The Medicines for Human Use (Clinical Trials) Regulations 2004

The Act

1.—(1) Section 3 of the Act (general functions of the Medicines Commission)(1) is amended as follows—

(2) In subsection (1), for the words from “advice” to “products, where” substitute—

• “advice on matters—

  (a)

  relating to the execution of this Act,

  (b)

  relating to the exercise of any power conferred by this Act,

  (c)

  relating to the execution of the Clinical Trials Regulations,

  (d)

  relating to the exercise of any power conferred by those regulations, or

  (e)

  otherwise relating to medicinal products,

  where.”

(3) In subsection (2), after “by or under this Act” insert “or the Clinical Trials Regulations”.

(4) For subsection (2)(d) substitute—

“(d) to advise the licensing authority in cases where the authority—

(i) are required by the provisions of Part II of this Act, or by the provisions of the Clinical Trial Regulations, to consult the Commission with respect to any matter arising under those provisions; or

(ii) without being required to do so, elect to consult the Commission with respect to any matter arising under any of those provisions.”

(1)

Section 3 has effect as if any reference to the Act included a reference to the Medicines for Human Use (Marketing Authorisations Etc) Regulations 1994 (S.I. 1994/3144) (“the 1994 Regulations”); see regulation 9(1) of the 1994 Regulations.