MHRA: Guidance for Manufacturers Following Revised Brexit Deal
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued new guidance for wholesalers and manufacturers in response to the Windsor Framework, which updated the terms of Brexit.
The Windsor Framework establishes long-term provisions for the supply of medicines to Northern Ireland, shifting some regulatory powers. MHRA will now regain the authority to license medicines across the UK, and the EU Falsified Medicines Directive safety features will no longer apply to products in Northern Ireland. These changes will take effect at the beginning of next year.
In preparation for this transition, MHRA has released guidance targeted at Qualified Persons (QPs) and Responsible Persons for Import (RPis). The guidance for QPs outlines the new requirements for labeling medicines as "UK Only", which will be mandatory for products entering the UK market starting next year.
According to MHRA, “‘UK Only’ may be presented anywhere on the outer packaging of the medicine so long as it is in a conspicuous place in such a way that it is clearly visible.”
In addition, the document provides guidance for wholesalers importing QP-certified products through the RPI process from 1 January 2025 onwards. They should ensure that the products comply with the terms of the MHRA guidance and carry a 'UK Only' label.
Source:
MHRA: Medicines, medical devices – Wholesalers & manufacturers guidamce folowing agreement of the Windsor Framework
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