Description

 This draft Commission Delegated Regulation sets out the detailed rules for the implementation of obligatory safety features (a unique identifier and an anti-tampering device) to prevent the entry of falsified medicines in the legal supply chain in the Union.The delegated act provides for, inter alia: The harmonised structure and content of the unique identifier as well as its carrier, across the EU.The setting up of an “end-to-end” system for the verification of the authenticity of the safety features complemented by risk-based checks at wholesaler level. In practice, the safety features placed on a medicine pack by the manufacturer are systematically verified for authenticity at the end of the supply chain, before that pack is dispensed to a patient (e.g.: by pharmacies or hospitals). The authenticity of medicines at higher risk of falsification is additionally verified in the middle of the supply chain by wholesalers.The setting up, management and supervision of a repositories system where legitimate unique identifiers are stored. The repositories system is to be set up and managed by stakeholders, under the supervision of Member States competent authorities. The repositories system is queried in order to verify the authenticity of the medicinal product.