Delegated Regulation on the Anti-Counterfeiting Directive - New EU Requirements and State of Implementation

On 9 February 2016, the European Union published the "Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use" in the official journal of the European Union - please also see Publication of the Delegated Regulation on the Anti-Counterfeiting Regulation.

The most important consequence of this publication is that now all the requirements and technical details on serialisation and verification of medicinal products (safety features needed) are known.  As of 9th February 2019, only prescription medicines meeting additionally - where applicable -  the requirements laid down in the Delegated Regulation will be marketable.

The interpretation of the Delegated Regulation's official texts is not always easy. That's why the European Commission published an additional Questions and Answers catalogue which is - in the meantime - available in version 5.0 from June 2016.

A few new questions and answers have been included so that the document now contains 57 questions and answers in total on the safety features.

The securPharm initiative was created to protect patients from counterfeit medicines in the legal supply chain in Germany and to support the implementation of the European Counterfeit Directive. Since 2011, the initiative has been elaborating a system of protection from counterfeit medicines in anticipation of the expected regulations. This system has been tested since 2013. SecurPharm's view is reinforced in its fundamental cornerstones by the Delegated Regulation published in February 2016. The system already largely complies with the European guidelines.

According to the securPharm Status Report 2017 presenting the current status of the project, 100 pharmaceutical companies are now participating (as of December 2016). Among them, both large international companies as well as midsize companies can be found.

As a conclusion it is stated at the end of the report that it is of the utmost urgency for pharmaceutical companies to confront themselves with the technical and organisational challenges related to the implementation of the EU Counterfeit Directive. One of the biggest challenges is the change of the company's internal processes as almost all processes have to be adapted.

For more details please see the complete securPharm Status Report 2017.

And here to open version 5 of the EU Commission's Questions and Answers document on safety features.