Rules and Guidance for Pharmaceutical Distributors (commonly known as the Green Guide) provides you with a useful, single source of guidance and legislation on the distribution of medicines

The 2022 edition of the Rules and Guidance for Pharmaceutical Distributors, the Green Guide is now available through MedicinesComplete.  

The updates incorporate changes made after the UK’s exit from the European Union on the 31 January 2020. Providing new guidance on pharmacovigilance for wholesalers, the naming of sites on a licence, self-inspection, and the responsible person for import.

The content is taken from the distributors’ section of the Orange Guide. Compiled by the Inspection, Enforcement and Standards Division, Medicines and Healthcare products Regulatory Agency (MHRA), London, UK.

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Publication Updates

14 Jun
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The Green Guide June 2022 Update

The 2022 edition of the Rules and Guidance for Pharmaceutical Distributors 2022 (The Green Guide) is now available through MedicinesComplete. 

This new edition of the MHRA Green Guide has been updated to incorporate new guidance on pharmacovigilance for wholesalers, the naming of sites on a licence, self-inspection, and the responsible person for import.

It brings together in one chapter 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:
    o wholesale dealing,
    o brokering medicine and
    o 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
    o risk-based inspections,
    o conditions of holding a wholesale dealer’s licence, a broker registration, and an active substance registration,
    o a responsible person for import and
    o controls on certain medicinal products.
11 Dec
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Green Guide December 2018 update

Updates have been made to the following section of the Rules and Guidance for Pharmaceutical Distributors:

Chapter 5 – UK Guidance on Wholesale Distribution Practice

Subsection – ‘Short-term Storage of Ambient and Refrigerated Medicinal Products – Requirements for a Wholesale Dealer’s Licence’

10 Jul
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Green Guide July 2018 update

July 2018: Rules and Guidance for Pharmaceutical Distributors now updated

Update has been made to UK Guidance on Wholesale Distribution Practice – Appointment and Duties of the Responsible Person as well as The Responsible Person Gold Standard.

The section has been updated to incorporate sub-headings and text: Responsible Person, Eligibility requirements, Responsibilities of an RP, Obligations of the Licence Holder, Contract RPs, Small companies, Knowledge requirements, Experience requirements, Assessment of RP knowledge and experience, Reporting arrangements, Deputy RP and delegation of RP activities, Dispute resolution.