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Rules and Guidance for Pharmaceutical Distributions (The MHRA Green Guide) 2022

Rules and Guidance for Pharmaceutical Distributions (The MHRA Green Guide) 2022

Edited by MHRA



The reference for medicine distributors in Europe and the UK

Published1st Mar, 2022
Page count400


It is the single authoritative source of European good distribution practices and UK guidance, information and UK legislation on these activities. The new edition has been updated to incorporate the changes made after the UK's exit from the European Union.

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


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