Rules and Guidance for Pharmaceutical Distributors 2017 (The Green Guide) eBook

This new 2017 edition of Rules and Guidance for Pharmaceutical Distributors (the Green Guide), provides you with a single source of guidance to, and legislation for, the distribution of medicines in Europe and 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.

MHRA
1. MHRA: Licensing, Inspection and Enforcement for Medicines Wholesale Distribution of
Medicines
2. EU Legislation on Wholesale Distribution
3. UK Legislation on Wholesale Distribution
4. EU Guidelines on Good Distribution Practice of Medicinal Products for Human Use (2013/C
343/01)
5. UK Guidance on Wholesale Distribution Practice
Brokering of Medicines
6. EU Legislation on Brokering Medicines
7. UK Legislation on Brokering Medicines
8. EU Guidelines on Good Distribution Practice of Medicinal Products for Human Use (2013/C
343/01)
9. UK Guidance on Brokering Medicines
Manufacture, Importation and Distribution of Active Substances
10. EU Legislation on Manufacture, Importation and Distribution of Active Substances
11. UK Legislation on the Manufacture, Importation and Distribution of Active Substances
12. Guidelines of 19 March 2015 on Principles of Good Distribution Practice of Active Substances for Medicinal Products for Human Use (2015/C 95/01)
13. UK Guidance on the Manufacture, Importation and Distribution of Active Substances
Appendices
Appendix 1 – Human and Veterinary Medicines Authorities in Europe
Appendix 2 – List of Persons who can be Supplied with Medicines by Way of Wholesale Dealing (Human Medicines Regulations 2012)
Appendix 3 – Sources of Useful Information
Appendix 4 – Licensing for Import into the UK and Export from the UK Including Introduced Medicine – Wholesale Supply Only
Appendix 5 – Importation of Active Substances for Medicinal Products for Human Use – Questions and Answers
Appendix 6 – Safety Features for Medicinal Products for Human Use – Questions and Answers
Index