Joint Committee on Statutory Instruments Seventh Report


Further memorandum by the Department of Health

THE GOOD LABORATORY PRACTICE REGULATIONS 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


 
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