Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2022 (The Orange Guide)
- Free UK Shipping on All Orders
- In stock, ready to ship
The Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2022 (11th Edition) – The Orange Guide
A comprehensive reference from the MHRA for the manufacture, importation, distribution, and brokering of human medicines and active substances in the UK and Europe.
-
Amended in line with the Human Medicines Regulations 2012 covering manufacturing, importation, assembly, wholesale dealing, and brokering.
-
Includes the Code of Practice for Qualified Persons and guidance on manufacture and importation.
-
UK guidance on Good Distribution Practice (GDP) for distributors, brokers, manufacturers, importers, and active substance suppliers.
-
Covers inspections, licensing conditions, broker registration, and controls on specific medicinal products.
-
Updates on investigational medicinal products, manufacturing authorisations, importation requirements, and pharmaceutical quality systems.
-
Revised GMP Annexes 2 and 17 and Commission guidance on good manufacturing practices for investigational medicinal products and active substances.
Essential for professionals in the pharmaceutical industry seeking regulatory and practical guidance in the UK.
📦 Shipping Speed:
UK Delivery: 2–4 business days
All orders are processed within 1–3 business days, and you’ll receive a tracking link once your order has been dispatched.