System to fight counterfeit medicines must be up and running in three years

Lääketeollisuus ry

A more detailed timetable for the implementation of the European medicines verification system EMVS was specified on Tuesday 9 February as the European Commission issued the Delegated Regulations related to the counterfeit medicines Directive. 

The medicines verification system currently under construction must be in operative use by February 2019 when the three-year implementation period expires.

The purpose of the system is to prevent counterfeit medicines from reaching patients via the legal distribution channel, in other words pharmaceutical wholesalers, pharmacies and hospitals. This happens with the help of the pan-European database and an individual code on each medicine package. 

The database and unique identifiers make it possible for the pharmaceutical actors to verify that only legal medicinal products with the appropriate marketing authorisation enter the pharmaceutical chain.

Medicine packages will also be provided with features, such as seals or strip packages, which will reveal eventual tampering.

All actors in the medicines chain from pharmaceutical manufacturers to wholesalers and pharmacies contribute to the setting up of the medicines verification system. The pharmaceutical industry carries the main responsibility and expenses for the project.

Counterfeit medicines constitute a serious health risk for medicine users and public health. In Finland, counterfeits enter the legal distribution channel only rarely while on a global scale they constitute a major problem. Counterfeit medicines find their way to Finland mainly through Internet orders but also through people who have bought them abroad.

For further information:

Maija Gohlke-Kokkkonen, Senior Advisor

Pharma Industry Finland PIF

Tel: +358 40 700 1655

15. Feb 2016