Falsified Medicines Directive
Counterfeiting of medicines is a serious criminal act that puts people's lives at risk. To address this the EU Falsified Medicines Directive (2011/62/EU) (FMD), introduces new safety features on many medicines in the European Union (EU) to ensure that the authenticity of these medicines can be verified before supply to the patient.
The Delegated Regulation comes into force on 9th February 2019 and it will require safety features to be on the packaging of many medicines from that date onwards.
All Marketing Authorisation Holders are required to place two safety features on the packaging of most Prescription Only Medicines. The first safety feature is a unique identifier encoded in a 2D data matrix code and printed in a human readable format and the second is an anti-tampering device. Each unique identifier will be uploaded by the Marketing Authorisation Holder into “National Medicines Verification Systems”. Wholesalers and persons authorised or entitled to supply medicinal products to the public shall verify and, on supply to the patient, decommission the unique identifiers by scanning the 2D data matrix code which will be checked against data in the National Medicines Verification System.
The unique identifier comprises:
• a product code which allows the identification of the name of the medicine, the pharmaceutical form, the strength, the pack size, and the pack type
• a serial number which is a numeric or alphanumeric sequence of a maximum of 20 characters randomly generated
• a batch number
• an expiry date
• a national health reimbursement number (required by some countries)
The scope of the FMD covers all Prescription Only Medicines except those listed in Annex I:
Further information about the FMD can be found at https://emvo-medicines.eu/
For enquiries relating to specific unique identifiers, please send us an enquiry using the form here