The Medicines for Human Use (Clinical Trials) Regulations 2004

Regulation 47(1)

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

1.  The modifications of the Act mentioned in regulation 47 are as follows.

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

(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.”.

3.  For section 108 (enforcement in England and Wales) substitute—

“(1) It shall be the duty of the Secretary of State to enforce in England, or to secure the enforcement in England of, the provisions of the Clinical Trials Regulations.

(2) It shall be the duty of the National Assembly for Wales to enforce in Wales, or to secure the enforcement in Wales of, the provisions of the Clinical Trials Regulations”.

4.  In section 109 (enforcement in Scotland), for subsections (1) to (3), substitute—

“(1) It shall be the duty of the Scottish Ministers to enforce in Scotland, or to secure the enforcement in Scotland of, the provisions of the Clinical Trials Regulations.”.

5.  For section 110 (enforcement in Northern Ireland) substitute—

“It shall be the duty of the Department for Health, Social Services and Public Safety to enforce in Northern Ireland, or to secure the enforcement in England and Wales of, the provisions of the Clinical Trials 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”.

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.”

8.—(1) Amendments in section 115 (analysis of samples) as follows.

(2) In subsection (7) (certificate to be in prescribed form and signed), for “form prescribed by the Ministers” substitute “prescribed form”.

(3) Omit subsection (9) (regulations under subsection (5) to be made by the Ministers).

9.—(1) Amendments in section 116 (liability to forfeiture under the Customs and Excise Management Act 1979) as follows.

(2) For “this Act” (in both places) substitute “the Clinical Trials Regulations”.

(3) After subsection (3) insert—

“(4) In this section “the Ministers” means the Secretary of State and the Department for Health, Social Services and Public Safety, acting jointly.”.

10.  In section 118(1)(b) (restrictions on disclosing of information obtained in pursuance of the Act), for “this Act” substitute “the Clinical Trials Regulations or any provision of this Act applied by regulation 47 of those Regulations”.

11.—(1) Amendments in section 119 (protection for officers of enforcement authorities) as follows.

(2) In each of subsections (1) and (2) (relief from personal liability and power of authority to indemnify officer)—

(a) for “this Act” (in the first place) substitute “relevant legislation”, and

(b) for “this Act” (in the second place) substitute “that legislation”.

(3) In subsection (3) (meaning of “officer”), for “this Act” substitute “relevant legislation”.

(4) After subsection (3) insert—

“(4) In this section “relevant legislation” means—

(a) the Clinical Trials Regulations, or

(b) any provision of this Act applied by regulation 47 of those Regulations.”

12.—(1) Amendments in section 121 (contravention due to fault of other person) as follows.

(2) In subsection (1) (where a person is guilty of an offence due to act or default of another, the other is also guilty of the offence), for “to which this section applies constitutes an offence under this Act” substitute “of the Clinical Trials Regulations constitutes an offence under those Regulations”.

(3) In subsection (2) (defence of due diligence where contravention due to act or default of another), for “this Act in respect of a contravention of a provision to which this section applies” substitute “the Clinical Trials Regulations in respect of a contravention of a provision of those Regulations”.

(4) Omit subsection (4) (provisions to which section applies).

13.—(1) Amendments in section 122 (warranty as defence) as follows.

(2) In subsection (1), for “this Act in respect of a contravention of a provision to which this section applies” substitute “the Clinical Trials Regulations in respect of a contravention of regulation 46 of those Regulations”.

(3) Omit subsection (2) (provisions to which section applies).

14.—(1) Amendments in section 124 (offences by bodies corporate) as follows.

(2) In subsection (1), for “this Act” substitute “the Clinical Trials Regulations, or under section 114, 118 or 123 of this Act,”.

(3) After subsection (2) insert—

“(2A) In subsections (1) and (2) of this section “body corporate” includes a Scottish partnership and “director”, in relation to such a partnership, includes any of its partners.”

15.—(1) Amendments in section 125 (prosecutions) as follows.

(2) In each of subsections (1) and (2) (time limits in England and Wales, and in Scotland), for “under this Act” substitute “under the Clinical Trials Regulations, or for an offence under section 114, 118 or 123 of this Act,”.

(3) Omit subsections (3) to (7).

16.  In section 127 (service of documents)—

(a) for “any provision of this Act” substitute “relevant legislation”, and

(b) at the end add—

“In this section “relevant legislation” means any provision of the Clinical Trials Regulations or any provision of this Act applied by regulation 47 of those Regulations.”

17.—(1) Amendments in section 129 (orders and regulations) as follows.

(2) Omit subsection (1) (powers to make regulations exercisable by the Ministers where not expressed to be otherwise exercisable).

(3) In subsection (2) (powers to make orders and regulations under the Act exercisable by statutory instrument), for the words from “this Act (other” to “section 120 of this Act)” substitute “any provision of this Act applied by regulation 47 of the Clinical Trials Regulations”.

(4) In subsection (3) (instruments which are subject to negative procedure), for paragraphs (a) to (c) substitute “an order or regulations made under any provision of this Act applied by regulation 46 of the Clinical Trials Regulations”.

(5) In subsection (4) (powers to make orders that include power to revoke or vary), for the words from “, other than” to “69(3), of this Act” substitute “of this Act applied by regulation 47 of the Clinical Trials Regulations”.

(6) In subsection (5) (powers to make regulations include power to make differential provision etc.), for “this Act” substitute “any provision of this Act applied by regulation 47 of the Clinical Trials Regulations”.

(7) In subsection (6) (duty to consult), for the words from the beginning to “effect) the Ministers” substitute—

• “Before making any regulations or order under any provision of this Act applied by regulation 47 of the Clinical Trials Regulations, the persons.”

(8) Omit subsections (6A) and (7) (which apply only in relation to veterinary products or instruments made otherwise than under Part 8 of the Act).

18.—(1) Amendments in section 131 (meaning of “wholesale dealing” and “retail sale” etc).

(2) Omit subsection (1) (meaning of “wholesale dealing”).

(3) In subsection (2) (purposes referred to in subsections (1) and (3)), for “the preceding subsection” substitute “subsection (3) of this section”.

(4) In subsection (3) (meaning of “retail sale”), for “In this Act” substitute “In the provisions of this Act applied by regulation 47 of the Clinical Trials Regulations,”.

(5) Omit subsection (4) (meaning of “supply in circumstances corresponding to retail sale”).

19.—(1) Amendments in section 132(1) (interpretation) as follows.

(2) At the beginning, for “In this Act,” substitute “In the provisions of this Act applied by regulation 47 of the Clinical Trials Regulations,”.

(3) In the definition of “enforcement authority”, for the words from “power” to “or under” substitute “to enforce the provisions of the Clinical Trials Regulations is imposed by”.

(4) After the definition of “manufacture” insert—

““medicinal product” means—

(a)

anything that is a medicinal product within the meaning given by Article 1 of Directive 2001/83/EC, and

(b)

anything that is an investigational medical product for the purposes of the Clinical Trials Regulations;”.

(5) Omit the definition of “offence under this Act”.

(6) For the definition of “prescribed” substitute—

““prescribed” means prescribed by regulations made by the Secretary of State and the Department for Health, Social Services and Public Safety, acting jointly;”.

20.—(1) Amendments in Schedule 3 (sampling) as follows.

(2) In paragraph 1(1)(a), for the words from “this Act or of any regulations” onwards substitute “the Clinical Trials Regulations, or”.

(3) In paragraph 1(1)(b), for the words from “of their functions” onwards substitute “(in this Schedule referred to as “the relevant enforcement authority”) of their functions under those Regulations or under any provision of this Act applied by regulation 47 of those Regulations,”.

(4) In paragraph 16, omit “the relevant enforcement officer is a Minister or the Pharmaceutical Society, and”.

(5) Omit paragraph 17.

(6) In paragraph 19(3), for “form prescribed by the Ministers” substitute “prescribed form”.

(7) Omit paragraph 20(2).

(8) In each of paragraphs 21 and 22, for “under this Act” substitute “under the Clinical Trials Regulations, or under section 114, 118 or 123 of this Act,”.

(9) In paragraph 24(1), for “under this Act,” substitute “under the Clinical Trials Regulations or under section 114, 118 or 123 of this Act,”.

(10) In paragraph 27 (power to apply Schedule with modifications), for “Ministers” substitute “Secretary of State and the Department for Health, Social Services and Public Safety, acting jointly,”.