Falsified Medicines Directive and European Medicines Verification System Update

IDMP1 Newsletter January 2018

The Falsified Medicines Directive places the EU Commission under an obligation to adopt a delegated act setting out the details of the safety features, including how medicine authenticity should be verified and by whom. The information gathered from a public consultation was used as the basis for an impact assessment by the European Federation of Pharmaceutical Industries and Associations (EFPIA).

All EU Markets (Greece, Belgium and Italy excepted) have to implement the Directive latest by 9. February 2019.

SAFETY FEATURES FOR MEDICINAL PRODUCTS FOR HUMAN USE QUESTIONS AND ANSWERS

(Version 5 published June 2016)

A Q&A Section can be found at https://ec.europa.eu/health//sites/health/files/files/falsified_medicines/qa_safetyfeature_v5_0.pdf

How does IDMP come in?

As described in EFPIA’s presentation “EU IDMP Taskforce – Falsified Medicines Directive and European Medicines Verification System Update” from February 2016, the European Medicines Verification System is another solution that will use SPOR-OMS as well as RMS data. See also our blog on the Electronic Application Form (eAF), Falsified Medicines and the Clinical Trials Portal.