(Suspected) falsified medicinal product report

8 février 2019


As of 9 February 2019, marketing authorised holders are obliged to place two safety features on the packaging of most prescription medicines and some over-the-counter medicines in the European Union : a unique identifier (a 2-dimension barcode) and an anti-tampering device, in accordance with Commission Delegated Regulation (EU) 2016/161. The annexes of the regulation include the list of medicines subject to this requirement. Manufacturers will upload the information contained in the unique identifier for each individual medicine to a central EU repository. The repository is part of an end-to-end medicines verification system introduced by the Regulation. Depending on the source of the medicine, wholesalers will also need to scan medicines at different points in the supply chain to verify their authenticity. Pharmacies and hospitals will then scan each medicine at the end of the supply chain to verify their authenticity and check them out from the repository before dispensing them to patients. These safety features will guarantee medicine authenticity for the benefit of patients and businesses, and will strengthen the security of the medicine supply chain, from manufacturers to distributors, pharmacies and hospitals.


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