The Regulatory and Procedural Guideline of the European Medicines Agency (EMA) on Certificates of Medicinal products – Instructions on how to fill the Application Form has been adopted.

The certificates are issued by EMA, on behalf of the European Commission, to confirm the Marketing Authorisation status of products either authorised by the European Commission through the centralised procedure or products for which a centralised 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.

Guideline.pdf

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