Draft of Delegated Acts describing the details of safety features published


European Commission has published a draft of Delegated Acts that describe the details of safety features of medicine packs introduced in the falsified medicines directive. The draft describes technical specifications of the unique identifier, how the safety features should be verified, set-up, management and accessibility of repositories system and white list and black list. After publication of the Delegated Acts in the Official Journal of the European Union approximately in the beginning of 2016 there will be three years implementation time. As a member of Pharma Industry Finland Medfiles will actively follow the discussions with Fimea on impact of the regulations on marketing authorisations. Thus Medfiles is willing to give advice and help for marketing autohrisation holders with the implementation of the safety features.

Please contact Operative Director Anu Gummerus by phone +358 40 723 7031 or by email expert@medfiles.eu.

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