis aid granted to undertakings providing services of general
economic interest up to the relevant ceiling laid down in this Regulation. Aid may be
cumulated with de minimis aid granted in accordance with other de minimis
regulations up to the relevant ceiling provided for in Subsection (3).
(6) De minimis aid shall not be cumulated with State aid in relation to the same
eligible costs or with State aid for the same risk finance measure, if such cumulation
would exceed the highest relevant aid intensity or aid amount fixed in the specific
circumstances of each case by a block exemption regulation or a decision adopted by
the European Commission.
(7) The beneficiary shall provide a statement having regard to Article 5(1) of
Commission Regulation 1407/2013/EU - by way of means with facilities for
determining compliance with the conditions set out therein - concerning the total
amount of de minimis aid it has received during the fiscal year when the aid was
granted and the two previous fiscal years.
Section 35/B1
Subsection (2d) of Section 25/B contains aid provided for in Commission Regulation
(EU) No. 1407/2013 of 18 December 2013 on the application of Articles 107 and 108
of the Treaty on the Functioning of the European Union to de minimis aid.
Annex 1 to Act XCV of 20052
I. Non-homeopathic (allopathic) preparations

I.A All allopathic preparations, except allergens
I.A New marketing authorization
I.A.1.1. National procedure
I.A.1.1.a. Original, or original product line extension
I.A.1.1.b. Generic, or generic product line extension
I.A.1.1.c. Other, or other product line extension
I.A.1.2. Mutual recognition procedure
I.A.1.2.a. Original, or original product line extension
RMS
I.A.1.2.a.1.
CMS
I.A.1.2.a.2.
I.A.1.2.b. Generic, or generic product line extension
RMS
I.A.1.2.b.1.
CMS
I.A.1.2.b.2.

2 Established by Section 47, Annex No. 1 of Act CCXXIV of 2015, effective as of 23 January 2016.
I.A.1.2.c. Other, or other product line extension

I.A.1.2.c.1. RMS
I.A.1.2.c.2. CMS
I.A.2. Modification of
marketing
authorization
I.A.2.1. National
I.A.2.1.a. Type IA-IB
I.A.2.1.b. Type II
I.A.2.2.a. Type IA-IB
RMS
I.A.2.2.a.1.
CMS
I.A.2.2.a.2.
I.A.2.2.b. Type II
RMS
I.A.2.2.b.1.
CMS
I.A.2.2.b.2.
I.A.2.3. Changes not effecting the summary of product characteristics, p
and the package leaflet
[Act XCV of 2005, Subsection (2) of Section 10]
I.A.2.3.a. Submissions lodged under Subsection (4
30/2005 (VIII. 2.) EüM on the Labels and
Products for Human Use
I.A.2.3.b. Other submissions
I.A.2.4. Transfer of marketing authorization (succession)
I.A.2.5. In the Hungarian marketing authorization, addition or removal
already been authorized under the mutual recognition procedure
I.A.2.6. Switching to the global identification system
I.A.2.7. Change in the classification of the product
I.A.3. Renewal of marketing authorization
I.A.3.1. National
I.A.3.1.a. Original
I.A.3.1.b. Generic
I.A.3.1.c. Other
I.A.3.2.a. Original
RMS
I.A.3.2.a.1.
CMS
I.A.3.2.a.2.
I.A.3.2.b. Generic
RMS
I.A.3.2.b.1.
CMS
I.A.3.2.b.2.
I.A.3.2.c. Other
I.A.3.2.c.1. RMS
I.A.3.2.c.2. CMS
I.A.4. Withdrawal of marketing authorization
I.A.5. Annual maintenance of marketing authorization
I.B Allergens
I.B.1. New marketing authorization
I.B.1.1. National
I.B.1.1.a. Starting materials (mono-component)
I.B.1.1.b. Mixed allergens (multi-component)
I.B.1.1.c. Other
I.B.1.2. Mutual recognition procedure
RMS
I.B.1.2.a.1.
CMS
I.B.1.2.a.2.
RMS
I.B.1.2.b.1.
CMS
I.B.1.2.b.2.
I.B.1.2.c. Other
I.B.1.2.c.1. RMS
I.B.1.2.c.2. CMS
I.B.2. Modification of marketing authorization
I.B.2.1. National
I.B.2.1.a. Type IA-IB
Starting materials (mon
I.B.2.1.a.1.
Mixed allergens (multi-c
I.B.2.1.a.2.
Other
I.B.2.1.a.3.
I.B.2.1.b. Type II
Starting materials (mon
I.B.2.1.b.1.
Mixed allergens (multi-c
I.B.2.1.b.2.
Other
I.B.2.1.b.3.
I.B.2.2.a. Type IA-IB
RMS
I.B.2.2.a.1.
Starting ma
I.B.2.2.a.1.1.
Mixed allerg
I.B.2.2.a.1.2.
Other
I.B.2.2.a.1.3.
CMS
I.B.2.2.a.2.
Starting ma
I.B.2.2.a.2.1.
Mixed allerg
I.B.2.2.a.2.2.
Other
I.B.2.2.a.2.3.
I.B.2.2.b. Type II
RMS
I.B.2.2.b.1.
Starting ma
I.B.2.2.b.1.1.
Mixed allerg
I.B.2.2.b.1.2.
Other
I.B.2.2.b.1.3.
CMS
I.B.2.2.b.2.
Starting ma
I.B.2.2.b.2.1.
Mixed allerg
I.B.2.2.b.2.2.
Other
I.B.2.2.b.2.3.
I.B.2.3. Changes not effecting the summary of product characteristics, p
I.B.2.3.a. Submissions lodged under Subsection (4

30/2005 (VIII. 2.) EüM on the Labels and
Products for Human Use
I.B.2.3.b. Other submissions
I.B.2.4. Transfer of marketing authorization (succession)
I.B.2.5. In the Hungarian marketing authorization, addition or removal
I.B.2.6. Switching to the global identification system
I.B.2.7. Change in the classification of the product
I.B.3. Renewal of marketing authorization
I.B.3.1. National
I.B.3.1.c. Other
I.B.3.2.a. RMS
Starting ma
I.B.3.2.a.1.
Mixed allerg
I.B.3.2.a.2.
Other
I.B.3.2.a.3.
I.B.3.2.b. CMS
Starting ma
I.B.3.2.b.1.
Mixed allerg
I.B.3.2.b.2.
Other
I.B.3.2.b.3.
I.B.4. Withdrawal of marketing authorization
I.B.5. Annual maintenance of marketing authorization
I.B.5.1. Starting materials (mono-component)
I.B.5.2. Mixed allergens (multi-component)
I.B.5.3. Other
II. Homeopathic preparations
II.A. New authorizations
II.A.1. Mono-component medicinal product
II.A.1.1. If the active constitue
European Pharmacopoe
national pharmacopoeia
II.A.1.2. If the active constituent
the European Pharmaco
II.A.2. Multi-component medicinal product
II.A.2.1. If the active constituen
of active substances wh
Pharmacopoeia or, fa
pharmacopoeia of one of
II.A.2.2. If the active constitue
active substances whic
II.A.3. Other
II.B. Modification of marketing authorization
II.B.1. Type IA-IB
II.B.1.1. Mono-component medicinal product
II.B.1.1.a. If the active constitue
II.B.1.1.b. If the active constituent
II.B.1.2. Multi-component medicinal product
II.B.1.2.a. If the active constituen

II.B.1.2.b. If the active constitue
II.B.1.3. Other
II.B.2. Type II
II.B.2.1. Mono-component medicinal product
II.B.2.1.a. If the active constitue
II.B.2.1.b. If the active constituent
II.B.2.2. Multi-component medicinal product
II.B.2.2.a. If the active constituen
II.B.2.2.b. If the active constitue
II.B.2.3. Other
II.B.2.3.a. Submissions lodged under Subsection (4
30/2005 (VIII. 2.) EüM
II.B.2.3.b. Other submissions
II.B.3. Changes not effecting the summary of product characteristics, p
II.B.4. Transfer of marketing authorization (succession)
II.B.5. In the Hungarian marketing authorization, addition or removal
II.B.6. Switching to the global identification system
II.B.7. Change in the classification of the product
II.C. Renewal of marketing authorization
II.C.1. Mono-component medicinal product
II.C.1.1. If the active constitue
II.C.1.2. If the active constituent
II.C.2. Multi-component medicinal product
II.C.2.1. If the active constituen
II.C.2.2. If the active constitue
II.C.3. Other
II.D. Annual maintenance of marketing authorization
II.D.1. Mono-component medicinal product
II.D.2. Multi-component medicinal product
II.E. Withdrawal of marketing authorization
III. Other procedures
III.A. New parallel import authorization
III.B. Modification of parallel import authorization
III.B.1. Type IA-IB
III.B.2. Type II
III.C. Renewal of parallel import authorization for five more years
III.D. Maintenance of parallel import authorization
III.E. Extension of the shelf life of a production batch
III.F. Authorization of deviation from the marketing authorization for certain production batches
III.G. Clinical trials on investigational medicinal products, other than the non-commercial trials referred to i
(1) of Section 2 of Decree No. 35/2005 (VIII. 26.) EüM on the Clinical Trial of Investigational Medicinal
on the Implementation of Good Clinical Practice
III.G.1. Authorization
III.G.2. Modification of authorization for clinical trial
III.H. Authorization for the manufacture of medicinal products
III.H.1. On-site inspection (each facility)
III.H.2. New authorization for the manufacture of medicinal products
III.H.3. Modification of authorization for the manufacture of medicinal products
III.I. Authorization for the wholesale distribution of medicinal products
III.I.1. On-site inspection (each facility)
III.I.2 New authorization for the wholesale distribution of medicinal products
III.I.3. Modification of authorization for the wholesale distribution of medicinal
products
III.I.4. Registration of the activities of brokers of medicinal products
III.I.5. Amendment of the registration of the activities of brokers of medicinal products
III.J. Inspection of laboratories involved in safety testing of investigational medicinal products in accordanc
laboratory practice, and issue of the related certificate
III.K. Issue of certificate verifying inspection of the manufacturing and distribution of medicinal products t
marketing in Hungary on a regular basis, and the conformity of such medicinal products, separately for e
III.L.1
III.M. Reclassification as medicinal products
III.N. Authorization for genetic modification operations
III.N.1. Authorization for the genetic modification of natural organisms: separately for each genetic modification
III.N.2. Implementation of facilities engaged in genetic modification operations: separately for each facility
III.N.3. Contained use of genetically modified organisms and products produced therefrom: separately f
operation
III.N.4. Deliberate release into the environment of genetically modified organisms and products produced th
genetic modification operation and for each site of release
III.N.5. Placing on the market of genetically modified organisms and products produced therefrom: separately
operation
III.N.6. Exportation and importation of genetically modified organisms and products produced therefrom: separa
III.N.7. Carriage of genetically modified organisms and products produced therefrom: separately for each applic
III.O. Reclassification of a test site to a first grade clinical pharmacological test site
III.P. Therapeutic substances (preparations) other than pharmaceuticals
III.P.1. Modification of marketing authorization
III.P.2. Renewal of marketing authorization
III.Q. Registration of production, import and distribution of active substances of medicinal products
III.Q.1. Registration of production, import and distribution of active substances of medicinal products, for th
authorization
III.Q.2. Registration of the production of active substances of medicinal products, for those not registered as
July 2013
III.Q.2.1. Basic registration fee and authorization of the principal active substance
III.Q.2.2. Separately for each active substance manufactured and for each location
III.Q.3. Registration of the importation of active substances of medicinal products, for those not registered as
2013
III.Q.3.2. Separately for each active substance imported and for each location
III.Q.4. Registration of distribution of active substances of medicinal products, for those not registered as such d
III.Q.4.2. Separately for each active substance distributed and for each location
III.Q.5 Registration of production, import and distribution of active substances of medicinal products, with new
for each active substance and for each location
III.Q.6. Amendment of the registration of production, import and distribution of active substances of medicinal p
each notification
1 Repealed by Section 32 of Act CLXXII of 2016, effective as of 1 January 2017.

III.R. On-site inspection of production of active substances upon request, for the purpose of verification of GM
each location)
III.S. Issue of official certificate to the customs authority on the authorization for the wholesale distribution
products, or on the authorization of importation of medicinal products for placing on the domestic marke
III.T.1 Authorization of production of ex tempore radiopharmaceutical product, first product (first potency, first
III.U2 Authorization of further production of ex tempore radiopharmaceutical product (separately for each pote
III.V.3 Modification of production authorization of ex tempore radiopharmaceutical product (separately for e
form)
III.W.4 Renewal of production authorization of ex tempore radiopharmaceutical product (separately for each po
III.X.5 Annual maintenance of production authorization of ex tempore radiopharmaceutical product (s
pharmaceutical form)
III.Y.6 Withdrawal of production authorization of ex tempore radiopharmaceutical product (separately for e
form)
Annex 2 to Act XCV of 20057
In accordance with Section 28 of this Act below is the list of the substances which
are classified as dangerous psychotropic substances, treated as narcotic drugs, by
means other than Lists I and II of the Annex to the Convention on Psychotropic
Substances signed in Vienna on 21 February 1971 and promulgated by Law-Decree
No. 25 of 1979, and whose domestic classification differs from the international
classification:
List A):
List of the substances which are treated in Hungary the same as the psychotropic
substances contained in List I of the Annex to the Convention on Psychotropic
No. 25 of 1979, which cannot be used for medical purposes, and can be used solely
for scientific purposes:
A B
Official name (or other name or
abbreviation, or colloquial Chemical name
reference frequently used in other
countries)
1. AL 4-allyl-oxi-3.5-dimethoxy-phenethyl-amine
2. BDB 1-(1,3-benzo-dioxol-5-il)-2-butane-amine
1-(1,3-benzodioxol-5-yl)butan-2-ylazan
3. BZP 1-benzylpiperazine 1-benzyl-1,4-diaza-cyclohexane
N-benzylpiperazine
4. 2C-I 2,5-dimethoxy-4-iodophenethylamine
4-iodo-2,5-dimethoxyphenethylazan
5. 2C-T-2 2,5-dimethoxy-4-ethylthiophenethylamine
4-ethylsulfanyl-2,5-dimethoxy-phenethylazan
6. 2C-T-7 2,5-dimethoxy-4(n)-propyl-thio-phenethyl-amine
2,5-dimethoxy-4-(propylsulfanyl)-phenethylazan
7.8
8. 4-fluoroamphetamine 1-(4-fluorophenyl)propan-2-amine
4-FA, 4-FMP
1 Enacted by Section 22, Annex 1 of Act CLXXXVIII of 2017, effective as of 18 January 2018.
7 Enacted by Section 183, Annex 7 of Act LXVII of 2016, effective as of 17 July 2016.
8 Repealed by Section 20 of Act CLIV of 2020, effective as of 1 January 2021.
9. FLEA N-hydroxy-N-methyl-3,4 ethylene-dioxi-amphetamine or

N-hydroxy-3,4-methylene-dioxi-metamphetamine
N-[1-(1,3-benzodioxol-5-yl)propan-2-yl]-N-methylhydroxylamin
10. JWH-018 naphthalen-1-yl(1-pentyl-1H-indol-3-yl)methanone
11. JWH-081
(4-methoxynaphthalen-1-yl)(1-pentyl-1H-indol-3-yl)methanone
12. JWH-073 (1-butyl-1H-indol-3-yl)(naphthalen-1-yl)methanone
13. JWH-122 (4-methylnaphthalen-1-yl)(1-pentyl-1H-indol-3-yl)methanone
14. JWH-210 (4-ethylnaphthalen-1-yl)(1-pentyl-1H-indol-3-yl)methanone
15. MAL 3,5-dimethoxy-4-methallyl-oxy- phenethyl-amine
3,5-dimethoxy-4-(2-methylallyloxy)-phenethylazan
16. MBDB 2-(methylamino)-1-(3,4-methylene-dioxy-fenil)-butane or
N-methyl-1-(1,3-benzo-dioxol-5-il)-2-butane-amine
[1-(1,3-benzodioxol-5-yl)butan-2-yl](methyl)azan
17. mCPP meta-chlorophenylpiperazine or
(meta-chlorophenylpiperazine) [1-(3-chlorophenyl)piperazine]
17.a 4-MA, 4-methylamphetamine 1-(4-methylphenyl)propan-2-amine
18. 3,4-methylendioxypirovalerone 1-(1,3-benzodioxol-5-yl)-2-(pyrrolidin-1-yl)pentan-1-one

MDPV
19. 4-methylethcathinone 2-(ethylamino)-1-(4-methylphenyl)propan-1-one
4-MEC
20. Mephedrone 1-(4-methylphenyl)-2-methylaminopropan-1-on
21. Methylone 1-(1,3-benzodioxol-5-yl)-2-(methylamino)propan-1-one
22. N-Me-1-PEA 1-(N- methyl-amino)-1-phenyl-ethane or N-methyl-1-
phenethyl-amine
23. 1-PEA 1-amino-1-phenyl-ethane or 1-phenethyl-amine
24. PMMA Paramethoxymethylamphetamine or
N-methyl–1-(4-methoxyphenyl)–2-aminopropane or
p-methoxy-N, α-dimethylphenethylamine
25. TMA-2 2,4,5-trimethoxyamphetamine
(2,4,5-trimethoxyamphetamine) 1-(2,4,5-trimethoxyphenyl)propan-2-ylazan
26. 5-IT 5-(2-aminopropyl)indole
27. 1-naphyrone 1-(naphthalen-1-yl)-2-(pyrrolidin-1-yl)pentan-1-one
28. 2-aminoindane 2,3-dihydro-1H-inden-2-amine
29. 2-DPMP, Desoxypipradrol 2-(diphenylmethyl)piperidine
30. 2-naphyrone 1-(naphthalen-2-yl)-2-(pyrrolidin-1-yl)pentan-1-one
31. 3-MeO-PCE N-ethyl-1-(3-methoxyphenyl)cyclohexanamine
32. 4-MeO-PCP 1-[1-(4-methoxyphenyl)cyclohexyl]piperidine
33. 5-IAI 5-iodo-2,3-dihydro-1H-inden-2-amine
34. 5-MeO-AMT 1-(5-methoxy-1H-indol-3-yl)propan-2-amine
35. α-Pyrrolidinovalerophenone, α-PVP 1-phenyl-2-(1-pyrrolidinyl)-1-pentanone
36. AM-2201
1-[(5-fluoropentyl)-1H-indol-3-yl]-(naphthalen-1-yl)methanone
37. AMT (alpha-methyltryptamine) 1-(1H-indole-3-yl)propan-2-amine
38. Camfetamine N-methyl-3-phenylbicyclo[2.2.1]heptan-2-amine
39. CP 47,497 C8-homologue 2-(3-hydroxycyclohexyl)-5-(2-methylnonan-2-yl)phenol
40. CRA 13 naphthalen-1-yl [4-(pentyloxy)naphthalen-1-yl]methanone
41. D2PM, Diphenylprolinol diphenyl(pyrrolidin-2-yl)methanol
42. DBZP 1,4-dibenzylpiperazine
43. Desoxy-D2PM 2-(diphenylmethyl)pyrrolidine
44. Dimethocaine 3-(diethylamino)-2,2-dimethylpropyl-4-aminobenzoate
45. DMAA 4-methylhexan-2-amine
46. Etaqualone 3-(2-ethylphenyl)-2-methylquinazolin-4(3H)-one
47. Ethylphenidate ethyl phenyl(piperidin-2-yl)acetate
48. GBL, gamma-butyrolactone dihydrofuran-2(3H)-one
49. HU-210
9-(hydroxymethyl)-6,6-dimethyl-3-(2-methyloctan-2-yl)-6a,7,10,10a-
tetrahydrobenzo [c]chromen-1-ol
50. Ibogain
(6R,6aS,7S,9R)-7-ethyl-2-methoxy-6,6a,7,8,9,10,12,13-octahydro-
5H-6,9-methanopyrido[10,20:1,2]azepino [4,5-b]indole
51. MDAI 6,7-dihydro-5H-indeno[5,6-d][1,3]dioxol-6-amine
52. Methoxetamine 2-(ethylamino)-2-(3-methoxyphenyl)cyclohexanone
53. MPA, Methylthienylpropamine N-methyl-1-(thiophen-2-yl)propan-2-amine
54. ODT, O-desmethyltramadol 3-{2-[(dimethylamino)methyl]-1-hydroxycyclohexyl}phenol
55. para-methyl-4-methylaminorex /
4,4’-DMAR 4-methyl-5-(4-methylphenyl)-4,5-dihydro-1,3-oxazol-2-amine,
or
4-methyl-5-(4-methylphenyl)-1,3-oxazolidine-2-imine
tautomers
56. Pentedron, 2-methylamino–1-phenyl–1-pentanone
β-ethyl-methcathinone
57. MBZP 1-benzyl-4-methylpiperazine
58. pFBT, 4-fluorotropacocaine 8-methyl-8-azabicyclo[3.2.1]oct-3-yl 4-fluorobenzoate
59. pFPP 1-(4-fluorophenyl)piperazine
60. Phenazepam
7-bromo-5-(2-chlorophenyl)-1,3-dihydro-2H-1,4-benzodiazepin-2-one
61. Salvinorin A (2S,4aR,6aR,7R,9S,10aS,10bR)-9-(acetyloxy)-2-(3
furanyl)dodecahydro-6a,10b-dimethyl-4,10-dioxo-2H-naphtho[2,1-c]pyran-
acid methyl ester
62. TFMPP 1-[3-(trifluoromethyl)phenyl]piperazine
63. β-Me-PEA 2-phenylpropan-1-amine
64.1
65. Homoamphetamine 3-amino-1-phenyl-butane
66. AH-7921
3,4-dichloro-N-[[1-(dimethylamino)cyclohexyl]methyl]benzamide
67. 25I-NBOMe
4-iodine-2,5-dimethoxy-N-(2-methoxy-benzyl)phenethyl-amine
68. AB-CHMINACA
N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-
3-carboxamide
69.2
70. 5F-AB-PINACA
N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(5-fluoropentyl)-1H-indazole-
3-carboxamide
71. AB-PINACA
N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-
carboxamide
72. α-PVT, alpha-PVT, 2-(pyrrolidin-1-yl)-1-(thiophen-2-yl)pentan-1-one
alpha-pyrrolidinopentiothiophenone
73. MDMB-CHMICA
N-[[1-(cyclohexylmethyl)-1H-indol-3-yl]carbonyl]-3-methyl-valine,
methyl ester
74. MTP, methcathinone thiophen 2-(methylamino)-1-(thiophen-2-yl)propan-1-one
analog
75. N-ethylnorketamine 2-(2-chlorophenyl)-2-(ethylamino)cyclohexanone
76. AM-1248 azepane isomer adamant-1-yl[1-(1-methylazepan-3-yl)-1H-indol-3-yl]
methanone
77.3
78. MT-45 1-cyclohexyl-4-(1,2-diphenylethyl)piperazine
79.4 4-benzylpiperidine 4-(phenylmethyl)piperidine
80.5 3,4-dichloromethyl-phenidate/ methyl-2-(3,4-dichlorophenyl)-2-[piperidin-2-yl]acetate
3,4-CTMP
1 Repealed by Paragraph a) of Section 3 of Act CXII of 2021, effective as of 25 November 2021.

4 Enacted by Section 30, Annex 1 of Act CLXXII of 2016, effective as of 1 January 2017.
81.1 A-836,339 N-[3-(2-methoxyethyl)-4,5-dimethyl-1,3-thiazol-2-ylidene]-

2,2,3,3-tetramethylcyclopropane- carboxamide
82.2 MXP, methoxyphenidine, 1-[1-(2-methoxyphenyl)-2-phenylethyl]piperidine

2-MeO-diphenidine
83.3 3F-phenmetrazine, 2-(3-fluorophenyl)-3-methylmorpholine

meta-fluoro-phenmetrazine,
meta-F-phenmetrazine
84.4 N-(2-methoxyethyl)-N-(1-methyl ethyl)-2-(1-pentyl-1

N-(2-methoxyethyl)-N-(1-methylethyl)-2-(1-pentyl-1H-indol-3-yl)-4-thiazol-methanamine
H-indol-3-yl)-4-thiazol-methanamine
85.5
N,N-diethyl-2-(1-pentyl-1H-indol-3-yl)-4-thiazol-methanamine
N,N-diethyl-2-(1-pentyl-1H-indol-3-yl)-4-thiazol-methanamine
86.6 alpha-PBT; alfa-PBT; a-PBT; 2-(Pyrrolidin-1-yl)-1-(thiophen-2-yl)butan-1-one

α-Pyrrolidinobutiothiophenone
87.7
88.8
89.9 MTTA; MTA; Mephtetramine 2-[(Methylamino)methyl]-3,4-dihydronaphthalen-1 (2H)-one
90. Nitracaine 3-(Diethylamino)-2,2-dimethylpropyl 4-nitrobenzoate

10
91. EG-018 (naphthalen-1-yl) (9-pentyl-9H-carbazol-3-yl)-methanone
11
92.
12
93-95.
13
96. 4F-MDMB-BICA
14 Methyl-2-{[1-(4-fluorobutyl)-1H-indole-3-carbonyl]amino}-3,3-dimethylbut
- and the stereoisomers of the substances contained in the list above, if they exist
due to their chemical structure, and if not subject to specific special provisions;
- the salts of the substances contained in the list above, including the salts of the
above-mentioned stereoisomers, if they exist.
List B):
List of the substances which are treated in Hungary the same as the psychotropic
substances contained in List II of the Annex to the Convention on Psychotropic
No. 25 of 1979, which can be used for medical purposes subject to strict control:
7 Repealed by Paragraph b) of Section 3 of Act CXII of 2021, effective as of 25 November 2021.
8 Repealed by Paragraph b) of Section 3 of Act CXII of 2021, effective as of 25 November 2021.
12 Repealed by Paragraph c) of Section 3 of Act CXII of 2021, effective as of 25 November 2021.
14 Enacted by Section 2, Point 1 of Annex 1 of Act CXII of 2021, effective as of 25 November 2021.
Official name
(or other name or Chemical name
abbreviation, or colloquial
reference frequently used in
other countries)
Buprenorphine
21-cyclopropyl–7-α-[(S)–1-hydroxy–1,2,2-trimethylpropyl]–6,14-endo-ethano–6,7,8,14-
tetrahydrooripavine
Ketamine 2-(2-chlorophenyl)-2-(methylamino)-cyclohexanone
Pentazocine (2R, 6R,

11R)-1,2,3,4,5,6-hexahydro-6,11-dimethyl-3-(3-methyl-2-butenyl)-2,6-methano-3-
benzazocin-8-ol
Poppy straw All parts of cut poppy; however, the seeds harvested and cleaned are
not treated as controlled substances
Tapentadol 3-[(2R,3R)-1-(dimethylamino)-2-methylpentan-3-yl]-phenol
- and the stereoisomers of the substances contained in the list above, if they exist
due to their chemical structure, and if not subject to specific special provisions;
- the salts of the substances contained in the list above, including the salts of the
above-mentioned stereoisomers, if they exist.
TARTALOMJEGYZÉK
Act XCV of 2005 1

on Medicinal Products for Human Use and on the
Amendment of Other Regulations Related to Medicinal
Products 1
Section 1 1
Scope 6
Section 2 6
Clinical Trial 7
Section 3 7
Provisions for the Manufacture of Medicinal Products 8
Section 4 8
Section 4/A 10
Authorization for the Marketing of Medicinal Products 10
Section 5 10
Section 6 12
Provisional and Special Marketing 13
Section 7 13
Obligation to Conduct Post-Authorization Studies 13
Section 7/A 14
Updating the Risk Management System 14
Section 7/B 14
Labelling and Package Leaflet 14
Section 8 14
Section 9 15
Section 10 15
Wholesale Distribution of Medicinal Products 15
Section 11 15
Parallel Import 16
Section 11/A 16
Supply of Medicinal Products 16
Section 12 16
Section 13 17
Section 14 17
Special Provisions Relating to Narcotic Drugs and
Psychotropic Substances, Medicinal Products Classified
as Narcotics or Psychotropic Substances and New
Psychoactive Substances 17
Section 15 17
Section 15/A 20
Section 15/B 20
Section 15/C 20
Section 15/D 21
Sections 15/E-15/F 21
Public Service Obligation Placed on Marketing

Authorization Holders, Authorized wholesale
distributors of medicinal products and Operators of
Pharmacies Relating to the Supply of Medicinal
Products 22
Section 16 22
Section 16/A 25
Supervision and Regulatory Control of Medicinal
Products and the Supply of Medicinal Products 26
Section 17 26
Section 17/A 27
Section 17/B 27
Pharmacovigilance 28
Section 18 28
Section 18/A 30
Section 18/B 31
Section 18/C 31
Section 18/D 31
Section 18/E 32
Section 19 32
Section 20 32
Temporarily Rendering Electronic Information
Inaccessible 34
Section 20/A 34
Liability for Damages in Connection with
Investigational Medicinal Products or the
Administration of Medicinal Products and Liability for
Violations of Rights Relating to Personality 35
Section 21 35
Specific Provisions Relating to Active Substances and
Excipients 36
Section 22 36
Brokering of Medicinal Products 36
Section 23 37
Patients' Rights in Connection with the Use of
Medicinal Products 37
Section 24 37
General Provisions Relating to the Use of Medicinal
Products 37
Section 25 37
Section 25/A 42
Section 25/A 42
Fees Charged for Authorization Procedures Relating to
Medicinal Products 42
Section 25/B 42
Compassionate Use of Medicinal Products, and/or Use
of Medicinal Products Before Placed on the Market 44
Section 25/C 44
Use of Ex Tempore Radiopharmaceutical Products 46

Section 25/D 46
Miscellaneous Provisions 46
Section 26 46
Section 27 48
Section 28 48
Section 29 48
Section 30 48
Section 31 48
Closing Provisions 48
Section 32 48
Section 32/A 52
Section 32/B 52
Section 33 52
Section 34 53
Section 35 54
Section 35/A 54
Section 35/B 55
Annex 1 to Act XCV of 2005 55
Annex 2 to Act XCV of 2005 61

Hungarian Act XCV of 2005

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Hungarian Act XCV of 2005

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Act XCV of 2005 - on Medicinal Products for Human Use and on the Amendment of Netjogtár

Other Regulations Related to Medicinal Products

Act XCV of 2005

on Medicinal Products for Human Use and on the Amendment of

1 Promulgated on 15 July 2005.

10)1 'representative of the marketing authorization holder' shall mean a natural or

1 Amended: by subparagraph a) Section 95 of Act CLXXVI of 2011. In force: as of 1. 01. 2012.

Provisions for the Manufacture of Medicinal Products

(6a)1 If based on the findings of an inspection of any manufacturing site of

1 Established: by Section 15 of Act XL of 2013. In force: as of 29. 04. 2013.

(12) At the request of a manufacturer of medicinal products, the government body

Authorization for the Marketing of Medicinal Products

1 Amended: by subparagraph a) Section 55 of Act CLXXIII of 2010. In force: as of 1. 01. 2011.

(3)1 Upon receipt of a request specified in Paragraph b) of Subsection (2) hereof

Provisional and Special Marketing

Obligation to Conduct Post-Authorization Studies6

Updating the Risk Management System4

Labelling and Package Leaflet

1 Enacted: by Section 84 of Act CLXXVI of 2011. In force: as of 21. 07. 2012.

Wholesale Distribution of Medicinal Products

(1)1 Wholesale distribution of medicinal products shall comprise all activities

Supply of Medicinal Products

Special Provisions Relating to Narcotic Drugs and Psychotropic Substances,

(3)1 The authorization and registration proceedings relating to narcotic drugs,

1 Established by Subsection (1) of Section 14 of Act CLXXXVIII of 2017, effective as of 1 January

(1)6 A specific substance or compound may be classified as new psychoactive

1 Enacted: by Section 77 of Act CLIV of 2009. In force: as of 1. 01. 2010.

(1)1 Within one years of classification of substances as new psychoactive

1 Amended by subparagraph a) Section 65 of Act LXXIX of 2012, subparagraph e) Section 88 of Act

Public Service Obligation Placed on Marketing Authorization Holders,

1 Established by Subsection (1) of Section 56 of Act CCXLIV of 2013, effective as of 24 December

(2c)1 In the event of a shortage or risk of shortage of a medicinal product as

1 Established by Section 53 of Act LXXVII of 2015, effective as of 1 July 2015.

(1) Marketing authorization holders, authorized wholesale distributors of medicinal

Supervision and Regulatory Control of Medicinal Products and the Supply of

(4) In connection with proceedings conducted within the framework of regulatory

1 Amended by Paragraph c) of Section 113 of Act CLXXXVI of 2015.

1 Amended by Paragraph d) of Section 255 of Act L of 2017.

(1) The government body for pharmaceuticals shall operate a pharmacovigilance

1 Amended by Point 7 of Section 109 of Act CI of 2021.

The marketing authorization holder shall operate a pharmacovigilance system for

(1) If the marketing authorization holder intends to make a public announcement

1 Enacted: by Section 88 of Act CLXXVI of 2011. In force: as of 21. 07. 2012.

a)1 the date when proclaimed;

Temporarily Rendering Electronic Information Inaccessible7

1 Amended by Paragraph g) of Section 255 of Act L of 2017.

Liability for Damages in Connection with Investigational Medicinal

1 Established by Section 77 of Act CLXVIII of 2020, effective as of 1 January 2021.

b) for compensatory damages for loss of property under Paragraph a),

Specific Provisions Relating to Active Substances and Excipients1

Brokering of Medicinal Products4

1 Enacted: by Section 84 of Act CCXII of 2012. In force: as of 2. 01. 2013.

Patients' Rights in Connection with the Use of Medicinal Products

General Provisions Relating to the Use of Medicinal Products

1 Established: by Section 85 of Act CCXII of 2012. In force: as of 2. 01. 2013.

(2f)1 Pursuant to Subsection (2e), with the exception of authorization under

1 Enacted by Section 239 of Act XCIX of 2021, effective as of 1 December 2021.

1 Amended by Point 14 of Section 109 of Act CI of 2021.

Fees Charged for Authorization Procedures Relating to Medicinal Products4

(1) Authorization and modification procedures and other proceedings - shown in

1 Enacted by Subsection (2) of Section 44 of Act XXXIV of 2016. Amended by Paragraph e) of

1 Enacted by Section 90 of Act CXI of 2014, effective as of 1 January 2015.

Compassionate Use of Medicinal Products, and/or Use of Medicinal Products

(1)5 Within the framework of a compassionate use program, investigational