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The Medicines for Human Use (Clinical Trials) Regulations 2004

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7.—(1) Amendments in section 112 (power to inspect, take samples and seize goods and documents) as follows.

(2) In subsection (1) (inspection for purpose of ascertaining whether Act etc. contravened), for the words before paragraph (a) substitute—

  • For the purposes of ascertaining whether there is or has been a contravention of the Clinical Trials Regulations, any person duly authorised in writing by an enforcement authority shall have a right to inspect—.

(3) In subsection (2) (items of which samples may be taken), before the word “or” at the end of paragraph (a) insert—

(aa)a medicinal product used or intended to be used in a clinical trial,.

(4) In subsection (3) (right to require production etc. of books and documents), after paragraph (a) insert—

(a)to require—

(i)the sponsor of a clinical trial,

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

(iii)an investigator for a trial,

(iv)any person, other than an investigator, who conducts a trial,

(v)any person occupying premises at which a clinical trial is being conducted, or

(vi)any person who, in the courses in the course of their employment with a person of a description specified in any of sub-paragraphs (i) to (v) of this paragraph, undertakes activities in connection with a clinical trial,

to produce any books or documents relating to the clinical trial which are in his possession or under his control;.

(5) In subsection (3)(b) (powers to take copies of documents produced), for “the preceding paragraph” substitute “paragraph (a) or (aa) of this subsection;”.

(6) In subsection (3), after paragraph (b) insert—

(c)to take possession of any book or document produced under paragraph (a) or (aa) of this subsection..

(7) In subsection (4) (right to seize items and documents), for “offence under this Act is” substitute—

  • offence—

    (a)

    under the Clinical Trials Regulations, or

    (b)

    under section 114, 118 or 123 of this Act,

    is.

(8) In that subsection, for “under this Act” (in the second place) substitute “under those Regulations or under any of the provisions of this Act applied by regulation 47 of those Regulations”.

(9) In subsection (5) (opening of containers), for “this Act and any regulations or order made thereunder” substitute “the Clinical Trials Regulations”.

(10) In subsection (7) (rights of persons authorised by licensing authority)—

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

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

(11) In subsection (9) (Schedule 3 to have effect in relation to samples obtained for purposes of the Act), for “this Act” (in the second place) substitute “the Clinical Trials Regulations”.

(12) After subsection (9) insert—

(10) In this section “clinical trial”, and “investigator” and “sponsor” in relation to a clinical trial, have the meaning given by the Clinical Trials Regulations.

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