Issues associated with the state registration of pharmaceutical substances are regulated by the Ministry of Health Protection of the Republic of Belarus. In accordance with the law of the Republic of Belarus "On medicinal products" active pharmaceutical substances (APIs) are allowed for manufacturing medicinal products in Belarus only after state registration.
Procedure of the state registration includes the following steps:
- primary examination of registration documents;
- GMP inspection of all manufacturing sites involved in manufacturing process (if necessary);
- approbation of quality control methods as well as the analysis of the quality of API;
- specialized examination of registration documents.
What is required for registration
In order to register a foreign pharmaceutical substance, it is necessary to provide the following to the Center for Examination and Tests in Health Service of the Ministry of Health of the Republic of Belarus (Center):
1) Application form with the attached documents:
- legalized Power of Attorney from the applicant to the representative;
- legalized copies of GMP Certificates for all manufacturing sites involved in manufacturing process issued by the competent authorities of countries-manufacturers (with expiration of validity not less than in 6 months);
- legalized copies of the Manufacturer's Authorizations for all manufacturing sites involved in manufacturing process issued by the competent authorities of countries-manufacturers (with expiration of validity not less than in 6 months);
- legalized copy of Registration Certificate issued by the competent authority of country of manufacturer (with expiration of validity not less than in 6 months) or justification of its absence;
- manufacturing process (manufacturing schedules, manufacturing scheme);
- specifications, methods of control of final product and if necessary its validation;
- certificate of analysis for 1 production batch from API manufacturer;
- stability data not less than on 2 batches.
2) Samples of pharmaceutical substance of 1 batch, packaging thereof, standard samples, if necessary.
Possible GMP inspection
After submission of the registration dossier and its preliminary expertise, the Center may request to conduct GMP inspection of all manufacturing sites involved in manufacturing process in case they were not inspected by the Center not earlier than 3 years before submitting the Application.
In case of inspection, the manufacturer will be required to provide the following documents:
- Application form;
- Dossier of the manufacturing site (Site Master File).
Duration of registration process
According to the Belarusian legislation the procedure of state registration of pharmaceutical substance should be conducted within 180 workdays without considering the time for preparation of responses to the remarks. However, in accordance with the usual practice depending upon the completion of the provided materials and scope of documentation, number of requests of the competent authority and other factors the procedure of state registration of pharmaceutical substance in Belarus may constitute about 6-8 months without considering the time for preparation of responses to the remarks.
Validity term and renewal
The Certificate about the state registration of pharmaceutical substance in Belarus is valid on the permanent basis.
In order we could provide you with the information on costs associated with the registration of pharmaceutical substances in Belarus together with the detailed information and list of documents required from your side, as well as a sample of the Power of Attorney for execution, etc. please contact our specialists.