The Medicines for Human Use (Clinical Trials) Regulations 2004

The Act

7.—(1) Section 35 of the Act (supplementary provisions as to clinical trials and medicinal test on animals) shall be amended as follows.

(2) In subsection (1), omit “a clinical trial certificate or”.

(3) In subsection (2), omit paragraph (a).

(4) In subsection (4), omit the words from the beginning to “; and”.

(5) In subsection (5)—

(a) omit “a clinical trial or”;

(b) for paragraph (a), substitute the following paragraph—

“(a) an animal test certificate has been issued and is for the time being in force in respect of that test, and the test is to be carried out in accordance with that certificate, and;”

(c) in paragraph (b), omit “trial or”.

(6) In subsection (7)—

(a) for “sections 31 and 32” substitute “section 32”;

(b) omit “of a clinical trial or”; and

(c) in paragraph (a), omit “trial or”.

(7) In subsection (8), omit paragraph (a).

(8) In subsection (10), omit “any of the provisions of subsections (5) to (8) of section 31 of this Act, or”.