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.
EMA also certifies products pursuant to art. 58 of Regulation (EC) No. 726/2004: Art. 58 provides that the Agency can give a scientific opinion, in the context of cooperation with the WHO, for the evaluation of certain medicinal products intended exclusively for markets outside the European Community.
EMA issues certificates within 10 working days following receipt of a valid application form. To give guidance on how to fill this application form, the new guideline has been developed.
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)