Paragraph 12 Right to be heard by person appointed in relation to licence applications or proposals made before 30th October 2005

(1)

This paragraph applies where, before 30th October 2005—

(a)

the Medicines Commission have reported findings and advice to the licensing authority under—

(i)

section 21(4) of the Act; or

(ii)

paragraph 5 of Schedule 2 to the Act; and

(b)

the licensing authority have not notified the applicant or holder of its proposals following the advice of the Medicines Commission.

(2)

If the licensing authority propose to determine the application or matter in a way which differs from the advice of the Medicines Commission referred to in sub-paragraph (1)(a)—

(a)

the licensing authority shall notify the applicant or holder accordingly; and

(b)

the applicant or holder may, within the time allowed—

(i)

notify the licensing authority that he wishes to appear before and be heard by a person appointed by the licensing authority with respect to those proposals; or

(ii)

make written representations to the licensing authority.