The Human Medicines Regulations 2012

PART 2 U.K. Administration

Commission on Human Medicines U.K.

9.—(1) There is to continue to be a body known as the Commission on Human Medicines (referred to in these Regulations as “ the Commission”).

(2) The Commission is to perform the functions conferred on it by these Regulations.

(3) The Commission is to have at least eight members.

(4) The members of the Commission are to be appointed by the Ministers.

(5) The Ministers must appoint one of the members of the Commission to chair it.

(6) The Ministers must consult the Scottish Ministers before exercising their functions under paragraphs (4) and (5).

Functions of the Commission U.K.

10.—(1) The Commission must give advice to either or both of the Ministers in relation to the matters listed in paragraph (2) if—

(a) the Minister, or Ministers, request it; or

(b) the Commission considers it appropriate to give it.

(2) The matters mentioned in paragraph (1) are matters—

(a) relating to the execution of any duty imposed by these Regulations or the Clinical Trials Regulations;

(b) relating to the exercise of any power conferred by these Regulations or the Clinical Trials Regulations; or

(c) otherwise relating to medicinal products.

(3) Without prejudice to paragraphs (1) and (2), or to any other functions conferred on the Commission by or under these Regulations, the Commission must—

(a) give advice with respect to the safety, quality and efficacy of medicinal products; and

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

(4) The Commission must also advise the licensing authority if—

(a) the licensing authority is required under Schedule 11 (advice and representations) or the Clinical Trials Regulations to consult the Commission about any matter arising under those provisions; or

(b) the licensing authority consults the Commission about any matter arising under those provisions.

British Pharmacopoeia Commission U.K.

11.—(1) There is to continue to be a committee called the British Pharmacopoeia Commission (referred to as “ the BPC” in this regulation).

(2) The BPC is to continue to have the following functions—

(a) the preparation under regulation 317(1) of editions of the British Pharmacopoeia;

(b) the preparation of compendia under regulation 317(3);

(c) the preparation under regulation 318 (which provides for the preparation and publication of lists of names to be used as headings to monographs in the British Pharmacopoeia) of lists of names; and

(d) the preparation of any other document under regulation 319.

(3) The BPC is to have at least eight members.

(4) The members of the BPC are to be appointed by the Ministers.

(5) The Ministers must appoint one of the members of the BPC to chair it.

(6) The Ministers must consult the Scottish Ministers before exercising their functions under paragraphs (4) and (5).

(7) In this regulation, a reference to preparation includes revision or amendment.

Reporting to Ministers U.K.

12.—(1) In this Part “ advisory body” means—

(a) the Commission, or

(b) the British Pharmacopoeia Commission.

(2) Each advisory body must give a report to the Ministers each year about—

(a) the performance of its functions; and

(b) the performance of the functions of any expert advisory group appointed by it under regulation 14 (including any expert advisory group appointed jointly with the other advisory body).

(3) Each advisory body must give its report to the Ministers at the time specified by the Ministers.

(4) The Secretary of State must lay a copy of each report before Parliament.

Co-option of additional members of advisory bodies U.K.

13.—(1) An advisory body may co-opt one or more additional members for the purposes of a meeting.

(2) A person co-opted as a member of an advisory body for the purposes of a meeting ceases to be a member at the end of the meeting.

Appointment of expert advisory groups U.K.

14.—(1) An advisory body, or the advisory bodies acting jointly, may with the approval of the licensing authority appoint one or more sub-committees, to be known as expert advisory groups.

(2) The licensing authority may direct an advisory body to appoint an expert advisory group to advise on the matters 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 the expert advisory group.

(4) The advisory body or bodies which appointed the expert advisory group must appoint a member of the group as its chair.

(5) The chair of an expert advisory group may co-opt additional members of the group for the purposes of a meeting.

(6) Before co-opting additional members under paragraph (5) the chair of the group must consult the chair of the advisory body or bodies which appointed the group.

(7) A person co-opted as a member of an expert advisory group for the purposes of a meeting ceases to be a member of the group at the end of the meeting.

Delegation of functions to expert advisory groups U.K.

15.—(1) An advisory body may delegate any of its functions, other than the functions specified in paragraph (2), to an expert advisory group.

(2) The functions which may not be delegated are functions of providing advice to the licensing authority in any case where the licensing authority is required to consult the advisory body under—

(a) Schedule 11 (advice and representations); and

(b) the Clinical Trials Regulations.

(3) But an advisory body may arrange for an expert advisory group to provide advice to the advisory body in relation to the performance of a function referred to in paragraph (2).

Further provision about advisory bodies and expert advisory groups etc U.K.

16.  Schedule 2 (which makes further provision about advisory bodies and expert advisory groups, and provision about payment and expenses of expert committees appointed by the licensing authority) has effect.