Positive Balance for Implementation of the Falsified Medicines Directive

Recommendation

Tuesday, 8 June 2027 13.00 - 16.00 h

Drug Shortage Policy in the EU: How to deal with Regulatory Requirements? - Live Online Training
The EMA Guidance on Medicine Shortages and Availability Issues and the European Shortages Monitoring Platform (ESMP)

All European requirements for the serialisation and verification of medicinal products concerned must be implemented by February 09, 2019.

The initiative securPharm, which was founded in order to protect patients from falsified drugs in the legal supply chain of Germany, has been developing a system to protect against counterfeit drugs as per European requirements since 2011. This has been tested in practice since 2013.

At the mid-term of the project, securPharm struck a positive balance. The development of the new falsification protection is going well. securPharm expects to accomplish building a functioning safety system by February 09, 2019.

Challenges for the next term as seen by securPharm are the further building of the system as well as the connection of system users. This includes not only pharmaceutical supply partners, but also competent national authorities.

Meanwhile, 148 pharmaceutical companies are involved (as of 08/2017).

The outlook with regards to other EU member states and member states of the European Economic Area makes securPharm more optimistic than at the beginning of the year, as well.

You can find more details in the complete securPharm press release (in German).