CRED Getting the CMC Dossier Right 2024

28/08/2024

Falsified Medicines Directive

GMP obligations: ● From 2 January 2013 – all active drug substances have to be manufactured in accordance with EU GMP or equivalent (if imported)

● From 2 July 2013 – all actives drug substances manufactured outside the EU have to be accompanied by a Written Confirmation from Regulatory Authority of country of origin

The Organisation for Professionals in Regulatory Affairs

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Falsified Medicines Directive

Alternatives to Written Confirmation:

● List of “Third countries” with comparable inspection standards e.g. Switzerland and Australia

● Requirement can be waived by a MS if it has inspected the plant and found it compliant.

The Organisation for Professionals in Regulatory Affairs

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