[securPharm e. V. - a protective shield against falsified medicines]

Area of Science:

• Pharmaceutical regulation and public health
• Drug safety and supply chain integrity
• European Union legislation impacting healthcare

Background:

• The Falsified Medicines Directive (2011/62/EU) aims to combat the increasing threat of counterfeit pharmaceuticals.
• EU Regulation 2016/161 mandates safety features and authentication for prescription drugs from February 9, 2019.
• National Medicines Verification Organisations (NMVOs) are required in each EU member state to manage national verification systems (NMVS).

Purpose of the Study:

• To provide an overview of the project progress of securPharm e.V., the German NMVO.
• To detail the implementation of the national medicines verification system in Germany.
• To highlight the measures taken to identify and prevent falsified medicines in the pharmaceutical supply chain.

Main Methods:

• Establishment of securPharm e.V. as the German NMVO, an alliance of industry, wholesalers, and pharmacies.
• Development and implementation of a national medicines verification system (NMVS) for pharmaceutical authentication.
• Phased rollout and testing of the securPharm system for pharmaceutical companies, wholesalers, and pharmacies since 2013.

Main Results:

• securPharm e.V. was established in 2011 and has been operational for testing purposes since 2013.
• The system is designed to comply with the Falsified Medicines Directive and EU Regulation 2016/161.
• As of June 2017, the project was progressing towards full implementation of the verification system.

Conclusions:

• The implementation of securPharm's NMVS is crucial for enhancing patient safety in Germany.
• The system provides a standardized solution for authenticating prescription drugs, thereby combating falsified medicines.
• Successful authentication of pharmaceuticals through the NMVS will ensure compliance with EU directives and regulations.