Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2022 (The Orange Guide)

Rules and Guidance for Pharmaceutical Manufacturers and Distributors (The Orange Guide, 2022 Edition)
The 11th edition of the Orange Guide is the essential reference for medicine manufacturers and distributors in the UK. It combines European and UK guidance, legislation, and regulatory requirements on the manufacture, distribution, and importation of human medicines and active substances. Updated after Brexit, it includes amendments to the Human Medicines Regulations 2012, new guidance on manufacturing authorisations, investigational medicinal products, pharmacovigilance, and revised GMP annexes. Compiled by the MHRA, it remains the authoritative source for compliance and good practice in the pharmaceutical industry.