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MHRA Provides Guidance for Medicine Suppliers Supplying to Northern Ireland

on Monday, 07 February 2022.

The Medicines and Healthcare products Regulatory Agency (MHRA) is providing a series of guidance to help medicines suppliers to grapple with supplying into Northern Ireland (NI).

A major issue facing the pharma supply chain in the UK coming out of Brexit has been the impact of the NI Protocol and what this means for the ability to supply medicines to patients in NI. The NI Protocol had been introduced to deal with the situation where NI would have access to the EU's Single Market without a hard border in the island of Ireland, but in a way which noted that NI was still a part of the UK. The reality has been that the barriers have caused problems for supplies from Great Britain (GB) to NI.

Following the end of the Brexit transition period on 31 December 2020, there was a grace period covering supplies of medicines to NI, which had been due to expire on 31 December 2021.

However, given confusion and concerns for what it would mean for supplies coming from GB, suppliers started to withdraw supplies to NI as they did not see that it was worth their while having different arrangements for a relatively small market. Both the UK and EU sides wanted to avoid that, as ultimately patients in NI would suffer.

After months of discussions, where the UK had been proposing to withdraw medicines from the NI Protocol altogether, in December 2021 the Commission came up with an alternative proposal to amend EU law to accommodate the NI issue.

MHRA Guidance

The Commission proposal was published just before the Christmas break, so, despite an apparent solution, the detail has needed to be absorbed and worked through.

On 2 and 3 February, the MHRA ran webinars to help with the understanding of the latest position, and has promised to provide guidance to be published on its website very soon. Of particular note from the MHRA webinars:

  • The grace period that had been due to expire on 31 December 2021 will now last for one further year or until new law will replace it.
  • Since GB is a third country, after the end of the grace period, products coming from the EU to GB were going to be required to be decommissioned for Falsified Medicines Directive (FMD) purposes before entering GB. However, that requirement has been put back for three years.
  • The UK is going to consult on a new system to replace FMD in the UK.
  • The MHRA is setting out ways in which GB only marketing authorisations can be converted to UK-wide applications - provided that any UK-wide applications have to still comply with FMD requirements for the unique identifier and anti-tamper device safety features (and even if the products do not get supplied to NI but remain in GB). The MHRA is providing guidance for how and where to submit changes to applications from GB to UK wide.
  • In addition, the MHRA is providing guidance on how people wanting to supply across the UK can move from an EU Mutual Recognition / Decentralised Procedure licence (for NI) to a UK-wide licence, and who to notify and how.
  • Under the new rules, wholesale dealers authorisation holders can bring products into NI from GB if they have been certified and released by a qualified person anywhere in the UK or the EU, and they comply with FMD requirements, plus the products are made available in NI rather than onward supply to other EU Member States.
  • The Commission proposal also allows for qualified persons for pharmacovigilance to be based in GB for products made available in NI through the EU Mutual Recognition / Decentralised Procedure.
  • The Commission proposal further does not require re-testing for EU-authorised products that had been imported from the EU to GB for onward supply to NI, as long as the testing had been done previously in the EU.

Looking Ahead

This continues to be a very complex area and an on-going legacy from Brexit. Judging by the complexity of issues covered in the MHRA webinars and the scope of the questions, a lot of detail needs to be fully explained and understood. To that end, suppliers will look forward to the further guidance documents being published from the MHRA. The MHRA will also be providing an FAQs document in due course.


If you have any comments on this issue, please contact Paul Gershlick in our Pharmaceuticals and Life Sciences team on 07795 570072, or complete the form below.

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