Medicines and Healthcare Products Regulatory Agency Books

The 2022 edition of Rules and Guidance for Pharmaceutical Manufacturers and Distributors, known as "The Orange Guide", is the essential reference for all manufacturers and distributors of medicines in the UK.

Pharmacovigilance is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products, herbalism and traditional medicines with a view to identifying hazards and preventing harm to patients.