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The Good Laboratory Practice Regulations 1997

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Amendment of the Medicines (Applications for Grant of Product Licences—Products for Human Use) Regulations 1993

17.  The Medicines (Applications for Grant of Product Licences—Products for Human Use) Regulations 1993(1) shall be amended as follows—

(a)in paragraph (2) of regulation 1 (citation, commencement and interpretation), after the definition of “expert” there shall be inserted the following definition—

  • “principles of good laboratory practice” has the same meaning as in the Good Laboratory Practice Regulations 1997;; and

(b)in paragraph 17 of Schedule 1 (information, documents, samples and other material required in respect of applications), the words “referred to in that sub-paragraph” shall be omitted.

(1)

S.I. 1993/2538; there are no relevant amending instruments.

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