Rules and Guidance for Pharmaceutical Distributors 2022 (The Green Guide)

Rules and Guidance for Pharmaceutical Distributors (The Green Guide, 2022 Edition)
The 5th edition of the Green Guide is the essential reference for distributors, brokers of human medicines, and importers or distributors of active substances in the UK. It combines European Good Distribution Practice (GDP) with UK legislation and MHRA guidance, providing a single authoritative source for compliance.

Updated after the UK’s exit from the EU, this edition includes amendments to the Human Medicines Regulations 2012, new guidance on pharmacovigilance for wholesalers, licensing requirements, self-inspection, and the role of the responsible person for import. It also features a new flowchart for active substance registration.

Compiled by the Medicines and Healthcare products Regulatory Agency and published by Pharmaceutical Press, the Green Guide remains the definitive resource for ensuring high standards in medicine distribution and regulatory compliance.