The MHRA Orange Guide
The MHRA Orange Guide
The reference source for manufacturers and distributors of medicines
From Medicines and Healthcare Regulatory Agency (MHRA). Based on current regulation, and regularly updated to reflect changes in best practices, legal requirements, and emerging technologies.
Rules and Guidance for Pharmaceutical Manufacturers and Distributors (The MHRA Orange Guide) is compiled by the Medicines and Healthcare Regulatory Agency (MHRA) as the single source of European and UK guidance and UK legislation on the manufacture and distribution of human medicines, active substances, and brokering medicines.
- 16,000+
- Page views
- 190+
- Users per month
- 600+
- Searches
Supports medicines manufacturers and distributors in meeting legal requirements
The Code of Practice for Qualified Persons
Conditions and guidance for investigational medicinal products
Incorporates changes made after the UK’s exit from the European Union
Minimises research time
Aids good practice
GMP and GDP guidance for active substances
Naming of sites on a licence
Provides a framework for continuous improvement in quality control and monitoring
Request access today
Access The MHRA Orange Guide through MedicinesComplete today.
Contact us now for pricing and access information.
Related resources
Related knowledge products
Related publications
-
NEWBNF for Children (BNFC) 2025-2026
The first choice for concise medicines information for children.
Info -
BEST SELLERRules and Guidance for Pharmaceutical Manufacturers and Distributors (The MHRA Orange Guide) 2022
The reference for manufacturers and distributors of medicines in Europe and the UK
Info -
Dale and Appelbe’s Pharmacy and Medicines Law Thirteenth Edition
Essential guide to pharmacy and medicines law in Great Britain
Info
See all our printed publications in the Shop.
Access the essential knowledge you need today
Opens in a new window