Rules and Guidance for Pharmaceutical Distributors
Medicines and Healthcare products Regulatory Agency
Compiled by the Medicines and Healthcare products Regulatory Agency (MHRA), this publication provides guidance for distributors of medicines for human use in Europe.
First published in 2007, Rules and Guidance for Pharmaceutical Distributors reproduces those elements of the 2007 edition of Rules and Guidance for Pharmaceutical Manufacturers and Distributors (commonly known as the "Orange Guide") specific to the wholesale supply and distribution of medicines for human use.
This is essential information to ensure the safe distribution of medicines and the safety of the public.
The information contained in this guide is also available online in Rules and Guidance for Pharmaceutical Manufacturers and Distributors via MedicinesComplete.
The new print edition of Rules and Guidance for Pharmaceutical Distributors will be published in Autumn 2013.
Section 1: Medicines and Healthcare products Regulatory Authority (MHRA)
1. MHRA: Licensing, inspection and enforcement for human medicines
Overview of MHRA
Defective Medicines Report Centre (DMRC)
Enforcement and intelligence group
Section 2: Guidance on Wholesale Distribution Practice
2. EU guidance on wholesale distribution practice
Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C 63/03)
3. UK guidance on wholesale distribution practice
Wholesale dealer's obligations
Appointment and duties of the responsible person
Control and monitoring of storage and transportation temperatures
Counterfeits/Ensuring bona fides
Section 3: Legislation on Wholesale Distribution
4. EU legislation on wholesale distribution
Directive 2001/83/EC, as Amended, Title VII, Wholesale distribution
5. UK legislation on wholesale distribution
The Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005 (SI 2005 No. 2789)
Section 4: Glossary of Legislation
6. Glossary of legislation
Primary (UK) legislation
Secondary legislation (UK statutory instruments)
Section 5: Index
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ISBN 978 0 85369 758 9
Published Jun 2007
244 x 172mm (96pp)
Other formats available
Online via MedicinesComplete
Now available online via MedicinesComplete, the Orange Guide is an essential...