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MHRA and EU: Medicinal products in Northern Ireland
12.03.2021

MHRA and EU: Medicinal products in Northern Ireland

The European Commission published a Notice this January dealing with the legal framework for medicinal products marketed in Northern Ireland. On 9 March 2021, the UK MHRA, for its part, followed up and also addressed the issue. 

The MHRA provides two scenarios in its "guidance" that mirror the EU provisions, for:  

  • products approved in the U.K. before Jan. 31, 2021.  

  • products approved in the U.K. after Jan. 31, 2021, but before Dec. 31, 2021.  

In principle, the objective is to ensure continuity of supply to Northern Ireland by allowing the flexible batch release options of a QP to apply both at an EU site or at any UK site if equivalent levels of EU standards can be demonstrated and regulatory oversight is in place. If a pharmaceutical manufacturer in Northern Ireland makes use of this "flexibility option," the MHRA does not need to be notified separately. If this option is not used, the MHRA expects to be informed with given reasons.  

The EU expects a corresponding batch test to be established in Northern Ireland or the EU by December 31, 2021, at the latest. The scheme will also apply to new products approved in the UK before December 31, 2021. This is intended to give Northern Ireland sufficient time to respond to the changes resulting from Brexit.


Source
MHRA: Brexit Guidance



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