The Medicines (Advisory Bodies) Regulations 2005

JurisdictionUK Non-devolved
CitationSI 2005/1094
Year2005

2005 No. 1094

MEDICINES

The Medicines (Advisory Bodies) Regulations 2005

Made 4th April 2005

Laid before Parliament 7th April 2005

The Secretary of State, being a Minister designated1for the purposes of section 2(2) of the European Communities Act 19722in relation to medicinal products, in exercise of the powers conferred by the said section 2(2), and of all other powers enabling him in that behalf, hereby makes the following Regulations:

S-1 Citation, commencement and interpretation

Citation, commencement and interpretation

1.—(1) These Regulations may be cited as the Medicines (Advisory Bodies) Regulations 2005 and, subject to paragraph (2), shall come into force on 30th October 2005.

(2) Regulation 7 shall come into force on 31st May 2005 for the purposes of making regulations under paragraph 6 of Schedule 1A to the Act, as inserted by that regulation.

(3) In these Regulations—

“the Act” means the Medicines Act 19683; and

“the Marketing Authorisation Regulations” means the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 19944.

S-2 Abolition of the Medicines Commission

Abolition of the Medicines Commission

2.—(1) The Medicines Commission is abolished.

(2) Section 2 of the Act (establishment of the Medicines Commission)5is hereby repealed.

S-3 Establishment of the Commission on Human Medicines

Establishment of the Commission on Human Medicines

3. After section 2 of the Act insert the following section—

S-2A

Establishment of the Commission on Human Medicines

2A.—(1) There shall be established a body of persons to be called the Commission on Human Medicines (referred to in this Act as “the Commission”) to perform the functions assigned to the Commission by or under this Act.

(2) The Ministers shall appoint the members of the Commission.

(3) The Commission shall have at least eight members.

(4) The Ministers shall appoint the chairmen of the Expert Advisory Groups referred to in paragraphs (a) to (c) of paragraph 4(1) of Schedule 1A to this Act as members of the Commission.

(5) The Ministers shall appoint one of the members of the Commission to be chairman of the Commission.”.

S-4 Functions of the Commission on Human Medicines

Functions of the Commission on Human Medicines

4. For section 3 of the Act (general functions of the Commission)6, substitute—

S-3

Functions of the Commission

3.—(1) The Commission shall give to any one or more of the Ministers specified in paragraphs (a) and (b) of section 1(1) of this Act advice on matters—

(a)

(a) relating to the execution of this Act,

(b)

(b) relating to the exercise of any power conferred by this Act,

(c)

(c) relating to the execution of the Marketing Authorisation Regulations or the Clinical Trials Regulations,

(d)

(d) relating to the exercise of any power conferred by those regulations, or

(e)

(e) otherwise relating to medicinal products,

where either the Commission consider it expedient, or they are requested by the Minister or Ministers in question, to do so.

(2) Without prejudice to the preceding subsection, and to any other duties or powers imposed or conferred on the Commission by or under this Act, the Marketing Authorisation Regulations or the Clinical Trials Regulations, it shall be the duty of the Commission—

(a)

(a) to—

(i) give advice with respect to safety, quality or efficacy in relation to medicinal products,

(ii) promote the collection and investigation of information relating to adverse reactions, for the purposes of enabling such advice to be given, and

(iii) undertake the functions mentioned in section 4(4) of this Act,

except in so far as those functions are for the time being assigned to a committee established under section 4 of this Act; and

(b)

(b) to advise the licensing authority in cases where the authority—

(i) are required by the provisions of Part 2 of this Act, or by the provisions of the Marketing Authorisation Regulations or the Clinical Trial Regulations, to consult the Commission with respect to any matter arising under those provisions, or

(ii) without being required to do so, elect to consult the Commission with respect to any matter arising under any of those provisions.”.

S-5 Amendment of section 4 of the Act

Amendment of section 4 of the Act

5.—(1) Section 4 of the Act (establishment of committees)7shall be amended as follows.

(2) In subsection (1), omit the words from “, having regard to” to “consider appropriate,”.

(3) In subsection (2)(a), before “or the Clinical Trials Regulations”, insert “, the Marketing Authorisation Regulations”.

(4) After subsection (4), insert the following subsection—

S-4A

“4A A committee established under this section shall have at least eight members.”.

(5) For subsection (6), substitute—

S-6

“6 In this Act “the appropriate committee”, for the purposes of any provision of this Act under which a function falls to be performed, means—

(a) in a case where—

(i) a committee has been established under this section for purposes which consist of or include any of those specified in subsection (3) of this section, and

(ii) the authority performing that function considers it to be the appropriate committee in the circumstances,

that committee; and

(b) in any other case, the Commission.”.

S-6 Amendment of section 5 of the Act

Amendment of section 5 of the Act

6.—(1) Section 5 of the Act (supplementary provisions as to Commission and committees) shall be amended as follows.

(2) In subsection (1), for “Schedule 1” substitute “Schedule 1A”.

(3) For subsection (2) substitute—

S-2

“2 The Commission shall, at such time in each year as the Ministers may direct, send to the Ministers specified in paragraphs (a) and (b) of section 1(1) of this Act a report with respect to—

(a) the performance of their functions; and

(b) the performance of functions by any Expert Advisory Group appointed by them under paragraph 3 of Schedule 1A to this Act, including any Expert Advisory Group which is jointly appointed by them and another Advisory Body or Bodies,

and the Secretary of State shall lay before Parliament a copy of every such report.”.

(4) For subsection (3) substitute—

S-3

“3 Each committee established under section 4 of this Act shall, at such time in each year as the Ministers may direct, send to the Ministers specified in paragraphs (a) and (b) of section 1(1) of this Act a report with respect to—

(a) the performance of their functions; and

(b) the performance of functions by any Expert Advisory Group appointed by them under paragraph 3 of Schedule 1A to this Act, including any Expert Advisory Group which is jointly appointed by them and another Advisory Body or Bodies,

and the Secretary of State shall lay before Parliament a copy of every such report.”.

(5) In subsection (4), in paragraph (a), for “Schedule 1” substitute “Schedule 1A”.

S-7 Provisions relating to Commission on Human Medicines and other committees

Provisions relating to Commission on Human Medicines and other committees

7.—(1) Schedule 1 to the Act (provisions relating to Medicines Commission and committees) is hereby repealed.

(2) After Schedule 1 to the Act, insert the following Schedule—

SCHEDULE 1A

Section 5

PROVISIONS RELATING TO COMMISSION AND COMMITTEES

1

Interpretation

1. In this Act, “Advisory Body” means the Commission or a committee established under section 4 of this Act.

2

Co-opted members

2.—(1) Subject to the approval of the Secretary of State, at any meeting of an Advisory Body, that Advisory Body may co-opt additional members.

(2) A co-opted member shall hold office only in relation to the meeting for which he is co-opted.

3

Expert Advisory Groups

3.—(1) Subject to paragraph 4 of this Schedule, an Advisory Body, or any two or more Advisory Bodies acting jointly, may, subject to the approval of the Secretary of State, appoint sub-committees, to be known as Expert Advisory Groups.

(2) The Secretary of State may direct an Advisory Body to appoint an Expert Advisory Group to advise on such matters as may be specified in the direction.

(3) An Expert Advisory Group may include or consist of persons who are not members of the Advisory Body or Bodies which appointed that Expert Advisory Group.

(4) Subject to paragraph 4(2) of this Schedule, the Advisory Body or Bodies which appointed the Expert Advisory Group shall appoint one of the members of the Expert Advisory Group as chairman.

(5) At any meeting of an Expert Advisory Group, the chairman of that Group may, after consulting the chairman or chairmen of the Advisory Body or Bodies which appointed that Group, co-opt additional members of that Group.

(6) Members co-opted in accordance with sub-paragraph (5) of this paragraph shall hold office only in relation to the meeting for which they are co-opted.

4

Appointment by the Commission of Expert Advisory Groups

4.—(1) The Commission shall establish—

(a)

(a) an Expert Advisory Group to be called “the Biologicals Expert Advisory Group”, to advise on the safety, quality and efficacy of medicinal products of biological or bio-technological origin, including vaccines;

(b)

(b) an Expert Advisory Group to be called “the Chemistry, Pharmacy and Standards Expert Advisory Group”, to advise on the quality, and quality in relation to safety and efficacy, of medicinal products which are the subject of an application for a product licence under this Act, a marketing authorization under the Marketing Authorisation Regulations, or a request for authorisation pursuant to regulation 17 of the Clinical Trials Regulations;

(c)

(c) an Expert Advisory Group to be called “the Pharmacovigilance Expert Advisory Group”, to advise on pharmacovigilance and other issues relating to the safety of medicinal products; and

(d)

(d) such other Expert Advisory Groups as it considers appropriate.

(2) The chairmen of the Expert Advisory Groups referred to in paragraphs (a) to (c) of sub-paragraph (1) above shall be appointed by the Ministers.

5

Delegation of functions by Advisory Bodies

5.—(1) Subject to sub-paragraph (2) of this...

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