Brief: French drugs regulator warns of fake API certificates

France's medicines regulatory authority says it appears unscrupulous companies are selling active pharmaceutical ingredient (APIs) with forged documents.

The ANSM says it has been informed of "several falsified [Good Manufacturing Practice] GMP certificates under its letterhead for import and export activities of active substances."

Since July 2013 the EU authorities have required a GMP certification for every API imported into the EU. The certification should be issued by competent authority of the exporting country. Under the requirements, the Qualified Person (QP) of the finished product manufacturing authorization holder must sign a declaration stating that the API is manufactured in compliance with GMP.

Because of a recent increase in observed cases, the ANSM "reminds stakeholders that the authenticity of GMP certificates should be checked on EudraGMDP Community database."

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