🇬🇧 Post-Brexit UK Regulatory Framework

The UK continues to refine its own regulatory pathways for manufacturers and wholesalers. This includes unique UK-only authorisations, labelling rules, and independent inspection schedules.

What This Means for You:

• Expect divergence between EU and UK procedures.
• Ensure dual QP oversight and clear documentation for EU vs UK batch release.

Update SOPs and technical agreements accordingly.

Key points

Here are some key points:

Labeling: Medicines must display a ‘UK Only’ label, starting January 1, 2025.
Wholesalers should ensure that, when importing goods under the RPi process, the goods that are QP certified after midnight on 31 December 2024 are compliant with the conditions of MHRA guidance and feature ‘UK Only’.

FMD Disapplication: The EU Falsified Medicines Directive will no longer apply, FMD-compliant barcodes must be fully removed or covered.