What are the current positions of the European Commission and UK Government with respect to plans for EU FMD in Northern Ireland from 1st January 2022?

The European Commission published a non-paper on “Medicines and the implementation of the Protocol in Ireland and Northern Ireland” in July 2021.  

The UK Government responded with a Command Paper on “Northern Ireland Protocol: the way forward”. 

Negotiations are continuing between the parties on the outcomes to be implemented from 1st January 2022.

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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.