The Medicines for Human Use (Clinical Trials) Regulations 2004

[F15.—(1) Regulation 327 (powers of inspection, sampling and seizure) is amended as follows.U.K.

(2) In paragraph (1)—

(a)after sub-paragraph (b) omit “; or”;

(b)after sub-paragraph (c) insert “ ; or ” and the following sub-paragraph—

“(d)in order to verify any statement contained in an application or request for an authorisation under the Clinical Trials Regulations.”.

(3) After paragraph (2)(g) insert the following sub-paragraph—

“(h)information and documents relating to clinical trials”.

(4) In paragraph (3)—

(a)omit “or” following sub-paragraph (a); and

(b)following paragraph (b) insert “ ; or ” and the following sub-paragraph—

“(c)a medicinal product used, or intended to be used, in a clinical trial”.

(5) In paragraph (4)—

(a)after “require” insert “ — (a) ”; and

(b)after “control” insert “ ; or ” and the following sub-paragraph—

“(b)a person associated with a clinical trial to produce information or documents relating to the clinical trial which are in the person's possession or under the person's control”.

(6) In paragraph (5)(a) for “(2)(f) or (g)” substitute “ (2)(f), (g) or (h) ”.

(7) After paragraph (9) insert the following paragraph—

“(10) In this regulation, “a person associated with a clinical trial means any of the following—

(a)the sponsor of a clinical trial (within the meaning of regulation 3 of the Clinical Trials Regulations);

(b)any person who, under arrangements made with the sponsor of a clinical trial, carries out functions of the sponsor of the trial;

(c)in investigator for a clinical trial (within the meaning of regulation 2(1) of the Clinical Trials Regulations);

(d)any person, other than an investigator, who conducts a clinical trial;

(e)any person occupying premises at which a clinical trial is being conducted; or

(f)any person who, in the course of employment with a person listed in any of sub-paragraphs (a) to (e), undertakes activities in connection with a clinical trial.”.

(8) In regulation 335(6) (contravention due to fault of another person) omit “and” after sub-paragraph (e) and after sub-paragraph (f) insert “ ; and ” and the following sub-paragraph—

“(g)any obligation or prohibition under the Clinical Trials Regulations”.

(9) In regulation 336(3) (warranty as defence) omit “and” after sub-paragraph (c) and after sub-paragraph (d) insert “ ; and ” and the following sub-paragraph—

“(e)regulation 46 of the Clinical Trials Regulations (labelling)”.]

Textual Amendments