In accordance with the Decision of the Council of the Eurasian Economic Commission of November 03, 2016, No. 78, registration of medicinal products produced outside of the member states (Russia, Belarus, Kazakhstan, Kyrgyzstan or Armenia) of the Eurasian Economic Union (the EAEU) is possible only subject to GMP conformity assessment of all manufacturing sites involved in manufacturing process by one of the member states of the EAEU.
Required documents
In order to conduct a GMP conformity assessment according to the demands of the EAEU legislation, it is necessary to provide an 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 Manufacturer's Authorizations for all manufacturing sites involved in the manufacturing process issued by competent authorities of ;
- legalized copies of GMP Certificates for all manufacturing sites involved in the manufacturing process issued by competent authorities of countries of manufacture;
- certified copies of the latest reports on inspections of the manufacturing sites by competent authorities of countries of manufacture or other competent authority that were conducted not earlier than 3 years before submission of the application;
- certified copies of dossiers of the manufacturing sites involved in the manufacturing process (Site Master Files);
- information on revealed inconsistencies in quality of medicinal products with the established requirements including withdrawal of the 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 the inspection is carried out.
Procedure
GMP conformity assessment procedure includes the following steps:
- submission of the application and documents to obtain a certificate;
- inspection of the 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 a corresponding responsible Authority of the reference member state by means of examination of provided documents and mandatory inspection of all manufacturing sites involved in the manufacturing process of the medicinal product with departure to the plant.
Timeframe
In accordance with the usual practice, depending on completion of the provided materials, scope of documentation, and other factors, the procedure of GMP conformity assessment may constitute about 6-10 months.
Validity term
Validity term of the GMP Certificate issued according to the EAEU procedure is three years from the date of the end of the inspection.
For more detailed information, including the costs associated with GMP conformity assessment in the member states of the EAEU, list of documents required for submission, as well as a sample of the Power of Attorney for execution, etc. please contact our specialists.
