The Medicines for Human Use (Clinical Trials) Regulations 2004 No. 1031

SCHEDULE 9 MODIFICATIONS OF THE ENFORCEMENT PROVISIONS OF THE ACT SUBJECT TO WHICH THOSE PROVISIONS ARE APPLIED FOR THE PURPOSES OF THESE REGULATIONS

6.—(1) Amendments in section 111 (rights of entry) as follows.

(2) In subsection (1)(a) (entry to ascertain whether Act etc. contravened), for the words after “contravention” substitute “of any provisions of the Clinical Trials Regulations, or”.

(3) In subsection (1)(b) (entry for purposes of functions under the Act etc.), for “this Act or any such regulations or order” substitute “those Regulations or any of the provisions of this Act applied by regulation 47 or those Regulations”.

(4) In subsection (2)(a) (right to enter craft), for the words from “this Act or of any regulations” onwards substitute “the Clinical Trials Regulations;”.

(5) In subsection (3) (rights to enter premises conferred on persons authorised by licensing authority)—

(a) for “an applicant for a licence under Part II of this Act” substitute “a person applying for or requesting an authorisation under the Clinical Trials Regulations”, and

(b) for “application for the licence or certificate” substitute “application or request for the authorisation”.