13/14 December 2023
In the course of the Brexit negotiations, the role of Northern Ireland was always in focus. The aim of the EU in particular was to avoid a hard border on the island of Ireland.
The result was the so-called Protocol on Ireland and Northern Ireland, which "avoids a hard border between Ireland and Northern Ireland, thereby enabling the smooth functioning of the all-island economy and safeguarding the Good Friday (Belfast) Agreement in all its dimensions, ensures the integrity of the EU's Single Market for goods, along with all the guarantees it offers in terms of consumer protection, public and animal health protection, and combatting fraud and trafficking".
But it is complicated and there have been a number of follow-up documents.
End of January, the EU Commission published a new notice entitled "Application of the Union's pharmaceutical acquis in markets historically dependent on medicines supply from or through Great Britain after the end of the transition period" (2021/C 27/08). In this document, a good summary is given on the situation:
The EMA has now updated its question and answer document on the implementation protocol. Of particular interest is question and answer 14.3 ("How will the manufacturing and import authorisations, GMP certificates and GMP non-compliance statements for sites in Northern Ireland be issued and made available and will the same apply GMP certificates issued by the UK authorities for sites in other locations?) Here it was added or clarified that according to the provisions of the previous agreement between the EU and the UK, both sides recognise the results of GMP inspections of the other party. National documents from the UK authority such as GMP certificates and inspection reports for locations in the UK will continue to be accepted in the EU as confirmation of GMP compliance in connection with regulatory submission and/or import applications. The same applies to inspections in third countries. The GMP certificates issued here can at least serve as supporting information in regulatory submissions.