Rules and Guidance for Pharmaceutical Distributors 2017 (The Green Guide)
The Green Guide
MHRA (Medicines and Healthcare products Regulatory Agency)
Compiled by the Inspection, Enforcement and Standards Division, MHRA, London, UK.
The Green Guide reproduces all the elements of the new Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2017 (the Orange Guide) that are relevant to distributors. So if you’re involved in the wholesale supply, distribution and brokering of medicines for human use and the distribution of active substances, this is the one-stop guide you need.
This tenth edition has been updated to incorporate the revised EU Guidelines on Good Distribution Practice.
In addition, it includes new sections on:
• the guidelines on principles of Good Distribution Practice of active substances for medicinal products for human use (2015/C 95/01)
• matters relating to unlicensed medicines
• sourcing and exporting medicinal products – non-EEA countries
• data integrity
• the EU regulation on safety features for medicines
It includes revised sections on:
• qualification of suppliers and customers
• controls on certain medicinal products
• parallel importation and parallel distribution
• the application and inspection process for new licences: "what to expect”
• updated UK legislation
• temperature control and monitoring.
The Green Guide is essential reading for anyone subject to MHRA inspection, providing you with all the answers you need to stay informed.
It is compiled by the Inspection, Enforcement and Standards Division, MHRA, London, UK [www.gov.uk/mhra].
The Green Guide is also available online via MedicinesComplete.
- ISBN 978 0 85711 286 6
- Published Jan 2017
244 x 172mm
Other formats available
Online via MedicinesComplete
Rules and Guidance for Pharmaceutical Distributors (the Green Guide) is available...
Essential guidance for distributors of medicines for human use in Europe,...