Notification Detail

 Draft Commission Delegated Regulation supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the outer packaging of medicinal products for human use (34 pages of main document + 5 pages of Annexes, in English)
Reference: G/TBT/N/EU/306

Date of arrival: 2015 August 12     -     Final date for comments: 2015 October 11


 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.


Protection of Human Health or Safety

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Draft Text 1 is available for download in the following languages:
Draft Text 2 is available for download in the following languages: