Dossier for BAS registration

dok-bad The list of required documents for registration of special food supplements (dietary supplements, BAS) in Ukraine

I. Administration data:

1. Power of Attorney on company “Patern Ltd.”. Depending on the country of origin the PoA has to be legalized in prescribed manner of the country (notarized, with apostil or legalized in the Consulate).

2. Application letter in Word format.

 II. Official documents of the applicant – company (the owner of registration):

3. Document on state registration of an Applicant (certificate on state registration, extract from Chamber and Industry Commerce, etc.).

4. The confirmation document of relationship between manufacturing company and company – applicant (for example – Power of Attorney, letter or part of an agreement).

5. Free form letter the company – applicant takes responsibility on quality and safety of product to be registered in Ukraine.

 Note: if the owner of registration certificate is manufacturing company, then the document from II section will be not needed.

III. Official documents of the manufacturing company:

1. Document on state registration of the manufacturer (certificate on state registration, extract from Chamber and Industry Commerce, etc.).

2. Manufacturing License on BAS production, medicines or analogue document.

3. Certificates, confirming the implementation of system / quality management standards in the production such as GMP, ISO, technical specifications (TS), GOST.

 IV. Administration data on product:

4. Registration certificate on the product in the country of origin, Free Sale certificate and export permission.

5. The list of countries, where the product is registered as BAS. If possible – the copies of registration certificates.

6. Sample of labeling (primary and secondary package), electronic layout.

7. The short characteristic of the product: recommendation for usage, dosage, side effects, precautions, contraindications, condition and terms of storage.

 V. Quality, safety and efficiency of finished product:

8. The composition of finished product. The full indication of composition on the unit of product is obligatory – tablet, capsule, including all excipients and additives. If the product has international index (Е123) – it has to be indicated.

9. Specification of finished product: physic-chemical and biological requirements for the product (description, average weight, microbiological purity, etc.). The specification should contain the references to normative documents on quality control (Pharmacopeia, etc.) or on the internal methods of the company.

10.Quality control methods of finished product according to the Specification: pharmaceutical articles or internal methods of the company.

11. Certificate of analysis (quality) on 2 series of finished product according to the Specification.

12. Data on radiological control and data on pesticide content (for products of plant origin), and / or guarantee letter of radiological and toxicological control.

13. Data on the production process: short characteristics on the production process, description of the technological process, the technical conditions.

14. Scientific information on the safety and efficacy of the product: Expert reports on safety and efficacy, the results of preclinical and clinical trials, literature articles and links. If the product is recommended for children and pregnant women – the protocols of related researches are required protocols related research.

15. Guarantee letter that the product does not contain ingredients of medicines and components of genetically modified raw materials.

16. Samples of the finished product: at least 300 g and at least 2 packages.

Materials after the examination will not be returned.