The Green Guide

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.

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.