SCHEDULES

SCHEDULE 5Review upon oral representations

Appointment of reviewers

2

1

The licensing authority must—

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.