Clinical Trials Act

Clinical Trials (Licence and Fees) Regulations 2011

[GN 168 of 2011 – 24 September 2011 [Section 35]

1. These regulations may be cited as the Clinical Trials (Licence and Fees) Regulations 2011.

2. In these regulations −

"Act" means the Clinical Trials Act;

"licensee" means the holder of a trial licence;

"Phase I", "Phase II", "Phase III" or "Phase IV", in relation to a clinical trial, has the same meaning as in the International Conference Harmonisation document '˜General Considerations for Clinical Trials' (ICH E8), approved by the European Medicines Agency Committee for Proprietary Medicinal Products, now known as the European Medicines Agency Committee for Medicinal Products for Human Use,

This section of the article is only available for our subscribers. Please click here to subscribe to a subscription plan to view this part of the article.