The MHRA Orange Guide

The new edition of the MHRA Orange Guide has been updated to incorporate new European and UK guidance, information and UK legislation relating to the manufacture and distribution of human medicines, active substances, and brokering medicines.

Now in its 11th edition, the Orange Guide has been updated to incorporate changes made after the UK’s exit from the European Union on the 31st January 2020.

Comprehensive new content includes:

• amended extracts from the Human Medicines Regulations 2012 relating to:
  o manufacture, importation and assembly,
  o wholesale dealing,
  o brokering medicine and
  o manufacturing, importing and distributing active substances.
• The Code of Practice for Qualified Persons in chapter three, Guidance on Manufacture and Importation.
• UK guidance on complying with the EU guidelines on Good Distribution Practice for wholesale distributors and brokers of medicines and manufacturers, importers and distributors of active substances.
• UK guidance on:
  o risk-based inspections,
  o conditions of holding a manufacturer’s licence, wholesale dealer’s licence, a broker registration and an active substance registration, and
  o controls on certain medicinal products.

There is also new guidance on:

• Conditions of holding a manufacturing authorisation for investigational medicinal products,
• Importing guidance for investigational medicinal products from countries on a list to Great Britain,
• Pharmaceutical Quality System expectations and Authorisation requirements for investigational medicinal products importation oversight,
• List of approved countries for import,
• Pharmacovigilance for wholesalers,
• The naming of sites on a wholesale dealer’s licence,
• Self-inspection for wholesale dealers and the responsible person for import.

Plus, revised GMP Annexes 2 and 17, and Commission guidance on principles and guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections, for medicinal products for human use and for active substances for medicinal products for human use.

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.