What is the FMD?

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:

  • Manufacturers
  • Parallel Distributors
  • Marketing Authorisation Holders (MAHs)
  • Community Pharmacies
  • Hospital Pharmacies
  • GPs and Health Centres
  • Wholesalers

*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).

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EU Exit and UK MVS

The United Kingdom Transition Period ended on 31st December 2020 and the UK became a third country in relation to the EU.

Where can I find a copy of the Delegated Regulation?

You can find the Delegated Regulation here.

Which medicines are in scope of FMD?

For details of the scope of the regulation please check: FMD Delegated Regulation 2016_161

Where stakeholders are unclear on the legislation, for example whether types of medicine are in/out of scope, please contact DHSC/MHRA at fmd. safetyfeatures@mhra. gov. uk.

Will anti-tamper devices be allowed on OTCs and other out-of-scope products after February 2019?

The MHRA has confirmed that subject to the outcome of a public consultation anti-tamper devices may continue to be placed on out-of-scope products after 9th February 2019 if the relevant manufacturer considers that it is necessary to do so in the interests of patient safety.

If you have independent subsidiaries across one hospital trust, does each subsidiary need to be registered separately to the hospital in which it is located?

Please check which location(s) are registered with the relevant professional or sectoral body (such as PSNI). SecurMed will provide individual credentials for each Location that is individually registered with the relevant body.