MHRA: New Rules for Manufacturers and Wholesalers after Brexit

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has published new guidance for pharmaceutical manufacturers and wholesalers in order to implement the arrangements of the Windsor Framework for human medicines. The rules will apply from 1 January 2025. 
It covers labeling, packaging, and importing requirements for human medicines, including the use of 'UK Only' labels and the disapplication of the EU Falsified Medicines Directive (FMD). Specific instructions are given for Qualified Persons (QPs) and Responsible Persons for Import (RPis).

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.

Activities performed in Northern Ireland:
MHRA remains the National Competent Authority in Northern Ireland. All new medicines and medicines in Northern Ireland that currently fall under the scope of the EU Centralised Authorisation Procedure will be authorised by the MHRA for the UK market. Joint packs between the UK and EU will no longer be possible.
Northern Ireland based QPs who are named on a Northern Ireland GMP authorisation may continue to perform batch certification for both UK and EU markets.

EU/EEA Storage facilities:
It will no longer be possible to utilise EEA located storage facilities to store 'UK Only' labelled medicines. That means it will no longer be possible to send goods into the EEA from the UK for storage purposes.

Location of QP:
QPs named on a MHRA Manufacturing and Import Authorisation (MIA) must be resident in the UK.

For more details, see MHRA website.