The purpose of the EMA Certificates of Medicinal Products scheme is to support the work of Health Authorities outside the European Union. The EMA certificates are issued by the Agency, on behalf of the European Commission, to confirm the Marketing Authorization status of products either authorized by the European Commission through the centralsied procedure or products for which a centralsied application has been submitted to the agency. The certificates also confirm the Good Manufacturing Practice (GMP) compliance status of the manufacturing site's producing the medicinal product bulk pharmaceutical form.
The EMA can certify a product only if the valid application for marketing authorization or for the scientific opinion has been submitted to the agency via the centralsied procedure.
The agency can issue Certificates of Medicinal Products to support the work of Health Authorities in any country outside the European Union. Guidance on countries officially recognized by the European Union, their official names used can be found in the list of countries and territories.
Further information:
No comments:
Post a Comment