The Medicines (Advisory Bodies) (No. 2) Regulations 2005

7.—(1) The Unlicensed Medicinal Products for Human Use (Transmissible Spongiform Encephalopathies) (Safety) Regulations 2003(1) shall be amended as follows.

(2) In regulation 1 (citation, commencement and interpretation), in paragraph (2)—

(a) after the definition of “the 1994 Regulations”, insert the following definition—

““the appropriate committee” means—

(a)

in a case where—

(i)

a committee has been established under section 4 of the Act for purposes which consist of or include any of those specified in subsection (3) of that section, and

(ii)

the appropriate Minister considers it to be the appropriate committee in the circumstances,

that committee; and

(b)

in any other case, the Commission on Human Medicines established by section 2A of the 1968 Act;”; and

(b) omit the definition of “CSM”.

(3) In regulation 3 (procedure for determinations of compliance with the TSE Guideline)—

(a) in sub-paragraph (3)(b)(ii), for “CSM” (in both places where it appears), substitute “appropriate committee”;

(b) in paragraph (4), for “CSM”, substitute “appropriate committee”;

(c) in paragraph (5), for “CSM” (in both places where it appears), substitute “appropriate committee”;

(d) in paragraph (7), for “CSM”, substitute “appropriate committee”.

(e) in paragraph (8), for “CSM” (in each place where it appears), substitute “appropriate committee”.

(1)

S.I. 2003/1680, to which there are amendments not relevant to these regulations.