Structure of the Registration Dossier and application Form

Complete registration dossier consists comprises four units:

PART I

GENERAL DOCUMENTATION

1 A. Administrative data:
• Name of the medicinal product, pharmaceutical form and dosage;
• Quantitative and qualitative composition of the active substances and excipients;
• Pharmaco-theurapeutic group (ATC classification or proposals for it);
• Proposals on dispensing (on prescription, without prescription);
• Number of units in the package;
• Container, closure;
• Storage conditions;
• Shelf life (in the case of necessity – shelf life after first opening of the container or after reconstitution);
• Information about the applicant:
- Name and address;
- Name of the authorized representative;
• Information about the manufacturer (-s) of the finished medicinal product:
- Name and address including the location of the facility;
• Information about manufacturer (-s) of the active substance (-s):
- Name and address;
• List of the countries in which the medicinal product:
- Has been registered (including the date of registration);
- Has been rejected of registration, withdrawn from the market by the competent authority or by the applicant, registration certificate is revoked or suspended by the competent authority (including specification of the reason);
- Application for the marketing authorization is pending by the competent authority;
• Copy of the manufacturing license for all site of facilities including copies of the GMP certificates legalized by the competent authorities of the host countries of the manufacturer;
• Summary information on the characteristics of the medicinal product (patient information leaflet) adopted in other countries;
• List of the documents containing registration materials with the indication of the pages (if some units of documentation was not included in the materials, it is necessary to give the reason in the appropriate place under the appropriate heading);
• Samples of the medicinal product:
- Sample in the final immediate (inside) and outer (secondary) packaging;
- Certification of quality for three production batches of the medicinal product or one certificate for one produced batch following by the commitment to present certificates for other two parties as soon as they are available (all the certificates are to be submitted for each declared manufacturing site).
- If not available, a sample in the final (inside) package without final labeling should be submitted. In this case a sample in the final (inside) and secondary (outer) packages are to be submitted as soon as it is available. Further on, for final approval of the quality tests of the medicinal product additional samples, reference samples with batch certificates including the date of manufacturing, shelf life and storage conditions could be requested.

1 B. Summary information of the medicinal product’s characteristics; proposals for packaging, labeling, instructions for medical use and/or package insert.

1 C. Expert reports on chemical, pharmaceutical, pharmacological, toxicological and clinical data (final summary of the main product’s characteristics).
 

PART II

CHEMICAL, PHARMACEUTICAL AND BIOLOGICAL DOCUMENTATION

II. Table of contents.
II A. Composition of the medicinal product.
II B. Flow-chart of the manufacturing process or draft of the technological requirements.
II C. Control of the starting materials.
II D. Control tests of the intermediate product.
II E. Control tests of the finished medicinal product.
II F. Data about stability.
II G. Bioavailability / bioequivalence.
II H. Data related to the environmental risk assessment for the products containing genetically modified organisms.
II Q. Other information.


PART III

PHARMOCOLOGICAL AND TOXICOLOGICAL DOCUMENTATION

III. Table of contents.
III A. Toxicity after a single dose and after repeated administration.
III B. Effect on the reproductive function.
III C. Embryo-fetal and perinatal toxicity.
III D. Mutagenic potential data.
III. E. Carcinogenicity data.
III F. Pharmacodynamics:
- Specific pharmacological effect data;
- General pharmacological data.
III G. Pharmacokinetics.
III.H Local tolerance data.
III Q. Other information (alergenicity data etc.).


PART IV

CLINICAL DOCUMENTATION

IV. Table of contents.
IV A. Clinical pharmacology (pharmacodynamics and pharmacokinetics).
IV B. Results of the clinical trials, scientific publications).
VI Q. Other information.

Application Form

APPLICATION

For conducting expert evaluation of the materials pertinent to the medicinal product submitted for state registration (re-registration)

Application received on “___” _________200 ¹ _______________

1. Name of the medicinal product (in Ukrainian and English):

2. International non-proprietary name or common name (in English):

3. Pharmaceutical form (in Ukrainian and English):

4. Packaging:
- outer:
- immediate:

5. Information about applicant (for domestic manufacturers – in Ukrainian, for foreign ones – in English):
- Name of the company (firm):
- Legal address:
- Location address:
- Phone:
- Fax:
- Director’s name:
- Authorized representative of the applicant in Ukraine (in Ukrainian):
- Last name, name, family name:
- Legal address:
- Location address:
- Phone:
- Fax:

6. Manufacturer (-s) of the medicinal product (for domestic manufacturers – in Ukrainian, for foreign ones – in Ukrainian and English):

6.1. - Name of the company (firm):
- Legal address:
- Phone:
- Fax:
- Director’s name:
- Manufacturing of the medicinal product takes place (tick off the necessary item):
a. Fully at the above-mentioned company (firm);
b. Partially at the above-mentioned company (firm);
c. Fully at the other company (firm).

6.2. - Name of the company (firm):
- Legal address:
- Phone:
- Fax:
- Director’s name:
- Manufacturing of the medicinal product takes place (tick off the necessary item):
a. Fully at the above-mentioned company (firm);
b. Partially at the above-mentioned company (firm);
c. Fully at the other company (firm).

7. Quantitative and qualitative composition of the medicinal product including excipients, manufacturers of the active substances and excipients
- Expressed by weight or biological units of pharmaceutical form: dragees, tablets, suppositories, ampoules, vials, as percentage or mg/ml, mg/g: ointments, creams, solutions, powders for reconstitution, collections
Substance
Quantity per unit of the pharmaceutical form
Manufacturer

8. Pharmaceutical effect:

9. ATC classification or proposal for it:

10. Sphere of use (indicate diseases, at which the medicinal product is recommended as preventive or curative remedy):

11. Recommended doses:
single: average maximum
daily: average maximum
course: average maximum

12. Registration in other countries (list of the countries)

13. Patent protection in Ukraine (cross out the necessary item) yes no

13.1. If “yes”, provide the following information:
Patent number:
Date of issue:
Term of validity:
Patent holder:

14. Protection of the trade mark in Ukraine (cross out the necessary item): yes no

14.1. If “yes”, provide the following information:
Document number:
Date of issue:
Term of validity:
Document holder:

15. Shelf life of the medicinal product:

16. Storage conditions (tick off the necessary item):
Temperature:
a. -18°C
b. (-1-2 °C) - (-8°C)
c. 4-8°C - 15°C
d. Room temperature
Special conditions:
a. Toxic
b. Under control of the International Drug Control Committee
c. Drastic
d. Other

17. Dispensing category in the applicant’s country (fill in letter index of the corresponding dispensing category
A – Strictly on doctor’s prescription (without renewal);
Á - In pharmacies on prescription
B – In pharmacies and branch pharmacies
à – In non-pharmacy outlets.

18. Is advertising and promotion activity foreseen (cross out the necessary item) yes no
The applicant assumes responsibility for efficacy, safety and quality of the medicinal product as well as assures reliability of the information contained in the registration materials.

Date of filling in
“___” ________200

Signature of the company’s director or authorized representative

Seal