For some time, the European Federation of Pharmaceutical Industries and Associations (EFPIA) has been working on developing a European verification system to help combat falsified medicines. The system, the European Medicines Verification System (EMVS), now seems close to implementation as EFPIA has launched a tendering process to select potential vendors for the technology.
The EMVS involves individually marking medicine packs with a unique code at the point of manufacture. The code is then verified in the pharmacy prior to release of the pack to the patient. According to EFPIA, the solution will provide end users with more confidence in the pharmaceutical supply chain and its products. In addition, the system establishes the routine activities of using serial numbers and verification, which are required by the EU Falsified Medicines Directive. Member states will have to apply the measures outlines in the directive from January next year.
The EMVS was piloted in Sweden between 2009 and 2010, and was shown to be effective in identifying fake medicines. In addition, the system’s availability and performance seemed good: pharmacists could work at a normal pace without significant extra effort and the system provided a response in less than half a second for 95% of transactions. According to a document published on EFPIA’s website, pharmacists and wholesalers found that having the expiry date and batch number in a machine-readable format particularly valuable.
One issue that was flagged, however, was that it was essential that each pack only have one code because the presence of more than one caused confusion to the user.
The EMVS will build on the learnings from the pilot phase and EFPIA is looking to demonstrate the system’s efficiency and viability through real-life implementation before the European Commission publishes its Delegated Act on Safety Features in connection with the Falsified Medicines Directive, which is expected in 2014. According to a statement, EFPIA believes that the EMVS is “likely to constitute the key solution for future implementation of the Falsified Medicines Directive”.
The tender process for vendors will comprise several steps and decisions will be based on the fact that the implementation phase and future roll-out phases of the full EMVS will be commercially completely independent.
The shortlist of candidate vendors will be issued on 15 June.