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The Medicines for Human Use (Clinical Trials) Regulations 2004

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This is the original version (as it was originally made).

17.—(1) Amendments in section 129 (orders and regulations) as follows.

(2) Omit subsection (1) (powers to make regulations exercisable by the Ministers where not expressed to be otherwise exercisable).

(3) In subsection (2) (powers to make orders and regulations under the Act exercisable by statutory instrument), for the words from “this Act (other” to “section 120 of this Act)” substitute “any provision of this Act applied by regulation 47 of the Clinical Trials Regulations”.

(4) In subsection (3) (instruments which are subject to negative procedure), for paragraphs (a) to (c) substitute “an order or regulations made under any provision of this Act applied by regulation 46 of the Clinical Trials Regulations”.

(5) In subsection (4) (powers to make orders that include power to revoke or vary), for the words from “, other than” to “69(3), of this Act” substitute “of this Act applied by regulation 47 of the Clinical Trials Regulations”.

(6) In subsection (5) (powers to make regulations include power to make differential provision etc.), for “this Act” substitute “any provision of this Act applied by regulation 47 of the Clinical Trials Regulations”.

(7) In subsection (6) (duty to consult), for the words from the beginning to “effect) the Ministers” substitute—

  • “Before making any regulations or order under any provision of this Act applied by regulation 47 of the Clinical Trials Regulations, the persons.”

(8) Omit subsections (6A) and (7) (which apply only in relation to veterinary products or instruments made otherwise than under Part 8 of the Act).

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