The MHRA Orange Guide
The reference source for manufacturers and distributors of medicines
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 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.
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 knowledge products
Related publications
-
FEATUREDNon-prescription Medicines Fifth Edition
The only book in the UK that looks at available over-the-counter (OTC) medicines comprehensively.
Info -
BEST SELLERBritish National Formulary (BNF85)
The first choice for concise medicines information Practical and evidence based, British National…
Info -
FEATUREDDale and Appelbe’s Pharmacy and Medicines Law Twelfth Edition
Guide to law and ethics for pharmacy practice in Great Britain
Info
See all our printed publications in the Shop.
Access the essential knowledge you need today
Opens in a new window
Environment: dev