MINISTRY OF HEALTH F-01-SRS-PF

NATIONAL DIRECTORATE OF PHARMACY AND DRUGS

DEPARTMENT OF HEALTH REGISTRATION OF MEDICINES AND OTHERS Version 07-30-13
health PRODUCTS FOR HUMAN HEALTH
HEALTH REGISTRATION APPLICATION EVALUATION SECTION
Pharmacy and page 1 of 2
Drugs
Application for Health Registration for a Pharmaceutical Product PLEASE FILL OUT THE FORM ELECTRONICALLY.
DO NOT LEAVE BLANK SPACES.
1. TYPE OF PROCEDURE
— 1.1.1 New active ingredient □ 1.3 Fiscal Stamp
1.1 New Health Registry
1—1 1.1.2 Known active ingredient □

1.2 Renewal of Health Registration □ 1.2.1 Expedited Renewal □

1.2.2 Renewal with changes □ 1.2.3 Renewal with prior control □

1.2.4 Health Registration Number: 1.2.5 Expiration date:

2. PRODUCT DATA
2.1 PRODUCT NAME:

2.2. ACTIVE INGREDIENT (Up to 2 active ingredients):

2.2.1 NAME OF THE ACTIVE INGREDIENT (According to INN) 2.2.2 CONCENTRATION:

2.3 PHARMACEUTICAL FORM: 2.4 ROUTE OF ADMINISTRATION:

2.5 TYPE OF PRODUCT:

□ Medication □ Vaccine □ Phytopharmaceutical
□ Biological □ Blood derivative □ Medical Gas
□ Biotechnological □ Low molecular weight heparin □ Supplement dietary with therapeutic property
□ Radiopharmaceutical—••Radioactive□ Cold Kit □ Narcotic, psychotropic or precursor
□ Official preparation made to great esc □ Negativity to Diethylene Glycol or Ethylene Glycol
□ Homeopathic □ Data Protection
□ Orphan
2.6 CONDITION OF SALE: □ 2.7 ATC CODE:
Medical Prescription □ Without Medical Prescription
2.8 CONTAINER(S):

2.9 PRESENTATION(S):
2.9.1 COMMERCIAL:

2.9.2 MEDICAL SAMPLE:

2.9.3 HOSPITAL:

3. MANUFACTURER AND CONDITIONER INFORMATION

3.1 MANUFACTURER:
3.1.1 NAME: 3.1.2 COUNTRY:

3.1.3 ADDRESS: 3.1.4 EMAIL:

3.2 CONDITIONER: □ Primary □ Primary and Secondary

3.2.1 NAME: 3.2.2 COUNTRY:

3.2.3 ADDRESS: 3.2.4 EMAIL:

3.3 CONDITIONER: □ Secondary

3.3.1 NAME: 3.3.2 COUNTRY:

3.3.3 ADDRESS: 3.3.4 EMAIL:

4. DATA OF THE OWNER

4.1 OWNER:
4.1.1 NAME: 4.1.2 COUNTRY:

4.1.3 ADDRESS: 4.1.4 EMAIL:

 F-01-SRS-PF
MINISTRY OF HEALTH
NATIONAL DIRECTORATE OF PHARMACY AND DRUGS
$ Version 07-30-13
health DEPARTMENT OF HEALTH REGISTRATION OF MEDICINES AND OTHER PRODUCTS
FOR HUMAN HEALTH
Page 2 of 2
Pharmacy and Drugs HEALTH REGISTRATION APPLICATION EVALUATION SECTION
Application for Health Registration for a Pharmaceutical Product
PLEASE FILL OUT THE FORM ELECTRONICALLY. DO NOT LEAVE BLANK SPACES.
5. DISTRIBUTOR(S) INFORMATION
5.1 DISTRIBUTOR:
5.1.1 NAME: 5.1.2 PHONE: 5.1.3 FAX: 5.1.4 EMAIL:

5.1.5 LICENSE NUMBER:

6. THOSE RESPONSIBLE FOR THE PROCESS
6.1 REGISTRATION APPLICANT COMPANY:
6.1.1 NAME: 6.1.2 PHONE: 6.1.3 FAX: 6.1.4 EMAIL:

6.1.5 RUC NUMBER:

6.1.6 ADDRESS:
6.2 LEGAL REPRESENTATIVE OF THE COMPANY APPLYING FOR REGISTRATION:
6.2.1 NAME: 6.2.2 PHONE: 6.2.3 FAX: 6.2.4 EMAIL:

6.2.5 ID NUMBER:
6.2.6 ADDRESS:
6.3 LAWYER:
6.3.1 NAME: 6.3.2 PHONE: 6.3.3 FAX: 6.3.4 EMAIL:

6.3.5 ADDRESS:
6.3.6 ID NUMBER: 6.3.7 APPROPRIATION NUMBER:
6.3.8 SIGNATURE:

6.4 PHARMACEUTICAL:
6.4.1 NAME: 6.4.2 PHONE: 6.4.3 FAX: 6.4.4 EMAIL:

6.4.5 ADDRESS:
6.4.6 ID NUMBER: 6.4.7 APPROPRIATION NUMBER:
6.4.8 SIGNATURE:

7. OBSERVATIONS

8. ENDORSEMENT OF THE NATIONAL COLLEGE OF
PHARMACISTS
9. LEGAL BASIS
□ Law 1 of January 10, 2001
□ Decree 178 of July 12, 2001
□ Decree 105 of April 15, 2003
□ Decree 197 of April 14, 2009 (Does not apply to Huérfano and Gases Medici
□ Decree 340 of August 27, 2007 (Only for biological and biotechnological
□ Decree 321 of June 17, 2009 (Only for radiopharmaceuticals
□ Decree 303 of December 11, 2003 (Only for Orphans
□ Decree 290 of August 12, 2004 (Only for Homeopathic
□ Decree 1389 of September 4, 2012 (Clinical Studies and Protection of

10. DOCUMENTS ATTACHED TO THE APPLICATION (SEE CHECK LIST IN ANNEX 1)

ANY ADULTERATION OR FORGERY IN THE STATEMENTS OR INFORMATION PRESENTED ON THIS FORM AND
ATTACHED DOCUMENTS IS CAUSE FOR CANCELLATION OF THE HEALTH REGISTRATION AS ESTABLISHED BY ARTICLE 43 OF THE LAW
1 OF JANUARY 10, 2001.
FOR USE OF THE NATIONAL DIRECTORATE OF PHARMACY AND DRUGS

DATE OF APPLICATION NUMBER: SIGNATURE OF OFFICIAL:

ADMISSION:
*END OF FORM*
 F-01-SRS-PF/Annex 1
MINISTRY OF HEALTH
NATIONAL DIRECTORATE OF PHARMACY AND DRUGS Version 07-30-13
DEPARTMENT OF HEALTH REGISTRATION OF MEDICINES AND OTHER PRODUCTS
$ health FOR HUMAN HEALTH
page 1 of 2
Pharmacy and Drugs HEALTH REGISTRATION APPLICATION EVALUATION SECTION
Check list
PLEASE FILL OUT THE FORM ELECTRONICALLY.
DOCUMENTS SUBMITTED FOR THE HEALTH REGISTRATION
General requirements
For Pharmacy
Pharmaceutical products and Drug use Invoice

1 Application form signed by the lawyer and responsible pharmacist, with the endorsement seal of the National
College of Pharmacists □
2 Receipt of Service Fee
3 IEA payment receipt, with External Analysis and Quote Request Form * □
4 Original power of attorney or copy of your registration note □
5
Certificate of Free Sale or Pharmaceutical Product (WHO Type) in original for foreign products or copy of the
Current Operation License issued by the National Directorate of Pharmacy and Drugs for national products
•
6 Certificate of Good Manufacturing Practices in original or copy of your registration note
□
7
8
Original qualitative-quantitative formula signed by the person in charge of the laboratory or owner of the product
Analysis method □
9 Analysis certificate *
10 Finished Product Specifications * □
11
12
Lot Key
Labels (primary and secondary) □
13 Monograph * □
14 Stability Studies *(a) □
15
16
Information on waste disposal *
Other explanatory documents □
Annexes (to be submitted separately from general and specific requirements) □
17 Clinical Studies(b) *
□
18 Sample(c)
□
19 Analytical standards, when required
Biological and Biotechnological (additional specific requirements) □
20
21
The specifications of the sources and the techniques or procedures used to obtain the active ingredient *
Manufacturing process of the finished product * □
22 Controls in process, including the procedures used to ensure as much as possible the absence of potentially
pathogenic agents or immunological reactions *
23 Non-Clinical Studies *
24 Risk management program and pharmacovigilance plan for biotechnology companies * □
25 Storage, distribution and transportation conditions *
Homeopathic (additional specific requirements) □
26
27
Descriptive report on obtaining and controlling the homeopathic strain *
Justification of its homeopathic nature * □
28 Description of the Control and Manufacturing Process * □
□
29 Dilution and dynamization methods *
□
30
31
Quality Certificate for Raw Materials for new product *
Quality Certificate for Excipient * □
□
32
Bibliographic reference and description of the analysis of phytosanitary residues for raw material with known
active ingredient * □
33 Homeopathic Strain Analysis Method *
□
34
35
Homeopathic Strain Analysis Certificate *
Homeopathic Strain Specifications * □
36 Bibliographic reference of the known homeopathic strain * □
37 Quality Certificate of the new homeopathic strain * □
38 Toxicological, Clinical and Tolerance Tests for homeopathic medicines with approved indication with new
homeopathic strains. * □
Orphans (additional specific requirements)

39
Notarial declaration referring to the countries in which the product is registered and the year in which it was
registered, or, failing that, Certification from the Health Authority of the country of origin or manufacturing where
this information is recorded.
•
40 Points 3, 8, 9, 10, 18 and 19 do not apply to the health registry.
□
 F-01-SRS-PF/Annex 1
MINISTRY OF HEALTH
NATIONAL DIRECTORATE OF PHARMACY AND DRUGS
Version 07-30-13
DEPARTMENT OF HEALTH REGISTRATION OF MEDICINES AND OTHER PRODUCTS
§ health FOR HUMAN HEALTH
Pharmacy and Drugs HEALTH REGISTRATION APPLICATION EVALUATION SECTION
Check list
PLEASE FILL OUT THE FORM ELECTRONICALLY.
DOCUMENTS SUBMITTED FOR THE HEALTH REGISTRATION
Radiopharmaceuticals (additional specific requirements) Invoice
41 Complete detailed explanation of internal radiation dosimetry *
□
In the case of radionuclide generators, a general description of the system must also be included, along with a
detailed description of its components that may affect the composition or quality of the daughter radionuclide, as
□
42 well as the qualitative and quantitative characteristics of the eluate or of the sublimated *

In the case of radiopharmaceuticals requiring extemporaneous preparation, additional detailed instructions for
extemporaneous preparation and quality control of this preparation and, where applicable, maximum storage
time during which any intermediate preparation, such as an eluate, or the radiopharmaceutical ready for use
□
43 meet the intended specifications *
44 Specifications and description of the type and shape of the container-closure system. *
45
46
Specifications that include all analytical controls and acceptance limits according to the type of product. *
Specifications related to manufacturing and preparation procedures of products. * □
47 Current Public Health operating license issued by the National Directorate of Pharmacy and Drugs. □
48
Import, transport and handling license for radioactive products issued by the General Directorate of Health
(Forms PR-100 and PR-200) □
49 Points 3, 8 and 19 do not apply to the health registry.
Renewal of Homeopathic and Orphans (additional specific requirements)
Sworn declaration from the legal representative of the laboratory that there are no changes in the technical
50 documentation and that the product continues to comply with the approved requirements in the case of
renewals.
□
Documents for the Analysis Laboratory: (does not apply to Orphans or Radiopharmaceuticals)
51 Photocopy of the Quantitative Formula
□
52
53
Photocopy of the Method of Analysis or Reference to a Pharmacopoeia
Photocopy of the Certificate of Analysis of the product ** □
54 Photocopy of the Pattern Analysis Certificate (when pattern is required) ** □
□
55 Photocopy of label art (primary and secondary) in cases where the name of the product in the sample differs from
the name that will be used for marketing in Panama. ** □
Explanatory notes:

(to) It does not apply to radiopharmaceuticals and medicinal gases such as oxygen and nitrogen. Nor to dietary supplements with therapeutic
properties, for which information must be presented regarding the conservation and biological stability of the product, which must be
accompanied by an explanation of the method used to determine it. If dietary supplements with therapeutic properties and
radiopharmaceuticals request a shelf life greater than 24 months stored at 30 ° C, they must present complete stability studies.

For the registration of innovative medicines, new indications not included in the accepted references and new associations of active
(b) ingredients, new pharmaceutical forms and new routes of administration, which merit it. Likewise, in the case of biological and
biotechnological medicines.

(c) It does not apply to radiopharmaceuticals, cytotoxics or other products whose handling is considered dangerous. In these cases, attach a
photo of the product showing the primary and secondary packaging.
*Not required in Renewal. However, they will be requested except for points 10, 13, 15, 17, 20 to 38 and 41 to 46 in case of significant changes
in the formula.

**Not required in Renewal.

Please present all stationery in a folder with a clip. To do this, place the last page of the file as page number 1 and continue with the numbering
of each page consecutively until you reach the first page of the file, which would be the application form. In such a way that additional
documents that have to be incorporated into the file can be attached to it and pages easily, without having to remove the sheets from the
hook. (Clinical Studies and photocopies of documents, organize them in separate folders.) In the folio column, place the corresponding number
for each attached document.

The documentation must be presented in Spanish. In the case of documents written in a language other than Spanish, a translation into Spanish
by a public interpreter authorized in Panama must be attached. In the case of clinical studies, they will be accepted in English accompanied by a
summary of the research phases in Spanish.
In the points where it is indicated that the original must be presented, a photocopy authenticated by a notary in the original will be accepted,
except for the Certificate of Free Sale or Pharmaceutical Product (OMS type).

Official Documents such as Certificate of Free Sale or Pharmaceutical Product (WHO Type) and Certificate of Good Manufacturing Practices, as
well as certifications or clarifications complementary to them, and Legal Documents such as Power of Attorney, that are issued abroad, They
must comply with legal requirements. (Consularized or Apostille)
FOR USE OF THE NATIONAL DIRECTORATE OF PHARMACY AND DRUGS
APPLICATION ENTRY: DATE OF ADMISSION: APPLICATION NUMBER: SIGNATURE OF OFFICIAL:

□ Approved

□ Rejected
 F-01-SRS-PF/Instructions
MINISTRY OF HEALTH
NATIONAL DIRECTORATE OF PHARMACY AND DRUGS
Version 07-30-13
DEPARTMENT OF HEALTH REGISTRATION OF MEDICINES AND OTHER PRODUCTS
$ health FOR HUMAN HEALTH
Page 1 of 5
Pharmacy and Drugs HEALTH REGISTRATION APPLICATION EVALUATION SECTION
Instructions for filling out the health registration application form for pharmaceutical products
PLEASE FILL OUT THE FORM ELECTRONICALLY. DO NOT LEAVE BLANK SPACES.
1. TYPE OF PROCEDURE

Check the box that corresponds to the process of the product, whether it is new health registration (new active ingredient or known active
ingredient) or renewal of health registration (expedited, with changes or with prior control).
1.1 New Health Registry Check this box if the product does not have a health registration.
1.1.1 New active ingredient Check this box if the active ingredient is the first time it is registered in Panama.
1.1.2 Known active ingredient Check this box if the active ingredient is already registered in Panama.
1.2 Renewal of Health Registration Check this box if the product already has health registration .
1.2.1 Expedited Renewal Note: For the process to be expeditious, the file must also meet the established requirements.

Note: For the process to be expeditious, the file must also meet the established requirements.

1.2.2 Renewal with changes Check this box if changes are presented with the renewal request that have not been notified and approved
by this Directorate.
1.2.3 Renewal with prior control

Check this box if there is a significant change in the qualitative formula of the product that has not been
notified and approved by the Management or if the renewal request has been entered after the expiration
date of the health registration. A significant change is understood to be when the formula is quantitatively
modified in quantities that exceed 10% of excipients with respect to its total weight. In the case of liquids,
this modification can be with respect to the weight or the total volume of the formula. Likewise, qualitative
changes in the formula (adding, eliminating or replacing an excipient) are considered significant changes,
unless it is a coloring, flavoring or an ingredient used in printing ink in solid pharmaceutical forms for oral
administration. (Tablets, capsules)

Prior control means that for the issuance of the health registration certificate or renewal of the health
registration, the analysis of the product with satisfactory results is required by the Analysis Laboratory.
Enter the health registration number assigned to the product. If it is a new record, enter N/A (Not
1.2.4 Health Registration Number applicable).

1.2.5 Expiration date Enter the expiration date of the health record. Use day/month/year format. If it is a new record, enter N/A
(Not applicable).

1.3 Fiscal Stamp

This space is to place proof of payment of the tax stamp, either with the postage stamp or by entering the
number of the tax stamp payment receipt. This data can be entered by hand.

2. PRODUCT DATA
2.1 PRODUCT NAME
Enter the commercial name of the product (or generic name) according to the packaging and attached
documents, including in the description the concentration (up to two active ingredients) and the
pharmaceutical form. Ex. Ibuprofen 400mg Tablets/Melonox 75-150mg Capsules/Clotrimazole 1% Cream.

2.2. ACTIVE INGREDIENT (Up to 2 Raw material, substance or mixture of substances with an expected pharmacological effect.
active ingredients)
2.2.1 NAME OF THE ACTIVE Place the name of the active ingredient according to the international nonproprietary name (INN). Up to 2
INGREDIENT (According to INN) active ingredients. If you only have one active ingredient, place a line in the other available field. If you have
more than 2 active ingredients, place a line in both blank fields.

2.2.2 CONCENTRATION Enter the amount of active ingredient per dosage unit. (Ex. 10 mg/tablet, 5mg/ml, 2mg/g (in semi-solid
pharmaceutical forms it can be indicated as a percentage, such as 5%, etc.) Up to 2 active ingredients. If you
only have one active ingredient, place a line in the other available field. If you have more than 2 active
ingredients, place a line in both blank fields.

2.3 PHARMACEUTICAL FORM
2.4 ROUTE OF ADMINISTRATION
2.5 TYPE OF PRODUCT
Place the pharmaceutical form of the product (Ex. Tablets, capsules, syrup, solution, cream, etc.)
Place the route of administration of the product (Ex. oral, topical, rectal, ophthalmic, vaginal, intravenous,
intramuscular, subcutaneous, etc.)
Check the box that corresponds to the product to be registered: medicine, biological, biotechnological,
radiopharmaceutical (radioactive or cold kit), official preparation produced on a large scale, homeopathic,
orphan, phytopharmaceutical, medicinal gas or dietary supplement with therapeutic properties. In turn, for
medications, check the corresponding box if it is a vaccine, blood product, low molecular weight heparin,
narcotic, psychotropic or precursor, as well as if you are requesting Data Protection. Also, check the
corresponding box in case of pharmaceutical products that require negativity testing for diethylene glycol or
ethylene glycol.

Medication : pharmaceutical product used for the prevention, diagnosis or treatment of a disease or
pathological state, or to modify physiological systems for the benefit of the person to whom it was
administered.
 Biological : medicine whose active ingredient is obtained from living organisms or their tissues.

F-01-SRS-PF/Instructions
MINISTRY OF HEALTH
NATIONAL DIRECTORATE OF PHARMACY AND DRUGS
$ DEPARTMENT OF HEALTH REGISTRATION OF MEDICINES AND OTHER PRODUCTS
Version 07-30-13

health FOR HUMAN HEALTH

Page 2 of 5
Pharmacy and Drugs HEALTH REGISTRATION APPLICATION EVALUATION SECTION

Instructions for filling out the health registration application form for pharmaceutical products
PLEASE FILL OUT THE FORM ELECTRONICALLY. DO NOT LEAVE BLANK SPACES.

Biotechnological : medicine whose active ingredient is a protein type developed by genetic engineering,
obtained through techniques of combining recombinant nucleic acids (DNA and RNA), monoclonal
antibodies and others.

Radiopharmaceutical : medicine prepared for therapeutic or diagnostic purposes, containing one or more
radioactive isotopes. Included are the Cold Kits, a set of Reagents or ligands, which are any industrial
preparation that must be combined with the radionuclide to obtain the final radiopharmaceutical.

Official preparation manufactured on a large scale : these are pharmaceutical preparations or medications
whose formulation appears in a pharmacopoeia accepted by the Health Authority or National Formulary or
Remington Pharmaceutical Science, manufactured by a manufacturer or national drugstore, intended to
supply directly to pharmacies or other establishments. authorized by the Health Authority.

Homeopathic : medicine that uses microdoses of plant, mineral, animal extracts or a mixture of these.
Orphan : drug used to treat rare diseases or conditions that affect a small population. It refers to potential
active ingredients, in which there is no interest on the part of the producing laboratories for their
commercial development as medicine, since it does not represent an economic incentive, even though they
may satisfy health needs.

Phytopharmaceutical : Product obtained from plants and their mixtures, prepared in the form of an extract,
lyophilized, distilled, tincture, decoction or any other preparation with a defined pharmaceutical form, which
is presented with therapeutic, diagnostic or preventive utility.

Medical Gas : gas for medical use such as Oxygen, Air, among others.
Dietary supplement with therapeutic properties : dietary supplement or its synonymous terms, such as
food supplement, nutritional supplement is the product that contains a substance or mixture of substances
intended to complement the nutrients normally present in foods, and to which some therapeutic property is
attributed. . These may be vitamins, minerals, amino acids, herbs or other substances of natural origin even
when their nutritional value has not been proven.

Vaccine : medicine prepared from dead or weakened viruses or bacteria, or parts of them, that are
introduced into the body so that it recognizes it and develops antibodies. With a vaccine, the immune
system acquires a "cellular memory" that allows it to respond quickly to an infection that has not been
suffered before naturally, avoiding the disease.

Blood derivative : medicine obtained by industrial procedures in authorized centers, whose raw material is
human blood or plasma; Such medicines include in particular albumin, coagulation factors and
immunoglobulins of human origin.

Low molecular weight heparin : medicine used for its anticoagulant properties obtained from
unfractionated heparin through various chemical or enzymatic depolymerization procedures.

Narcotic : name used to refer to substances with high potential for dependence and abuse. The term
narcotic can be applied to substances that belong to different pharmacological categories (narcotic
analgesics, central nervous system stimulants, hallucinogens, etc.).

Psychotropic : medication that has an effect on mental functions and has the potential to cause addiction.
Includes central nervous system stimulants (amphetamines), sedative-hypnotics (barbiturates) and
hallucinogens (LSD, mescaline).

Precursor : substance for medicinal use frequently used in the illicit manufacture of narcotic drugs and
psychotropic substances. It applies to pharmaceutical products that have so-called precursors in their
composition, such as Pseudoephedrine, Ergotamine and Ephedrine.

Negativity to Diethylene Glycol or Ethylene Glycol : Check this box for liquid pharmaceutical products for
oral administration that contain the excipients glycerin, sorbitol or propylene glycol in their composition.

Data Protection : Check this box if the drug has a new chemical entity for which you want protection of test
data and other undisclosed data.

2.6 CONDITION OF SALE Check the corresponding box, according to the sales condition requested for the product: sale with a medical
prescription or sale without a medical prescription.
 F-01-SRS-PF/Instructions
MINISTRY OF HEALTH
NATIONAL DIRECTORATE OF PHARMACY AND DRUGS Version 07-30-13
DEPARTMENT OF HEALTH REGISTRATION OF MEDICINES AND OTHER PRODUCTS
$ health FOR HUMAN HEALTH
Page 3 of 5
Pharmacy and Drugs
HEALTH REGISTRATION APPLICATION EVALUATION SECTION

Instructions for filling out the health registration application form for pharmaceutical products
PLEASE FILL OUT THE FORM ELECTRONICALLY. DO NOT LEAVE BLANK SPACES.
2.7 ATC CODE Enter the ATC code. This is the anatomical-therapeutic-chemical classification code assigned by the
Collaborating Center for Drug Statistics Methodology of the World Health Organization (WHO). In this
system, medications are classified in a 5-level structure. The first level corresponds to the anatomical group
and is identified with a letter. In this first level there are 14 groups in total. The second level corresponds to
the therapeutic group and is identified with a two-digit number. The third level corresponds to the
therapeutic/pharmacological subgroup and is identified with a letter. The fourth level corresponds to the
therapeutic/pharmacological/chemical subgroup and is identified with a letter. The fifth level corresponds to
the name of the active ingredient or association of active ingredients and is identified with a two-digit
number. For large-scale official preparations, phytopharmaceuticals, homeopathic medicines and dietary
supplements with therapeutic properties, enter N/A (Not applicable). If there is no code for the specific
product up to the fifth level, enter the code that best defines it up to the highest possible level. To enter this
information you can consult the ATC index at the address http://www.whocc.no/atc_ddd_index/ and the L-
SRS-01-ATC guide.

2.8 CONTAINER(S) Provide a description of the primary packaging that indicates the type and material of the packaging, as well
as its appearance, and a description of the secondary packaging (if applicable). Ex. Colorless, transparent
aluminum/pvc blister in cardboard box. Amber bottle with metal lid in a cardboard box.

Primary container : that which contains a pharmaceutical product and is in direct contact with it. (Ex. Blister,
bottle, vial, ampoule, sachet, etc.)
Secondary packaging : material within which the primary packaging is placed, used for the distribution and
marketing of the product. Usually a cardboard box.
Note : It is important that you place all the containers of the product that you plan to put on the market,
both for commercial presentation, medical sample and for hospital presentation, both for the process of
new health registration and for renewal of health registration. Likewise, labels for all containers must be
submitted for evaluation. The information provided at this point will appear on the Health Registration
Certificate.

2.9 PRESENTATION(S) Description that indicates the volume, weight or number of units of the pharmaceutical product contained in
the container. Ex. Box with 30 tablets. Box with 10 ampoules of 2ml each. Bottle with 60ml. Box with a 30g
tube.

Note: It is important that you place all the presentations of the product that you plan to put on the market,
both for commercial presentation, medical sample and hospital presentation, both for the process of new
health registration and for renewal of health registration.
Likewise, the labels of all these presentations must be presented for evaluation. The information provided at
this point will appear on the Health Registration Certificate.

2.9.1 COMMERCIAL
2.9.2 MEDICAL SAMPLE
2.9.3 HOSPITAL
Place the description that corresponds to the commercial presentation.
Enter the description that corresponds to the medical sample presentation. If you do not have this type of
presentation, enter N/A (not applicable).
Enter the description that corresponds to the hospital presentation. If you do not have this type of
presentation, enter N/A (Not applicable).

3. MANUFACTURER AND CONDITIONER INFORMATION

3.1 MANUFACTURER
3.1.1 NAME Enter the name or company name of the product manufacturer.
3.1.2 COUNTRY Enter the country where the product is manufactured.
3.1.3 DIRECTION Enter the full address of the place where the product is manufactured.
3.1.4 EMAIL Enter the manufacturer's email address. If you do not have an email address, enter N/A (Not applicable).

3.2 CONDITIONER Fill out this point if a laboratory other than the one declared as the manufacturer of the product is involved
in the packaging or packaging of the product. In this case, check the box that identifies the type of packaging
or packaging carried out, whether primary or primary and secondary. If this is not the case, enter N/A (Not
applicable) in the fields for name, country, address and email.
3.2.1 NAME Enter the name or company name of the product conditioner.
3.2.2 COUNTRY Enter the country where the conditioner and product are located.
3.2.3 DIRECTION Enter the complete address of the place where the product is packaged.
3.2.4 EMAIL Enter the email address of the conditioner. If you do not have an email address, enter N/A (Not applicable).

MINISTRY OF HEALTH F-01-SRS-PF/Instructions

NATIONAL DIRECTORATE OF PHARMACY AND DRUGS
DEPARTMENT OF HEALTH REGISTRATION OF MEDICINES AND OTHER PRODUCTS
Version 07-30-13
FOR HUMAN HEALTH
$ health HEALTH REGISTRATION APPLICATION EVALUATION SECTION
Pharmacy and Drugs

Instructions for filling out the health registration application form for pharmaceutical products
PLEASE FILL OUT THE FORM ELECTRONICALLY. DO NOT LEAVE BLANK SPACES.
3.3 CONDITIONER Fill out this point in the event that a laboratory other than the one declared as the manufacturer of the
product and as the primary conditioner of the product participates in the packaging or packaging of the
product. In this case, check the box that identifies the type of packaging or packaging performed, such as
secondary packaging or packaging. If this is not the case, enter N/A (Not applicable) in the fields for name,
country, address and email.

3.3.1 NAME Enter the name or company name of the product conditioner.
3.3.2 COUNTRY Enter the country where the conditioner and product are located.
3.3.3 DIRECTION Enter the complete address of the place where the product is packaged.
3.3.4 EMAIL Enter the email address of the conditioner. If you do not have an email address, enter N/A (Not applicable).

4. DATA OF THE OWNER

4.1 OWNER It refers to the owner or owner of the product, and therefore, of the health record.
4.1.1 NAME Enter the name or company name of the owner of the product.
4.1.2 COUNTRY Enter the country of the product owner.
4.1.3 DIRECTION Enter the full address of the owner of the product.
4.1.4 EMAIL Enter the email address of the product owner. If you do not have an email address, enter N/A (Not applicable).

5. DISTRIBUTOR(S) INFORMATION
5.1 DISTRIBUTOR
Marketing company residing in Panama. If there is more than one distributor, present on an attached sheet
the information requested in this section for each of the additional distributors.
5.1.1 NAME Enter the name or company name of the distributor.
5.1.2 PHONE Enter the distributor's telephone number.
5.1.3 FAX Enter the distributor's fax number. If you do not have a fax, enter N/A (Not applicable).
5.1.4 EMAIL Enter the distributor's email address.
5.1.5 LICENSE NUMBER Enter the health license number issued at this Address.
6. THOSE RESPONSIBLE FOR THE PROCESS
6.1 REGISTRATION APPLICANT Company that requests health registration in Panama and represents the owner of the product.
COMPANY

6.1.1 NAME Enter the name or company name of the company requesting registration.
6.1.2 PHONE Enter the telephone number of the legal representative.
6.1.3 FAX Enter the fax number of the company requesting registration. If you do not have a fax, enter N/A (Not
6.1.4 EMAIL applicable).
Enter the email address of the company requesting the health registration.
6.1.5 RUC NUMBER Enter the identification number or unique taxpayer registration number (RUC).
6.1.6 ADDRESS Enter the exact address of the company requesting the health registration.
6.2 LEGAL REPRESENTATIVE OF THE Natural person who represents the company requesting health registration in Panama.
COMPANY APPLYING FOR
REGISTRATION
6.2.1 NAME Enter the full name (first and last names) of the legal representative.
6.2.2 PHONE Enter the telephone number of the legal representative.
6.2.3 FAX Enter the fax number of the legal representative. If you do not have a fax, enter N/A (Not applicable).
6.2.4 EMAIL Enter the email address of the legal representative.
6.2.5 ID NUMBER Enter the personal identity card number of the legal representative.
6.2.6 ADDRESS Enter the exact address of the legal representative of the company requesting the health registration.
6.3 LAWYER Legal representative who makes the request on behalf of the company requesting the health registration.
6.3.1 NAME Enter the full name (first and last names) of the lawyer. If you act as part of a firm
6.3.2 PHONE Enter the telephone number of the lawyer or law firm.
6.3.3 FAX Enter the fax number of the lawyer or law firm. If you do not have a fax, enter N/A (Not applicable).
6.3.4 EMAIL Enter the email address of the lawyer or law firm.
6.3.5 ADDRESS Enter the exact address of the lawyer or law firm.
6.3.6 ID NUMBER Enter the lawyer's personal identity card number.
6.3.7 SUITABILITY NUMBER Enter the lawyer's professional qualification number.
6.3.8 SIGNATURE Place the signature of the requesting attorney.
6.4 PHARMACEUTICAL Pharmacist responsible for endorsing the application.
6.4.1 NAME Enter the full name (first and last names) of the pharmacist.
6.4.2 PHONE Enter the phone number of the pharmacist.
6.4.3 FAX Enter the pharmacist's fax number. If you do not have a fax, enter N/A (Not applicable).
6.4.4 EMAIL Enter the pharmacist's email address.
6.4.5 ADDRESS Enter the exact address of the pharmacist.
6.4.6 ID NUMBER: Enter the pharmacist's personal identity card number.
6.4.7 APPROPRIATION NUMBER: Enter the pharmacist's professional qualification number.
6.4.8 SIGNATURE Place the signature of the responsible pharmacist.

F-01-SRS-PF/Instructions
MINISTRY OF HEALTH
NATIONAL DIRECTORATE OF PHARMACY AND DRUGS Version 07-30-13
DEPARTMENT OF HEALTH REGISTRATION OF MEDICINES AND OTHER PRODUCTS
$ health
Pharmacy and Drugs
FOR HUMAN HEALTH
HEALTH REGISTRATION APPLICATION EVALUATION SECTION Page 5 of 5

Instructions for filling out the health registration application form for pharmaceutical products
PLEASE FILL OUT THE FORM ELECTRONICALLY. DO NOT LEAVE BLANK SPACES.
7. OBSERVATIONS
In this section you must enter any additional comments regarding the product you wish to register. If there are no observations, enter N/A (Not
applicable).
8. ENDORSEMENT OF THE NATIONAL COLLEGE OF PHARMACISTS
In this section the seal corresponding to the Endorsement of the National College of Pharmacists must be placed.
of April 15, 2003. Check the box corresponding to 9 e . n F te U a N l D d A e M cr E et N o T 1 O 9 L 7 E d G e A 1 L April 4, 2009 for all cases, except for
orphans and medicinal gases, for which it does not apply. Only applies to dietary supplements with therapeutic properties and
radiopharmaceuticals, which sol 1 ic 0 it . e D n O u C n U a M vi E d N a T ú O ti S lm AD ay J o U r N a TO 24 S m A e L s A e S s. O L L u I e C g IT o U , D ma (V rq E u R
e L l I a ST c A a D si O lla D q E ue CH c E o Q rr U es E p O on D d E a L a A l N fu E n