Rules and Guidance for Pharmaceutical Manufacturers and Distributors (Orange Guide) 2022

Compiled by the Inspection, Enforcement and Standards Division, Medicines and Healthcare products Regulatory Agency (MHRA), London, UK

The 2022 edition of Rules and Guidance for Pharmaceutical Manufacturers and Distributors, known as "The MHRA Orange Guide”, is the essential reference for all manufacturers and distributors of medicines in the UK.

It provides you with a single authoritative source of European and UK guidance, information and UK legislation relating to the manufacture and distribution of human medicines, active substances, and brokering medicines.

The new 11th edition 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:

·   manufacture, importation and assembly

·   wholesale dealing

·   brokering medicine

·   manufacturing, importing and distributing active substances

·   The Code of Practice for Qualified Persons, 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 or active substances

·   UK guidance on: risk-based inspections, conditions of holding a manufacturer’s licence, wholesale dealer’s licence, a broker registration and an active substance registration, and controls on certain medicinal products.

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.

The MHRA Orange Guide is compiled by the Medicines and Healthcare products Regulatory Agency.