HL Deb 30 June 2003 vol 650 cc70-1WA
Baroness Hayman

asked Her Majesty's Government:

What are their current plans and timescale for implementing the European Union Directive on Good Clinical Practice. [HL3558]

Lord Warner

The European Union Directive on Good Clinical Practice (Directive 2001/20/EC) contains within it an implementation date of 1 May 2004. The draft United Kingdom legislation to transpose this directive, the Medicines for Human Use (Clinical Trials) Regulations 2003, has been out for a period of public consultation. The responses to this consultation are being evaluated. The Medicines and Healthcare Products Regulatory Agency and the Department of Health will continue to work with the various groups who have raised issues to address their concerns before finalising plans and time-scales for implementation within the UK.