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Updated Statement on supply of medicines to Northern Ireland

Mark Samuels, Chief Executive of the British Generic Manufacturers Association (BGMA), said: “With more information about the European Union's legislative proposal on the treatment of medicines supplied to Northern Ireland now available, our members and we are increasingly positive that it provides the basis for a durable solution for which we have long called for. We are pleased that our industry's concerns, which we have highlighted for over a year, have been heard, prioritised, and acted on.

"We expect MHRA guidance, alongside EU draft legislation, in due course. We will need to study these details, but based on the information released to date, we support many of the proposals, including:

  • The ability of the MHRA to issue and maintain UK-wide product licences.
  • Regulatory importation requirements to be permanently removed for all medicines moving between GB and NI.
  • Regulated activities, like batch testing and Qualified Person approval, will be conducted in GB for medicines supplied to NI.
  • The same packaging will be accepted for GB and NI-bound products.
  • An extension of three years whereby product made in the EU and supplied to NI through GB doesn't need to have its safety features decommissioned on GB arrival, only to be required to be uploaded again for sale in NI.
  • The existing regulatory derogations in supplying NI from GB will continue for the whole of 2022 to allow a smooth transition to these new rules.

"There remains essential work to do. For example, it will be necessary for GB or NI Marketing Authorisation licences granted in 2021 (as well as for those under assessment or recently split into GB and NI) to be converted to cover the whole of the UK.

"Also, now that the EU has published this proposal and extended the period that regulatory flexibilities apply, we ask all European member state regulators to allow regulatory activity in Great Britain to be used for medicine licences for Northern Ireland.

"Finally, we would like to pay tribute to the EU and the UK Government for their joint-working in developing this proposal and for prioritising the issue of medicines supply to Northern Ireland. We believe that this is the right approach for the people of the region, and we look forward to working with all parties in 2022 to deliver smooth implementation."