Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2022 (The MHRA Orange Guide)
MHRA (Medicines and Healthcare products Regulatory Agency)
Compiled by the Inspection, Enforcement and Standards Division, Medicines and Healthcare products Regulatory Agency (MHRA), London, UK
- 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.
- 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.

- ISBN 978 0 85711 439 6
- Published Mar 2022
- Paperback
244x172mm (1140pp)