The Medicines for Human Use (Clinical Trials) Regulations 2004

2.—(1) Amendments in section 107 (validity of decisions and related proceedings) as follows.U.K.

(2) In subsection (1), for “Part II of this or of a Minister under section 75 of this Act, and the validity of any licence or certificate” substitute “ the Clinical Trials Regulations, and the validity of any authorisation ”.

(3) In subsections (2)(a) and (3)(b), for “this Act” substitute “ the Clinical Trials Regulations ”.

(4) In subsection (2)(b), for “this Act or of any regulations made under this Act” substitute “ the Clinical Trials Regulations ”.

(5) In subsection (4) (effect of quashing a decisions) substitute—

(4) Subsections (4A) and (4B) of this section apply where a decision—

(a)to grant or issue an authorisation, or

(b)to give notice accepting a request for an authorisation, is quashed under this section.

(4A) Any authorisation granted or issued, or notice given, in pursuance of the decision shall be void.

(4B) Any proceedings on the application, or request, for the authorisation may be continued as if not such decision had been made..