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
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