Tuesday, April 5, 2022

UK and EU agree on phased process for Northern Ireland medicines regulation

The UK government and the European Commission (EC) have reached an agreed approach on a phased process for implementing medicines regulation in Northern Ireland following Brexit (31 December).

The updated agreement was an outcome of the fourth meeting of the Ireland/Northern Ireland Specialised Committee, which was held virtually on 5 November.

The meeting was co-chaired by officials from the UK government and the EC, and a representative from the Northern Ireland Executive also attended as part of the UK delegation.

In a press release issued by the Cabinet Office last Thursday, the UK government said the agreement will provide the additional time needed for businesses to prepare in relation to batch testing, importation and Falsified Medicines Directive requirements.

In addition, the UK and EU agreed on the process for identifying Northern Ireland traders for VAT purpose, allowing them to reclaim VAT through existing IT databases when trading in goods with the EU.

According to the press release, the UK government will set out guidance to businesses on these issues ‘where relevant’.

In response to the Committee outcome, six bodies representing the EU and UK pharmaceutical industry said:

“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,” they added.

The signatories added that under the Northern Ireland Protocol, medicines in Northern Ireland will be governed by EU rules and regulations.

However, they will be enforced by the UK’s medicines regulator – the MHRA. The industry bodies call on the UK and EU to agree on how the regulations will be interpreted and implemented by December 2021.

The signatories also ‘continue’ to urge the UK government and EC to negotiate a mutual recognition agreement for medicines manufacturing.

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