Paragraph 4 Procedural provisions relating to proposals to grant, refuse to grant, vary, suspend or revoke manufacturing authorizations

(1)

This paragraph applies where, before 30th October 2005—

(a)

notification has been given to an applicant for, or holder of, a manufacturing authorization under paragraph 2 of Schedule 8 to the Clinical Trials Regulations;

(b)

the person has not given notice of his wish to—

(i)

appear before, or be heard by, a person appointed by the licensing authority; or

(ii)

make representations in writing to the licensing authority,

with respect to the decision or proposal referred to in the notification; and

(c)

the period of 28 days after the notification was given, or such extended period as the licensing authority has allowed, has not expired.

(2)

The applicant or holder may, by 30th November 2005—

(a)

give notice of his wish to appear before and be heard by a person appointed by the licensing authority; or

(b)

make representations in writing to the licensing authority.

(3)

If the applicant or holder gives notice under sub-paragraph (2)(a), he shall be treated as if he had given notice under paragraph 4(1)(a) of Schedule 8 to the Clinical Trials Regulations.