EMA's Provisions regarding the Implementation of the Counterfeit Directive

In our GMP News Important Publication of the Delegated Regulation complementing the Anti-Counterfeiting Regulation we already informed about the publication of the Delegated Regulation. Now, the date for the implementation of the safety features is mandatory: February, 9th 2019.

This EU Delegated Regulation on the implementation of the anti-counterfeiting regulation will have direct impact on the marketing authorisation of medicinal products. For this, the EMA has published an implementation plan for the introduction of the safety features. Marketing authorisation holders are recommended to use a regulatory procedure which has to be performed anyway for another reason like for example an upcoming authorisation renewal. The procedure should also be used to communicate the safety features information to the competent authority.

Furthermore, the EMA has published an updated template of the Quality Review of Documents Group (QRD) for specialised information,  package leaflets and labelling.

The updated document now contains two new paragraphs in the section " Labelling":

17. Unique identifier - 2D barcode
18. Unique identifier - human readable data

To get more details please access EMA's "Implementation Plan for the Introduction of the Safety Features on the Packaging of centrally authorised Medicinal Products for human use".