With only 10 days until the end of the transition period between the UK and EU, the lack of guidance in key areas is making it difficult for pharmaceuticals and device companies to prepare for the new rules in 2021. The MHRA themselves have identified that guidance on the following areas will be published “soon”:

  • Advice for Northern Ireland retailers on devices
  • Advice for NI retailers on medicines
  • Distance selling logo
  • PSMF Location Guidance
  • UK MAH requirements for non-UK based MAH
  • Guidance on Rolling Review for Marketing Authorisation Application
  • Guidance on 150-day Assessment for National Applications
  • Guidance on Unfettered Access Procedure
  • Guidance on MR/DC Reliance Procedures
  • Guidance on EC Decision Reliance Procedure

Obviously with it being so close to the end of the transition period, even if guidance was published in the coming days, it will be difficult to implement any changes in time for the end of the year deadline.

It is difficult to get too frustrated with the regulators, this is an ongoing political issue.

We know the MHRA are currently preparing a Q&A document, where they have condensed 3000 questions from industry into a consolidated 150 Q&A advice document. This is due to be published any moment.

We have however received industry interpretation of the guidance regarding the supply of medicines to Northern Ireland:

  • Up until 31st December 2021, medicines can be supplied from Great Britain (GB) to NI applying EU rules on importation and unique identifier requirements.

Outside of these two areas, medicines supplied to NI have to follow EU rules.

  • Batch testing and QP certification will continue to be required to place a product on the UK market. Additionally, up until 31st December 2021:
    • Batch testing and QP certification done in GB (England, Wales and Scotland) will enable supply to NI
    • Batch testing and QP certification done in EU will also enable supply to NI via GB
    • Medicines supplied from GB to NI will not require additional regulatory import controls (manufacture and import authorisation, batch testing and QP certification done in NI or an EEA state)
    • Unique identifiers on UK packs exported to GB by an EEA manufacturer or wholesaler will require decommissioning. If these packs will be later supplied to NI, new identifiers should be applied to them and uploaded to the EU medicines verification hub, unless they were placed on the market before 11pm on 31st December 2020.
  • From 1st January 2022 onwards, medicines supplied from GB to NI will require the following importation controls done in NI or an EEA state:
    • Importation via a Manufacture and Importation (MIA) holder
    • Batch testing
    • Certification by a Qualified Person
  • The guidance also advises companies to prepare for supply chain changes to NI routes before 1st January 2022.
  • Finally, the guidance confirms that medicines placed onto the market before the end of the transition period 11.00pm on 31st December 2020 can continue circulating between the two markets (EU and UK).

Here at JensonR+ we can help support you with Brexit related changes, with services ranging from Consultancy Advice to implementing and managing Quality Management Systems. With Regulatory, Quality and Pharmacovigilance teams on hand to offer their knowledge and experience.

Please do not hesitate to get in touch with us.