What is FMD

Falsified Medicines Directive

The Falsified Medicines Directive (FMD) and associated Delegated Regulation (DR) imposes new regulatory obligations on all pharmaceutical manufacturers, parallel distributors, marketing authorisation holders, community pharmacies, hospital pharmacies, GPs/ Health Centres and wholesalers since 9th February 2019 when the legislation came 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.

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 are 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.

Further information about FMD can be found at https://www.gov.uk/guidance/implementing-the-falsified-medicines-directive-safety-features

FMD and Brexit

The UK Dept of Health & Social Care (DHSC) and Medicines and Healthcare products Regulatory Agency (MHRA) have stated FMD and associated Delegated Regulation came into force on 9th February 2019 (see letter below) and the legislation will remain in force in the UK unless specifically revoked by parliament. SecurMed UK will continue to implement FMD 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 8 of the EU Withdrawal Agreement (25th November 2018) 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.

In the event of a No Deal Brexit, HM Government will withdraw the FMD legislation and all obliged stakeholders will no longer need to comply with FMD requirements in the UK. Serialised packs will still be accepted into the UK market as long as they meet MHRA local packaging requirements.

For further information please refer to the MHRA website or contact DHSC/MHRA at fmd.safetyfeatures@mhra.gov.uk.

Document Links

Letter from DHSC Minister to SecurMed Chair – April 2018
Annex I and Annex II Delegated Regulation

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 fmd.safetyfeatures@mhra.gov.uk.