Books by Medicines and Healthcare products Regulatory Agency

The 2022 edition of the Rules and Guidance for Pharmaceutical Distributors, the 'Green Guide', is the essential reference for all distributors, brokers of human medicines, importers and distributors of active substances in the UK.It provides you with the single authoritative source of European good distribution practices and UK guidance, information and UK legislation on these activities.The new 5th edition has been updated to incorporate changes made after the UK's exit from the European Union on the 31st January 2020.It also incorporates new guidance on pharmacovigilance for wholesalers, the naming of sites on a licence, self-inspection, and the responsible person for import.It brings together EU guidance on good distribution practice and the MHRA's expectations for compliance. There is also a new flowchart for the registration of handling active substances

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. This text provides practical advice about achieving an appropriate system of pharmacovigilance.