Rules and Guidance for Pharmaceutical Distributors (Green Guide) 2022

The 2022 edition of the Rules and Guidance for Pharmaceutical Distributors, the "MHRA Green Guide”, is the essential reference for all distributors, brokers of human medicines, importers and distributors of active substances in the UK.

It provides you with the single authoritative source of European good distribution practices and UK guidance, information and UK legislation on these activities.

The new 5th edition has been updated to incorporate changes made after the UK’s exit from the European Union on the 31st January 2020.

It also incorporates new guidance on pharmacovigilance for wholesalers, the naming of sites on a licence, self-inspection, and the responsible person for import.

It brings together EU guidance on good distribution practice and the MHRA’s expectations for compliance. There is also a new flowchart for the registration of handling active substances.

Comprehensive new content includes:

·   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 licence, a broker registration, and an active substance registration, a responsible person for import and controls on certain medicinal products.

The MHRA Green Guide is compiled by the Medicines and Healthcare products Regulatory Agency.

Published by Pharmaceutical Press, the publishing arm of the Royal Pharmaceutical Society.