UK MHRA Guidance for QPs and RPis Following the ‘Windsor Framework’

Date

September 26, 2024

Category

UK Regulations

Description

On 12 September 2024 the MHRA issued new guidance titled “Wholesalers & manufacturers guidance following agreement of the Windsor Framework”. This contains guidance specifically for Qualified Persons (QPs), Responsible Persons (RPs) and Responsible Persons for Import (RPis) in order to implement the arrangements of the Windsor Framework for human medicines.

The guidance for QPs has the following sections:

• Labeling and packaging requirements
  • Application of ‘UK Only’ label
  • Stickering with “UK Only” label
  • Early release to market
  • Medical devices
• Falsified Medicines Directive
  • EU based QPs
  • UK based QPs
• Northern Ireland MHRA Approved Route (NIMAR)
• Export activity
• Activities performed in Northern Ireland
• EEA Storage facilities
• Location of QP

The guidance for RPis covers wholesale dealing activities & RP functions.

This guidance can be found at https://www.gov.uk/government/publications/wholesalers-manufacturers-guidance-following-agreement-of-the-windsor-framework/wholesalers-manufacturers-guidance-following-agreement-of-the-windsor-framework

NOTE: The Windsor Framework only applies to human medicines. However, in December 2022 the European Commission announced that the transitional arrangements for veterinary products, which have been in place since the UK left the EU, had been extended to December 2025.