Clinical Trials Directive 2001/20/EC

Richmond Pharmacology briefing document

This briefing document summarises the key potential implications of the Clinical Trials Directive 2001/20/EC for Richmond Pharmacology and how this affects sponsor companies. Please use the links below to read the briefing.

• Introduction
• 1. Obtaining authorisation to conduct a clinical trial
• 2. Good manufacturing practices (GMP): Manufacture of investigational medicinal products (IMPs)
• 3. Non-NHS Research Ethics Committees (RECs)
• Appendix 1: Information required for UK applications to the MHRA

For further information contact the MHRA Clinical Trials Unit at:

12-2 MHRA
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Telephone: 020 7084 2327
Fax: 020 7084 2443
Email: clintrialhelpline@mhra.gsi.gov.uk
Website: http://www.mca.gov.uk

Printable version

If you would like a printed copy of this briefing document, it may be more convenient to use our printable version than to print out these web pages:

• Clinical Trials Directive 2001/20/EC: Richmond Pharmacology briefing document (PDF, 132 kb)

This file is in PDF format and you will need Adobe Acrobat Reader or another PDF reader to view or print it.

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