EU accepts MHRA inspections

Recommendation

13/14 December 2023
Berlin, Germany

Root Cause Analysis
A CAPA Workshop on Successful Failure Investigation

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:

• Medicinal products (in the scope of the abovementioned legislation) placed on the market in Northern Ireland must comply with the regulatory requirements laid down in Union law;
• Medicinal products must have a valid marketing authorisation in the EU or in Northern Ireland;
• Trade in medicinal products from Great Britain to Northern Ireland or to the Union constitutes an import in the sense of applicable Union law;
• Trade in medicinal products from the Union or Northern Ireland to any other part of the United Kingdom (Great Britain) or any other third country constitutes an export in the sense of applicable Union law;
• Authorisations issued by UK authorities are, in principle, not valid under Union law, but can only be recognised in Northern Ireland if adopted in accordance with applicable Union law;
• Any steps in the supply of medicines which must be carried out in the Union (e.g. batch release) in order to allow for the placing on the market of medicinal products in accordance with Union law must occur in the (geographical) scope of Union law, i.e. in the Union or Northern Ireland, and only actions that may be carried out in third countries may occur in Great Britain.

EU accepts MHRA Inspections

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.