What is the FMD?
Since 9th February 2019, the Falsified Medicines Directive (FMD) and associated Delegated Regulation (DR) have imposed new regulatory obligations on all organisations that manufacture and/or dispense prescription-only medicines (POMs)*. This includes, but is not limited to:
*Exceptions to the regulation of some medicines are listed in Annex I and Annex II Delegated Regulation.
Manufacturers, Parallel Distributors and MAHs are required to make changes to their POM packaging and labelling to add anti-tamper proof devices, additional human-readable information, and a 2D machine-readable matrix to enable scanning of medicines.
In addition, they are required to upload the human-readable information to a Europe-wide database for the verification and decommissioning of medicine packs by End Users.
Manufacturers, Parallel Distributors and MAHs are also required to fund SecurMed and the UKNI Medicines Verification System (UKNI MVS).
Community Pharmacies, Hospital Pharmacies, GPs and Health Centres, and Wholesalers are required to adapt their business processes and IT systems to verify and authenticate medicines through the whole supply chain. IT systems also need to be able to connect to the UKNI MVS. There is no cost for dispensers to use the UKNI MVS.
For further guidance, please see the GOV.UK FMD Safety Features.
Please note: SecurMed cannot provide guidance on the regulatory obligations or how packaging changes should be applied. If you are unclear on the legislation, please contact the Medicines and Healthcare products Regulatory Agency (MHRA).