PER

Pharmaceutical Regulatory
Affairs in Peru
Luis Miguel Meléndez

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Content
• Country Characteristics Authority and Legal framework
• Regulatory process(es): iMAA (3 categories), Renewals,
Variations.
• Country dossier considerations
• Generics
• Biologics – Biotechnological products / Biosimilars
• Post market vigilance (PVG)
• Pricing & Reimbursement

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COUNTRY CHARACTERISTICS
AUTHORITY &LEGAL FRAME
WORK
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• Population: 32.97
• Market Size (USD): 1,920 – 2,400 M
(2020).
• Imported products tend to be the
majority: 65% - 55%
• Pharmacies/Drugstores represent 62%
of the sale channels (with majority
control by one company), public
institutions 28% and private clinics and
similar 10%.

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Competent Authority
Responsible of establish the national health policy and the competent
authorities to regulate and surveillance the pharmaceutical products,
medical devices, sanitary products and others.

• DIGEMID: acronyms for Dirección General de Medicamentos, Insumos

y Drogas (General Directorate of Medicines, Supplies and Drugs).
Webpage: http://www.digemid.minsa.gob.pe/

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“Electronic” submissions
are done on a different
system: VUCE
(“Ventanilla Unica de
Comercio Exterior”)

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DIGEMID Virtual Window Web Application

• Virtual reception of files within the framework of COVID-19
The DIGEMID of the Ministry of Health, makes available to
Pharmaceutical Establishments and the general public the platform
"Web Application of the Virtual Window of DIGEMID - V1", so that they
can submit their procedures virtually from 8:00 am to 4:30 pm, with
the exception of those that are processed through the VUCE.
• Temporarily, the procedures corresponding to the Controlled Products
will continue to be submitted through the institution's front desk, with
the exception of administrative procedures 256 and 257, which will
continue to be submitted through the VUCE.

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MINISTRY OF HEALTH

GENERAL SECRETARIAT

DEPUTY MINISTERIAL OFFICE OF

HEALTH SERVICES AND HEALTH DEPUTY MINISTERIAL
PROTECTION OFFICE OF PUBLIC HEALTH

GENERAL DIRECTORATE OF MEDICINES,

SUPPLIES AND DRUGS (DIGEMID)

DIRECTORATE OF DIRECTORATE OF DIRECTORATE OF DIRECTORATE OF

MEDICAL DEVICES INSPECTIONS AND PHARMACOVIGILANCE,
PHARMACEUTICAL AND SANITARY CERTIFICATION ACCESS AND USE
PRODUCTS (DPF) PRODUCTS (DDMP) (DICER) (DFAU)

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Legal Framework
• Decree No. 023-2005-SA Health Ministry Structure and responsibilities
(Dec2005).
• Decree 006-2007-SA – Guidelines for Clinical Trials (Jun 2007) replaced
by decree 021-2017 – Approve Regulation of clinical trials. (June 2017)
• Law 29459 for Pharmaceuticals, Medical Devices and Health products.
• Decree 001-2009 – Changes to Law 26842 regarding Sanitary
Registration.
• Law 29316 (Jan2009) – Modifies several laws to implement a trade
agreement with USA.
• Decree 002-2009 – Changes to Decree 1072 regarding Data Protection
for Pharmaceutical Products.
• Resolution 092-2009/DIGEMID – Guideline for prescribing information
(May2009).
• Resolution 805-2009/MINSA – Stability Studies (Nov2009).

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• Resolution 737-2010/MINSA - GMP Certification National/Foreign

Facilities (Sep 2010).
• Decree 014-2011 – technical conditions for pharmaceutical labs
dedicated to manufacture, import, export, storage, commercialization of
pharmaceutical products, medical devices and sanitary products.
• Decree 016-2011/SA: “Regulations for the registration, control and
sanitary surveillance of pharmaceutical products, medical devices
and sanitary products” (Effective since Jan 23/2012) and subsequent
modifications.
• Resolution 102-2017: Approve “The List of Documents Considered
Equivalent to the Certificate of Good Manufacturing Practices. (August
2017)
• Resolution 833-2015 -Approved the Technical Document: Manual of
Good Practices for Distribution and Transportation of Pharmaceutical
Products, Medical Devices and Health Products (effective since 2015)
and modified by resolution 1000-2016(December 2016).
• Ministerial Resolution N° 1361-2018/MINSA – National List of essential
medicines

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• Resolution 798-2016 -Modify the Administrative Directive No. 165-

Minsa/Digemid V.01 "Administrative Directive for the Certification of
Good Manufacturing Practices in National and Foreign Laboratories.
(October 2016).
• Resolution 259-2016 - Approve Technical Document: Policy Guidelines
for Access to Biotechnological Products. (April 2016)
• Decree 011-2016 -Supreme Decree that modifies Article 103 of the
Regulation for the Registration, Control and Sanitary Vigilance of
Pharmaceutical Products, Medical Devices and Sanitary Products and
approves the Regulation that regulates the Presentation and Content of
the Documents required in the Registration and Re-registration of
Biological Products: Products Biotechnology. (February 2016).
• Decree 013-2016 - Approve Regulation that regulates the Presentation
and Content of the Documents required in the Registration and Re-
registration of Biological Products that opt for the Way of Similarity.
(March 2016)
• Ministerial Resolution No. 111-2022/MINSA –Resolution approves NTS
No. 182-MINSA/DIGEMID-2022, Technical Health Standard that
regulates stability studies of pharmaceutical specialties. (February 2022).

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Legal Considerations for the Marketing

Application Holder
Regulations do not allow foreign companies/entities to be the
marketing application holder nor the applicant in Peru.

A global company would need to set up its own

offices/subsidiary in the country, which should obtain required
operating licenses (as drug wholesaler “Drogueria”), have a
wharehouse, meet quality systems requirements (GSP, GDP,
GPVP) and have a responsable pharmacist (“Director
Tecnico”).

Alternatively a global company could have a local comercial

act as the MAH of the producto or identify other parties that
could act as such on their name.
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Legal Framework - Type of

Products/Licenses
A. Pharmaceutical products
Medicines
•pharmaceutical specialties (Drug Products)
•diagnostic agents
•radiopharmaceuticals
•medicinal gases
Biologics products
Galenic products
Herbal products
Dietetic/sweeteners products.

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REGULATORY PROCESS

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Regulatory Process
Three (3) sub-types of “pharmaceutical Specialties” with slightly different set
of requirements and statutory review timelines but the same overall regulatory
process.
• Category 1: Active ingredients listed in Peru as essential medicines
(“Petitorio Nacional”)
Review timelines  Statutory = 44 wd/ Experience: 12 mo
• Category 2: Active ingredients registered in a reference country(*)
Review timelines  Statutory = 66 wd / Experience: > 12 - 36 mo (Some
experience 6-10 mo on 2017)
• Category 3: None of the above
Review timelines  Statutory ≤ 264 wd Experience = None.

Reference Countries(*): Reference countries: France, Holland, UK, USA, Canada,

Japan, Switzerland, Germany, Spain, Italy, Belgium, Sweden, Norway, Australia,
Denmark, Republic of Korea, Portugal, Ireland, Hungary and Austria.

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• Only one cycle of questions.

Due to this there tends to be
often “informal”
communications.
• There are two (2) level of
“appeals” (“recurso de
reconsideración” and
“recurso de apelación”

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Marketing Approval Requirements

1. Application form with sworn declaration.
2. Specifications and analytical test methods for active, excipients
and finished product. According to RA guidelines.
3. Specifications of packaging material.
4. Validation of analytical testing (if not compendial).
5. Stability studies.
6. Bioequivalence studies as applicable. As of date of this
presentation only required for predefined set of DS/Products
(Decree 024-2018-SA and RM Nr 404-2021/MINSA)
7. Prescribing information for physician and patient insert.
8. Primary and secondary packaging material text.

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Marketing Approval Requirements

10. CPP from manufacturing or packaging site for imported
products. (Not for “manufactura por encargo”). No older
than 2 years; commercialization and also GMP statement.
Different tradename can be explained.
11. GMP from manufacturing site (reference country or issued by
DIGEMID).
12. Risk management plan, if the pharmaceutical specialty
contains an ingredient API that has not been registered
previously in the country.
13. Supporting data for safety and efficacy (Not for category 1).

Reference Countries: France, Netherlands, United Kingdom, USA, Canada,

Japan, Switzerland, Germany, Spain, Australia, Denmark, Italy, Norway,
Belgium, Sweden, Republic of Korea, Protugal, Ireland, Hungary and Austria.

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Renewals
Sanitary registry is valid for 5 years. The process is called “Reinscription” (Re-
approval).

Requirements:
1. Specific application form (SUCE-VUCE)
2. Affidavit stating that the stability studies have not undergone any
variation and, if they have undergone changes, these are authorized.
3. Technical Data Sheet Project (Proyecto de Ficha Técnica)
4. Certificate of Pharmaceutical Product or Certificate of Free
Commercialization for imported products (CPP or CLV)
5. Certificate of Good Manufacturing Practices (GMP)

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Modifications / Variations
Classified in two groups based on the impact in the quality, safety or efficacy of
the product:

• Minor changes – Notification and 6 months to implement them after they have
been informed. Example (not comprehensive list):
• Administrative changes for legal entity name or address (lic.owner,
importer), RUC, pharmacist responsible.
• Updates to the specifications of API/excipients referred in
Pharmacopoeias.
• Packaging material without affecting stability; change in packaging site
(presenting only cGMP if change doesn’t impact product quality).

• Major changes – Approval needed (44 wd [statutory] approval time). Example

(not comprehensive list):.
• New indication or changes in the one already approved.
• Manufacturing process of API or finished product for biologics.
• Change in shelf life

** Transitions of changes in packaging label and leaflet in the country one can
request inventory depletion of the product without the change for up to one (1)
year.
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Review Fees (USD)

Type of Procedure (*) RA Fees (USD)
Cat.1: 800 – 915
Cat. 2: 800 – 915
New Marketing Application Cat. 3: 915

Biologics: 940 - 950

Variations All: 95-170
Cat.1-3: 740
Renewals
Biologics: 940 - 950

(*) Table provides estimation in US dollars considering the exchange rate as of APR-2022.
Actual values are in the national currencly, Peruvian “Nuevos Soles”.

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COUNTRY DOSSIER
CONSIDERATIONS

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Dossier: Stability
• Climatic zone IVa.
• Stability studies are needed with 3 lots.
• Products in Category 1 or 2, may use 2 lots if the API is
considered stable.
• It is possible to file just long-term stability in case API is not
temperature sensitive. Expiry period will be equal to the time
presented in the study.
T (ºC) % HR
Type Months Testing Frequency
+ 2ºC + 5%
0, 3, 6 or 0, 2, 4, 6
Stable API: 0, 6, 12, annual (based on
40 75 Accelerated 6 experience – not on regulation).
Unstable API: 0, 3, 6, 9, 12, 18, 24, annual
0, 3, 6 or 0, 2, 4, 6
30 65 Long Term ≥6 Stable API: 0, 6, 12, annual.
Unstable API: 0, 3, 6, 9, 12, 18, 24,annual.

6a + 6LT = 24 mo
6a + 12LT = 24 mo ©
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Dossier: Stability
Manufacturer Letterhead
Start and completion Dates
STABILITY REPORT
Product name in Peru:
Dosage form:
API name/Strength:
Product lot number: There is an “Stability Directive”: Ministerial
API lot number:
Resolution N° 111-2022/MINSA: Norma
Product batch size:
Manufacturing date: Técnica de Salud (NTS) N° 182-
Type and number of batches: MINSA/DIGEMID-2022
Closure system description:
Study type (Long term/Accelerated):
Legal entity responsible for the study:
Recommended expiry period:
Recommeded storage conditions: (Can be address with the conclusion)

TEST REFERENCE SPECIFICATION TIME (Months)

0 6 12 24
[Stability guidelines list specific [Recognized Numeric values
testing based on dosage form] Pharmacopoeia/Own
Method]

[SIGNATURE OF QO RESPONSIBLE]
[NAME]/[DATE]
[POSITION]

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Dossier: Stability

• Specific tests required based on dosage form of the

product to be registered. (Minimal test to be performed)
Directiva Sanitaria Nr. 031-MINSA/DIGEMID, N° 182-MINSA/DIGEMID-2022

• If an analytical test listed in the Peruvian stability guideline

will not be excluded, a rationale needs to be submitted in
the initial filing. Micro testing required minimum at start
and end. (Please note: it can be a hard sell)
• Bracketing and Matrixing studies are allowed.
• Commitments are not acceptable.

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Dossier: Specifications and Test Methods

(Recommendations for DS/API, Excipients, DP and (Only Specs) for Packaging)
• Needs to be issued (example: in letterhead) and signed by a representative of
the manufacturing site of a recognized quality laboratory. (Site w/GMPc or GLPc)
• Specifications and analytical testing with their reference in a recognized
Pharmacopoeia; version test must be referenced. (*)
(copies of the
• Test methods should be provided, including compendial methods. Pharmacopoea)
• If analytical testing is not included in the Pharmacopoeia, validation, testing
methods and justification of specifications needs to be submitted.
• Differences in releasing and shelf life specifications needs to be indicated and
supported.
(recommendation: only include release specs and stability specs are inferred from stab.
study)

• For stability: Micro testing is required at least at beginning / ending in

accelerated and Long term.
• Stability required on reconstituted products and diluents are required for IV
products
(*) If there is a product compendial monograph at least specs (tests and acceptance
criteria) should be the same as the pharmacopeia or stricter. ©
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Dossier: Declaration of Specifications

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Dossier: Prescribing information for physician and

patient (patient package leaflet).
• “SmPC” for physician is known as “Ficha Técnica”
• Patient insert is mandatory for medicines under prescription.
• Information of the patient insert is based on the PI for physicians (SmPC)
but using a language that patient can understand. (Art 48, D 016/2011).
• For products classified as Category 1 or Category 2, DIGEMID will accept
the patient insert and “ficha tecnica” approved by the FDA, EMEA or other
reference countries.
• Local label must be consistent with than reference labeling document
(SmPC or USPI or reference country).

Reference Countries: France, Netherlands, United Kingdom, USA, Canada,

Japan, Switzerland, Germany, Spain, Australia, Denmark, Italy, Norway, Belgium,
Sweden, Republic of Korea, Protugal, Ireland, Hungary and Austria.

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Dossier: Prescribing information for physician and

patient (patient package leaflet).
(PIL) Information to be included:
• Product Name, API (INN reference), dosage form
• Composition per dosage unit (name/quantity of API; name of excipients)
• Therapeutic indication, dosage and route of administration
• Contraindication
• Precautions
• Interactions with other medicines or food
• Adverse reactions
• Warnings (including use of specific excipients)
• Treatment in case of overdose
• Storage conditions
• Name and address of mfg site or importer
• Special precautions for the disposal of unused drug or materials that have been in
contact with it
+ Exclusive sections of PI (SmPC) for physicians: Pharmacokinetic,
pharmacodynamics, preclinical data (if applicable) and review date of information.
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Dossier: Packaging Label Requirements

• Primary and secondary packaging label text.

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Dossier: Packaging Label Requirements

PRIMARY (small)
PRIMARY &
REQUIREMENTS SECONDARY Foil Bottles
only if
Storage conditions Yes No special
Lot number / expiration date Yes Yes
Registration number (RS) Yes Yes
RUC Yes No

Name, country of mfg / pckg / importer Yes One logo

Sales condition Yes No

Warning legends (OTC, psychotropics) Yes No

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Dossier: Safety & Efficacy

Category 1 - Not required

Category 2 Verbatim: “[…] Safety and Efficacy Information”

Summary of safety and efficacy. Experience shows: Publications in
recognized journals, expert reports and “reference country
monograph” (SmPC) are accepted

Category 3 Verbatim: “[…] Clinical Trias […]”

Information supporting safety and efficacy (“full”): Preclinical,
Clinical Phase I, II, and III.

• Pharmacovigilance requirements for NCE / Biological products: RMP

(Risk management plan).

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Generics
• Same process and requirements as standard
products (Usually category 1).

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BIOLOGICS –
BIOTECHNOLOGICAL
PRODUCTS
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Biologics / Biosimilars
High activity on 2016:

• DS No 011-2016: Modify Art 103 of DS No 016-2011 (definition of biologics) and

issues issues specific regulations for Biological Biotechnological products. Issued 27-
FEB-2016; Effective 25-AGO-2016.
• DS No 013-2016: Rules for presentation and documents content for licenses
applications for biologics/biotechs trough similarity pathway. Issued 01-MAR-2017 –
Effective 28-AUG-2016
• DS No 020-2021: Regulations for the presentation and content of the documents
required for the registration and registration and re-registration of biological products
biological products: vaccines. Issued 31-JUL-2021 – Effective 26-JAN-2022.

Regulatory Definition of Biotech: Products obtained by means of

“biotechnological processes“: Recombinand DNA technologies,
Monoclonal Antibodies, use of hybridoma techniques and other
[biotechnological] methods as defined by the RA upon

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Dossier and Format:

• ICH CTD structure/standard(s)**; and the following:
• Stability zone IV
• CPP or Free Sale Certificate.
• GMP certificate.
• Proposed product monograph, packaging label texts.
• Risk Management Plan.
• Quality (CMC) summary with focus on “critical” factors and how
this relate to the overall quality and changes through development
(on how this could impact pre-clinical and clinical data validity).

** Quality data has to be signed by “manufacturer” representative but a letter

covering all sections is accepted.

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Requirements (Biotechnological Products)

Applicant should notify what development international/recognized
guidelines (Regulatory frameword) the product followed:
• WHO guidelines/recomendations
• Pan-American Regulatory Harmonization Group (Red PARF)
• International Conference of Harmonization - ICH
• European Medicines Agency – EMA
• Health Canadá
• US – FDA

Review Timelines (statutory):

• Products approved by a reference country: 120 wd
• Others: Up to 12 months

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BIOSIMILARS
Overall the requirements are the same as for a standard
biotechnological product but:

1. Should do an appropriate comparability exercise  dossier

should include characterization of the biosimilar and the
reference biologic product (RBP) as basis for comparability.
2. Pre-Clinical and clinical trial requirements are reduced upon
results of comparability.

Should abide to any of the global regulatory frameworks set for

biotechs/biosimilars with some specifics:
• Immunogenicity always in humans.
• Extrapolation of indications is allowed (apparently no need to
justify).

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POST MARKET VIGILANCE

(PVG)

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Pharmacovigilance
• PSURs are required for products that should submit RMP
(NCE).

Notification of Individual Case Safety Reports (Country):

 SAEs (initial) < 24 h (basic)
 SAE (full report) < 10 days
 All others < 20 days

• There is a requirement to appoint a PVG responsible (similar

to QPPVG).

• Good PVG practices according to Ministerial Resolution No.

1053-2020/MINSA
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PRICING AND
REIMBURSEMENT

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Pricing & Reimbursement

• There is no price control regulation in Peru.
• There is a system of “Price Surveillance” at the point of
sell (just informative).

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Thank you!
Luis Melendez
Sr Mrg. RAFINT
Luis.Melendez@rafint.com
(www.rafint.com)
Not just regulatory services: You get regulatory solutions