On the 9th of February 2019, Regulation 2016/161 of the European Commission on the safety features to be included on the packaging of medicinal products for human use came into force.
This Regulation foresees measures to prevent the entry of counterfeit medicines into the legal supply chain and more specifically introduces the certification of the authenticity of medicines through two security features:
• a unique identification code that allows the authenticity of a pharmaceutical product to be verified. This unique identification code identifies a given medicine package and is encoded in a two-dimensional barcode that can be read by common scanners.
• a counterfeiting detection mechanism that ensures that the drug packaging is not opened or tampered with.
The presence of the above safety features is mandatory for most prescription drugs and for some over-the-counter medications. Exceptions to the existence of safety features are some categories of drugs such as homeopathic medicines, radiopharmaceuticals, advanced medicinal products, medical gases and contrast agents.
The system of certification of the authenticity of medicines introduces the verification, from beginning to end of the supply chain, of prescription medicines sold in the EU.
As a first step, manufacturers upload the above information contained in the unique identification code and each individual medicine into the EU's central repository managed by the European Medicines Verification Organisation.
Then, depending on their source, wholesale licence holders scan the medicines at various points in the supply chain to verify their authenticity.
Finally, pharmacies and hospitals scan all medicines at the end of the supply chain to verify their authenticity and to remove them from the repository before making them available to patients.
Under the new regulation, medicines are subject to systematic certification of authenticity before they are made available to patients, thus preventing not only the administration of counterfeit drugs but also other problems, such as the inadvertent administration of expired or withdrawn drugs, protecting in this way public health.