NLClinicalTrialsIMP object

Applicable national regulations

National Act on Medicinal Products

Transposition of (CT) Directive 2001/20/EC (or comparable national legal framework)

On 1 May 2004 the first Clinical Trials regulation came into force, followed by several amendments, implementing the Clinical Trials Directive 2001/20/EC and GCP Directive 2005/28/EC.
- The Medicines for Human Use (Clinical Trials) Regulations 2004
- The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006
- The Medicines for Human Use (Clinical Trials) Amendment (No.2) Regulations 2006

Transposition of (GCP) Directive 2005/28/EC

Incorporated in transposition act(s) of Directive 2001/20/EC

Additional Information

Please note that in addition to the main amendments listed above, there have been several additional amendments to the original Statutory Instrument and the legislation is constantly evolving. For up to date comprehensive list of all relevant amendments please see MHRA.

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395
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