Thursday, 13 June 2024 9 .00 - 17.30 h
Falsified medicines do not meet the standards of safety, efficacy and quality as are required and may pose a serious risk to public and animal health. That is why the topic is explicitly addressed in the EU GDP guidelines.
The EU GDP Guidelines (Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use - 2013/C 343/01) "lay down appropriate tools to assist wholesale distributors in conducting their activities and to prevent falsified medicines from entering the legal supply chain." According to Chapter 1.2., "the system for managing quality should encompass [...] activities necessary to ensure confidence that the product delivered maintains its quality and integrity and remains within the legal supply chain during storage and/or transportation." Chapter 5.1. requires that "the wholesale distributor should use all means available to minimise the risk of falsified medicinal products entering the legal supply chain."
Despite all precautions, several examples have recently come to light in which counterfeit medicines have entered the legal supply chain.
The European Medicines Agency (EMA) provides an overview on falsified medicines and links to further publications on its website. The European Commission also provides an outline on this subject.