DOCUMENTS REQUIRED FOR REGISTRATION OF MEDICINES

(Structure of registration)

I. General documentation

A. Administrative information.

1     Name of the medicine, dosage form and dosage.

2     Quantitative and qualitative composition of active and ancillary.

3     Pharmacotherapeutic group (ATC code)

4     Sales category (receipt, non-receipt).

5     Amount of the pieces in the pack.

6     Packing, cap.

7     Storage conditions.

8     Storage terms (if needed – storage terms of the medicine after the 1^st opening of the pack or after the dissolution).

9     Information about the Applicant Party (manufacturer):

      9.1. Name and address.

      9.2. Name of the official representative (our company).

10   Information about manufacturer (manufacturers) of the medicine.

      10.1. Name and address including place of manufacturing.

11   Information about manufacturer (manufacturers) of the active ingredient.

      11.1. Name and address.

12   List of countries where this medicine was:

      12.1. registered (including date of registration).

      12.2. dismissed in registration, called off from the market by competent authority or by Applicant Party, operation of registration certificate is discontinued or put on hold by competent authority (with the reason stated).

13   License for trade, authenticated by competent authority. Copy of the license for manufacturing for all places of manufacturing, including copies of GMP certificates, authenticated by competent authority of the host country of the manufacturer.

14   Generalized data of medicine’s characteristics affirmed in other countries.

15   Inventory of the documents of registration materials with the pages indicated (in a case if some parts of the documentation are not included in materials of the dossier it is necessary to note a reason under the proper heading and in the proper place).

      15.1. Samples of dosage forms (exact amount of samples will be provided while registration) in original packing (internal) and secondary package (external).

      15.2. If absent – a sample of the final (internal) package without final marking. Sample in the final (internal) and secondary (external) package is to be provided additionally as soon as it is available. Later for approbation of medicine quality analysis methods it is possible to be requested additional samples, reference substances with certificates for a batch including production date, storage terms and conditions.

      15.3. Quality certificate for three production series of medicine or one certificate for one production series accompanied by liability to provide certificates for another two parties as soon as they are available (all certificates are to be forwarded to every of  declared production places).

B. Brief Characteristics of the medicine’ properties.
    Offers concerning packing, label, instruction for medical use and/or insert sheet.

C. Expert’s inference concerning chemical, pharmacological, toxicological and clinical data
    (resume of the main medicine’s properties).

II. Chemical, pharmaceutical and biological documentation.

Content

1     Composition

      1.1. Composition of the medicine.

      1.2. Packing (brief description).

      1.3. Pharmaceutical formulation

2     Technological process scheme or the project of technological rules of procedure.

3     Control methods of the output materials.

       3.1. Active substance.

 3.1.1. Specifications and standard methodic.

 3.1.2. Scientific data.

 3.1.3. Nomenclature.

 3.1.4. Description.

 3.1.5. Manufacturing.

 3.1.6. Quality control while manufacturing.

      3.2. Packing material (internal/external packing).

      3.3. Analysis methods of intermediate products.

      3.4. Analysis methods of the ready medicine.

      3.5. Stability data.

      3.6. Bioavailability/ equivalence data.

      3.7. Data about possible environmental thread of medicines which consist  genetically modified microorganisms.

      3.8. Other information.

III. Pharmacological and toxicological documentation.

Content

1. Toxicology after single intaking and intaking of the repeated dosages.

2. Influencing on reproductive function.

3. Embryotoxity and teratogenecity data.

4. Mutagenicity data.

5. Carcinogenicity data.

6. Pharmacodynamics:

      6.1. data about specific pharmacological action.

      6.2. general pharmacology data.

      6.3. data of correlation with other medicines.

7. Pharmacokinetics.

8. Data of local stimulating (irritating) action.

9. Other information (alergenicity data and so on).

IV. Clinical documentation.

Content

1. Clinical pharmacology data (pharmacodynamics, pharmacokinetics).

2. Clinical test results, scientific publications.

3. Other information.