New MHRA Guidance for Wholesalers and Manufacturers

As already reported in the regular weekly ECA Newsletter, the UK Medicines & Healthcare products Regulatory Agency (MHRA) has published a new "Wholesalers & manufacturers guidance following agreement of the Windsor Framework". The rules will take effect on 1 January 2025.

Chapter 4 (Guidance for the Responsible Person for Import (RPi)) and its subchapter (4.1 Wholesale Dealing Activities & RP Functions) outline the requirements for wholesalers, including:

• "A wholesale dealer in Great Britain may only import QP certified medicines from countries on the Approved Country for Import list if certain checks are made by the RPi."
• "Medicinal products sourced from Northern Ireland, including an EU livery inventory, do not require RPi oversight."
• "Wholesalers should ensure that QP certified goods received after midnight on 31 December 2024 intended for UK-wide supply are compliant with the guidance and regulatory requirements."
• "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’."
• "Wholesalers must continue to remain vigilant regarding the licence conditions of products that they procure or supply and segregate these according to destination market, and should establish procedures to safeguard against the supply of non-compliant medicines to Northern Ireland."

For more information, please consult the official MHRA document.