Ensuring Medicine Access: The Windsor Framework’s UK-Centric Solution

Background

In view of the United Kingdom’s exit from the European Union, being well aware of the latest requirements is necessary for businesses to prosper. The Windsor Framework is one such framework that is going to be introduced on 1 January 2025.

Key points of Windsor Framework include the following:

• Long-term plans related to a supply of medications to Northern Ireland have been outlined.
• Medicines are allowed to be used in the same packaging and with the same labelling across the United Kingdom.
• New regulations have been made to solve the problems experienced in compliance with the Northern Ireland Protocol (NIP), especially for goods entering Northern Ireland from the United Kingdom.

Labelling Requirements

Implementation Plan

For implementing new artworks, marketing authorisation holders (MAHs) must notify the Medicines and Healthcare products Regulatory Agency (MHRA) by 31 December 2024 via self-certification or any upcoming regulatory submission.

How can APCER support your company with the new MHRA requirements?

For any support regarding compliance to the new MHRA requirements, please contact APCER’s team of regulatory professionals who can support MAHs in devising strategies, evaluation, authoring and submissions of the post-approval life cycle applications/variations to the UK MHRA and European Medicines Agency (EMA).
With a team of seasoned experts well versed in the nuances of regulatory frameworks, APCER meticulously crafts document that withstand the scrutiny of governing bodies. APCER’s comprehensive regulatory writing services provide a tailored solution to ensure that your business remains compliant and adapts seamlessly to new requirements.