To the attention of interested parties
The European Commission, the European Medicines Agency (EMA) and national competent authorities of EU Member States have adopted measures meant to help protect patients against the threat of falsified medicines, which may contain ingredients, active substances included, which are of low quality or in the improper dosage.
A new Commission Delegated Regulation establishes detailed standards for safety features to be placed on the packaging of medicines for human use. The safety features consist of a unique identifier (a 2-dimension barcode) and an anti-tampering device, to be placed on the packaging of certain medicines for human use, allowing for their identification and authentication.
Introduction of the safety features in question will prevent falsified medicines entering the legal supply chain, from manufacturers to distributors to pharmacies and hospitals, respectively, thus guaranteeing medicine authenticity.
Marketing-authorisation holders are required to place the safety features on the packaging of most prescription medicines as well as of certain non-prescription medicines no later than 9 February 2019.