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.
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.
Falsification of Ozempic: Following the recent concerns that falsified batches of Ozempic® may have entered the market, the Official Medicines Control Laboratory (OMCL) Chemisches und Veterinäruntersuchungsamt (CVUA, Karlsruhe, Germany) has determined that suspected batches of Ozempic® pre-filled pens contained insulin glulisine instead of the claimed active substance, semaglutide. Falsified Ozempic pens have also been identified at two wholesalers in the UK.
Falsification of medical devices: Falsification affects not only pharmaceuticals, but also medical devices. In this regard, the Committee of Experts on Minimising Public Health Risks Posed by Falsification of Medical Products and Similar Crimes (CD-P-PH/CMED) carried out a survey on how authorities in Council of Europe member states perceive and address the issue of falsification of medical devices. The results are available in a report.