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Warning given by France's medicines regulatory authority of fake GMP certificates

According to France's medicines regulatory authority s, companies are selling active pharmaceutical ingredient (APIs) with forged documents. Several cases of falsified [Good Manufacturing Practice] GMP certificates under its letterhead for import and export activities of active substances have been informed to the regulators.

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.

Due to rising cases of such falsified GMP certificates, the French regulators have asked the stakeholders to check the authenticity of GMP certificates on EudraGMDP Community database."


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