The EU Falsified Medicines Directive (FMD, Directive 2011/62/EU) and its Delegated Regulation (EU) 2016/161 require prescription medicines sold in the EU to carry a unique identifier (UI) and tamper-evident features. The UI must be verified against the European Medicines Verification System (EMVS) at the point of dispensing. FMD has been fully implemented since February 2019.
Unique Identifier Requirements
The FMD unique identifier must contain: a product code (identifying the medicinal product, pharmaceutical form, strength, pack size, and pack type); a serial number (randomised numerical or alphanumerical sequence of maximum 20 characters); a national reimbursement number (where applicable); a lot number; and an expiry date. The UI must be encoded in a 2D DataMatrix barcode.
Tamper-Evident Features
All prescription medicines must carry tamper-evident features that allow verification that the packaging has not been opened. Acceptable features include: breakable caps; shrink wrap; induction seals; and blister packs with printed foil. The tamper-evident feature must be visible and must not be repairable after opening.
EMVS Architecture
The European Medicines Verification System (EMVS) is a pan-European repository of unique identifiers. It consists of: the European Hub (managed by EMVO); 27+ national medicines verification systems (NMVSs); and end-user systems at pharmacies, hospitals, and wholesalers. Manufacturers upload UIs to the European Hub, which distributes them to NMVSs. Dispensers verify UIs against their national NMVS at the point of dispensing.
Exemptions
Over-the-counter (OTC) medicines are generally exempt from FMD serialisation requirements, with the exception of OTC medicines that are at high risk of falsification (to be determined by the Commission). Hospital exemptions allow hospitals to verify medicines at the point of administration rather than dispensing in some member states.