Trade bodies welcome regulatory steps for medicines in Northern Ireland

Pharmaceutical representatives have welcomed steps taken by the UK and EU on the implementation of medicine regulations in Northern Ireland.

At the fourth meeting of the Ireland/Northern Ireland Specialised Committee, the UK and EU agreed to a phased process for implementing medicines regulation in Northern Ireland up until 31 December 2021.

The agreement was made to give businesses additional time to prepare for processes including batch testing, importation and the requirements set out by the Falsified Medicines Directive (FMD).

The joint decision was made in regard to the Northern Ireland Protocol, under which medicine in Northern Ireland will be governed by EU rules and regulations. These rules however will be enforced by the Medicines and Healthcare products Regulatory Agency (MHRA), the UK’s medicines regulator. The UK and EU now need to agree on how the regulations will be implemented following December 2021.

Representatives from The Association of the British Pharmaceutical Industry (ABPI); the European Federation of Pharmaceutical Industries and Associations (EFPIA); the Association of the European Self-Medication Industry (AESGP); Medicines for Europe; the British Generic Manufacturers Association (BGMA); and PAGB, the consumer healthcare association, welcomed the news.

“This is good news for patients in Northern Ireland. We are pleased the UK Government and EU Commission have responded to the concerns raised by industry and removed the immediate threat of a cliff-edge in the way medicines are distributed to Northern Ireland from the end of this year.

“We await the detail of how this will work in practice and there is much work to do. But this is a pragmatic step in the right direction. Both sides must now use the next eight weeks to clarify the rules which will apply in Northern Ireland from 2022, so that companies can make full use of this extra time to prepare for the long-term,” a joint statement said.