European Association of Euro-Pharmaceutical Companies

The Falsified Medicines Directives' Delegated Regulation on the safety features has been officially adopted on 2nd October 2015.

The European Commission has forwarded it to the European Parliament and Council. With the move, day "0" has now been launched and a scrutiny period of 2 months for the European Parliament and Council starts running. Publication of the Delegated Regulation can therefore be expected in mid-December 2015 or in mid-February 2016, should the European Parliament or Council decide to extend the scrutiny period to 4 months.