Paragraph 8 Marketing authorisation applications or proposals where appropriate committee has given advice to the licensing authority before 30th October 2005

(1)

This paragraph applies where the licensing authority have not, before 30th October 2005, notified the applicant for, or holder of, the authorization of the advice referred to in paragraph 7.

(2)

If they have not done so before 30th October 2005, the licensing authority shall—

(a)

in the case of an application for the grant of an authorization, grant or refuse the application, or grant it with provisions otherwise than in accordance with the application;

(b)

in the case of an application for the renewal of an authorization, renew the application (whether or not in accordance with the application), or decide that they are still minded to refuse it;

(c)

in the case of a proposal to revoke, suspend or vary an authorization, decide whether to proceed further with their proposal.

(3)

The licensing authority shall notify the applicant or holder of the advice referred to in paragraph 7 of this Schedule and of its decision—

(a)

made before 30th October 2005 under paragraph 7 of Schedule 2 to the Marketing Authorization Regulations; or

(b)

made under sub-paragraph (2)(a), (b), or (c).

(4)

If the applicant or holder is dissatisfied, he may, within the time allowed, give notice to the licensing authority that he wishes to make written or oral representations to the Commission with respect to the licensing authority’s decision.