The European Medicines Verification Organisation (EMVO) has announced that the European Medicines Verification System (EMVS) is now live across the EU. The system, the first of its kind, is a big step in the prevention of falsified medicines illegally entering the supple chain.
Coming into effect on 9 February 2019 with the intent of securing the European medicine supply chain and protecting patients, the EMVS is mandated by the EU Falsified Medicines Directive and managed by a consortia of stakeholders including the European Federation of Pharmaceutical Industries and Associations, Medicines for Europe and the European Association of Hospital Pharmacists amongst others.
The EU Directive a associated regulation states that there must be two new safety features on medicine packaging introduced. The new features would “allow the verification of the authenticity and the identification of each individual pack”.
EMVO
EMVO stakeholders at the EMVS press briefing
The legislation states that pharmaceutical companies and importers are now required to print a Data Matrix code on the medicine pack. Inside the code is a Unique Identifier, consisting of a random serial number unique to each pack and product code. This Unique Identifier is uploaded to the EMVS hub by manufacturers. Information about the expiry date and batch number is also included in the Data Matrix.
Pharma companies and importers must also apply an anti-tampering device to the outer packaging for each individual sales package.
Throughout the supply chain, wholesalers and other stakeholders will scan the data matrix using specially designed software in order to check its authenticity.
When the medicine is dispensed to the patient, the Unique Identifier will be scanned and decommissioned from the EMVS database by the pharmacist as a final safety check.
The EMVS is intended to protect both patients and the pharmaceutical industry by assuring end to end authenticity.
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