Further memorandum by
the Department of Health
1999 (S.I. 1999/3106)
1. In the light of the Committee's
concerns about the Department's response, in a memorandum dated
2nd December 1999, to the first point raised by the Committee
in respect of the Good Laboratory Practice Regulations 1999 ("the
regulations"), the Department has prepared this further memorandum.
2. As indicated in the earlier
memorandum, the Department agrees that the words suggested by
the Committee could have been included in the definition for "regulatory
study". The Department also recognises that the suggestion
of the Committee is a clear improvement on the wording of the
definition in the current version of the Regulations, and will,
when the Regulations are next amended or revised, change the wording
of the definition of "regulatory study" in the manner
suggested by the Committee.
3. At the same time, the Department
will amend the wording of regulation 5(4) to meet the second point
raised by the Committee.
4. The Department apologises
for not indicating in the earlier memorandum that it intends to
amend the Regulations when a suitable opportunity arises to take
account of both these points made by the Committee.
10 January 2000