CRED Getting the CMC Dossier Right 2024

28/08/2024

Falsified Medicines Directive

Directive 2011/62/EU – published July 2011

Key objective is to address problem of increase in falsified medicines found in EU by:

● Improving controls on quality of active substances and excipients

● Requiring safety features for medicines at risk of counterfeiting

● From July 2013, all APIs manufactured outside the EU and imported into the EU must have an EU GMP equivalence statement from the regulatory authority of the exporting country (Certification per site, per substance).

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:174:0074:0087:EN:PDF

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Falsified Medicines Directive

● Regulating medicines imported for re-export (new term - “introduced”) and rules governing access to medicines held in free trade zones & warehouses

● Strengthened obligations on wholesale dealers and extending regulation to brokers of medicines

● Addressing internet supply of medicine

● Strengthening inspection and ensuring appropriate penalties for counterfeiting are in place in Member States

The Organisation for Professionals in Regulatory Affairs

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