MHRA issues final call to comply with Windsor Framework arrangements for medicines from January 2025
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a final call to businesses to comply with the new arrangements for the regulation of medicines in Northern Ireland under the Windsor Framework.
The Windsor Framework, agreed by the UK and EU in October 2022, sets out a new protocol for Northern Ireland which aims to protect the Good Friday Agreement and ensure the smooth flow of goods between Northern Ireland and the rest of the UK.
Under the new arrangements, medicines will continue to be regulated by the MHRA in Northern Ireland, but some EU rules will apply in order to protect the EU’s single market.
Businesses that place medicines on the market in Northern Ireland will need to comply with these new rules from 1 January 2025.
The MHRA has published guidance on the new arrangements, which can be found on the MHRA website.
The MHRA is urging businesses to take action now to ensure that they are compliant with the new arrangements.
MHRA Chief Executive Dr June Raine said:
“The Windsor Framework provides a new way forward for the regulation of medicines in Northern Ireland.
“It is essential that businesses take action now to ensure that they are compliant with the new arrangements.
“The MHRA is here to support businesses with this process and we urge them to contact us if they have any questions.”
The MHRA has also published a number of Frequently Asked Questions (FAQs) on the new arrangements, which can be found on the MHRA website.
Key points for businesses:
- From 1 January 2025, businesses that place medicines on the market in Northern Ireland will need to comply with the new arrangements set out in the Windsor Framework.
- The MHRA has published guidance on the new arrangements, which can be found on the MHRA website.
- The MHRA is urging businesses to take action now to ensure that they are compliant with the new arrangements.
Further information:
- The Windsor Framework can be found on the GOV.UK website.
- The MHRA guidance on the new arrangements can be found on the MHRA website.
- The MHRA FAQs on the new arrangements can be found on the MHRA website.
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