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.
The United Kingdom Transition Period ended on 31st December 2020 and the UK became a third country in relation to the EU.
You can find the Delegated Regulation here.
Please consult the UK government website.
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.
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.
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.