What is FMD
Falsified Medicines Directive
The Falsified Medicines Directive (FMD) and associated Delegated Regulation (DR) impose regulatory obligations on all pharmaceutical manufacturers, parallel distributors, marketing authorisation holders, community pharmacies, hospital pharmacies, GPs/ Health Centres and wholesalers to be ready by 9th February 2019 when the legislation comes into force.
The scope of FMD covers all prescription only medicines (POMs) as set out in regulation 2016/161/EU. Exceptions to the regulation for some medicines are listed in Annex I and Annex II Delegated Regulation (see doc link below).
Manufacturers, parallel distributors and marketing authorisation holders 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 into a Europe-wide database for verification and decommissioning of medicine packs by end users. Manufacturers, parallel distributors and marketing authorisation holders are required to fund the establishment and operation of SecurMed UK and the UK Medicines Verification System.
Community pharmacy, hospital pharmacy, GPs/ health centres and pharmaceutical wholesalers are required to make changes to their business process and IT systems to enable them to verify and authenticate medicines as they travel through the supply chain to dispense to patients. IT system changes will be required to create a connection to the UK Medicines Verification System. There are no costs for wholesalers, community pharmacies, hospitals, GPs/health centres and wholesalers to use the UK system.
FMD and Brexit
The UK Dept of Health & Social Care has stated FMD will be implemented and enforced as of 9th February 2019 (see letter below) and the legislation will remain in force in the UK unless specifically revoked by parliament. In addition MHRA have issued the UK Public Consultation on FMD with draft legislation for implementation in February next year. SecurMed UK are continuing to prepare for full FMD implementation as part of the EU programme unless otherwise advised by the UK Dept of Health & Social Care.
DHSC and SecurMed UK are aware that Article 7 of the EU Withdrawal Agreement states that the EU and UK will disconnect all shared systems at the end of any agreed Brexit transition period and also that the EU Commission has separately stated, in an answer to Switzerland, that countries outside EEA cannot participate in FMD. These are known risks and SecurMed will be taking guidance and direction from DHSC/MHRA on the UK continuation within the EU FMD programme as the outcome of Brexit negotiations becomes known.
Letter from DHSC Minister to SecurMed Chair – April 2018
Packaging & Labelling Changes and Medicines in FMD Scope
SecurMed UK cannot provide guidance on the regulatory obligations or on how packaging changes should be applied. Where manufacturers and parallel distributors are unclear on the proposed legislation, for example – for guidance on changes to packaging and labelling, or whether certain types of medicine are in/out of scope of the FMD implementation, please contact DHSC/MHRA at firstname.lastname@example.org.