In accordance with the Decision of the Council of the Eurasian Economic Commission of November 03, 2016, No. 78, the state registration of medicinal product produced outside of Belarus is able only with conducting GMP conformity assessment for all manufacturing sites involved in manufacturing process conducted by one of the member state of the Eurasian Economic Union (Russia, Belarus, Kazakhstan, Kyrgyzstan and Armenia).
In order to conduct GMP conformity assessment according to the demands of the Eurasian Economic Union it is necessary to provide Application for issuance of the GMP Certificate together with the following documents:
- legalized Power of Attorney from the applicant to the representative;
- legalized copies of the Manufacturer's Authorizations for all manufacturing sites involved in manufacturing process issued by the competent authorities of country-manufacturers;
- legalized copies of GMP Certificates for all manufacturing sites involved in manufacturing process issued by the competent Authorities of countries-manufacturers;
- certified copies of last reports on inspections of the manufacturing sites by the competent authorities of country-manufacturers or other competent authority that were conducted not earlier than 3 years before submitting the Application;
- certified copies of dossiers of the manufacturing sites involved in manufacturing process (Site Master Files);
- information on the revealed inconsistencies in the quality of medicinal products with the established requirements including the withdrawal of medicinal products from civil traffic for a period of at least 3 years prior to application;
- list of medicinal products produced (or planned to be produced) at the manufacturing site for which inspection is carried out;
- letter on the consent of the manufacturer for inspection.
Procedure of the conformity to the GMP requirements includes the following steps:
- submission of the application form and documents to obtain a certificate;
- inspection of manufacturing site;
- receipt of the GMP Certificate and/or report of compliance or non-compliance to the GMP requirements.
The GMP conformity assessment is conducted by the "Centre of Examinations and Tests in Health Service" by examination of provided documents and mandatory inspection of all manufacturing sites involved in manufacturing process of a medicinal product with the departure to the plant.
According to the demands of the Eurasian Economic Union inspection of manufacturing site should be conducted not later than 160 workdays from the date of submission of the application and the inspection period cannot exceed 10 workdays. However, in accordance with the usual practice depending upon the completion of the provided materials, scope of documentation, and other factors, the procedure of GMP conformity assessment in Belarus may constitute about 6-10 months.
The validity term of the GMP Certificate issued according to the demands of the Eurasian Economic Union is three years from the date of the end of the inspection.
In order we could provide you with the information on costs associated with GMP conformity assessment 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.