Draft of Delegated Act regarding Safety Features published

The European Union has published the draft of the delegated act. This document deals with the technological and organisational requirements for the safety features that have to be considered in the future for prescription medicines in accordance with the counterfeiting directive.

The document contains 34 pages, and, in addition the Annexes I - IV.

In the future a system is proposed to be established which ensures the identification and authentication of medicinal product by an "end-to-end" verification. For certain medicinal products with a higher counterfeiting risk additional verifications are proposed to take place at the wholesalers.

As characteristic a two-dimensional (2D) barcode is supposed to be used - which must be attached to the packaging in readable form.

The monitoring authorities will also be allowed to get access to the information regarding the security characteristics of the medicinal product.

Chapter I defines which medicinal product must bear this safety feature. The technical specifications are presented in Chapter 2. The two-dimensional bar code shall comply with at least the quality of the data matrix code ECC200 and shall be of adequate quality. The more detailed requirements can be found in Chapter 6.

For further details please see the complete draft of the Commission Delegated Regulation (EU).

Go back


Stay informed with the GMP Newsletters from ECA

GMP Newsletter

The ECA offers various free of charge GMP newsletters for which you can subscribe to according to your needs.

To subscribe, please click here.