MHRA Green Guide Update 2022

by | May 10, 2022 | Blog, MHRA

There is a new MHRA Green Guide Update 2022 updated edition of the Rules and Guidance for Pharmaceutical Distributors called the MHRA Green Guide. The guide is an essential reference for all brokers of human medicines, importers, and distributors of active substances in the UK.

The MHRA Green Guide is compiled by the Medicines and Healthcare products Regulatory Agency and is the single authoritative source of European good distribution practices and UK guidance, information, and UK legislation on these activities. This new 5th edition has been updated to incorporate changes made since the UK’s exit from the EU on the 31st of January 2020.

Comprehensive new content

The updated guide also incorporates:

  • New guidance on pharmacovigilance for wholesalers, self-inspection, the naming of sites on a license, and the responsible person for import.
  • Amended extracts from the Human Medicines Regulations 2012 relating to wholesale dealing, brokering medicine, importing and distributing active substances
  • UK guidance on complying with the EU guidelines on Good Distribution Practice for wholesale distributors and brokers of medicines and importers and distributors of active substances
  • UK guidance on risk-based inspections, conditions of holding a wholesale dealer’s license, a broker registration, and an active substance registration, a responsible person for import and controls on certain medicinal products.
  • There is also a new flowchart for the registration of handling active substances, and it brings together in one chapter EU guidance on good distribution practice and the MHRA’s expectations for compliance.

Good Distribution Practice (GDP) update training in line with the new MHRA Green Guide 2022

Join us for our new GDP update training which provides an overview of the changes as defined in the MHRA Green Guide 2022, hot off the press.

Who is the course for?

If you are a wholesaler of medicines or hold a WDA, MS, or MIA, or if you work for an organisation that holds one of these authorisations then this course is for you. This course provides an update that is aimed at everyone within your organisation and can be delivered either face to face or online.

This course will benefit:

  • Licence Holders
  • Quality managers
  • Personnel in regulatory compliance
  • Distribution & Warehouse staff
  • Supply chain management and Logistic partners
  • Customer service
  • Pharmacy team members who want to wholesale medicines
  • Finance

To book a place for our GDP/RP Green Guide 2022 Update course please visit our booking page


Jackie is very knowledgeable, I have learnt so much from her in so little time. Thank you Jackie for being a fountain of knowledge!
Mahmuda Kahatun superintended pharmacist