Industry news

EU FMD 'Safety Features' Implementation

EFPIA, with the support of its European Stakeholder Model partners, signed a contract yesterday with IT service provider Solidsoft to implement the European Medicines Verification System (EMVS). See the EFPIA press release.

NOTE: There are currently two ‘track and verify’ systems being developed. One is the ‘European Stakeholder Model’ referred to above, which is the product of collaboration between the pharmaceutical industry (EFPIA), wholesalers (GIRP) and pharmacists (PGEU). This is based on a 2D barcode with a unique serial number and is designed around a central hub that will be linked to national or regional databases that pharmacists and others can use to check the authenticity of packs. The system was successfully trialled in Stockholm, Sweden, in 2009/10.

The other system is being developed by EDQM and is called eTACT. The eTACT system is at a much earlier stage of development and the reason for it being developed appears to be a desire by the European authorities to have the verification system under public governance.

I am not clear if this announcement means that the EMVS system is winning the battle between these two competing systems or not. EMVS was always several years ahead of eTACT in its development but these decisions are often made on political rather than technical grounds.