1 Medicines for Human Use (Clinical
Trials) Regulations 2004: defective drafting
Medicines for Human Use (Clinical Trials) Regulations
2004 (S.I. 2004/1031)
1.1 The Committee draws the special attention
of both Houses to these Regulations on the ground that they are
defectively drafted.
1.2 In a memorandum printed at the Appendix, the
Department of Health acknowledges that the references in the various
provisions mentioned in the Committee's question should have been
as indicated by the Committee. It also accepts that paragraph
1(1) of Schedule 4 should have been expressed to apply to the
case where the Authority receives a notice pursuant to regulation
16(4)(b), and undertakes to correct the errors at the earliest
opportunity. The Committee accordingly reports the provisions
in question for defective drafting, acknowledged by the Department.