A number of legislative changes have been made to strengthen and clarify the legal obligations of marketing authorisation holders. There is now an EU Directive governing the conduct of clinical trials which came into force in the United Kingdom on 1 May 2004. This introduced a criminal offence for the failure to report adverse reactions occurring in clinical trials.
Changes were also introduced to European Union medicines legislation from October 2005 which clarify the obligation to report relevant safety information arising from clinical trials using products outside their normal conditions of use. These were implemented in the UK from 30 October 2005 and include an obligation to provide specified information promptly.
UK legislation was amended in December 2008 to specify prompt reporting requirements for clinical trials, including those conducted outside the European economic area and outside the terms of any marketing authorisation valid in the UK.
European legislative proposals published in December 2008 further clarify the legal obligations on marketing authorisation holders to report harmful effects and to do so promptly.