Delegated act

The delegated act (Commission Delegated Regulation (EU) 2016/161) detailing the characteristics of the safety features, how medicine authenticity should be verified, and by whom, was adopted on 2nd October 2015 and published, after scrutiny by the European Parliament and the Council, on 9th February 2016.

Delegated Regulation 2016/161/EC lays down, that it must be possible to identify and verify the authenticity of an individual pack of a medicinal product for the entire time the medicinal product stays on the market and the additional time necessary for returning and disposing of the pack after it has expired.

The delegated Regulation, and the new medicine verification system it lays down, will apply as of 9th February 2019.