The Human Medicines Regulations 2012

This section has no associated Explanatory Memorandum

2.—(1) The licensing authority must—U.K.

(a)appoint a panel of at least two persons (“the reviewers”) to conduct the review; and

(b)provide facilities for the applicant to have the opportunity to appear before the reviewers.

(2) A person must not be appointed under sub-paragraph (1) if within the period of one year immediately preceding that time the person has been a member of—

(a)the Commission;

(b)an expert committee appointed by the licensing authority;

(c)an expert advisory group;

(d)the British Pharmacopoeia Commission or any of its sub-committees;

(e)the Advisory Board on the Registration of Homoeopathic Products formerly established under section 4 of the Medicines Act 1968; or

(f)the Herbal Medicines Advisory Committee formerly established under section 4 of the Medicines Act 1968.

(3) A person appointed under sub-paragraph (1) must not be an officer or servant of a Minister of the Crown, the Scottish Ministers, the Welsh Ministers or a Northern Ireland Minister.