SCHEDULE 5 TRANSITIONAL PROVISIONS

PART 3 TRANSITIONAL PROVISIONS IN RELATION TO THE GRANT, RENEWAL, REVOCATION, SUSPENSION OR VARIATION OF MARKETING AUTHORIZATIONS UNDER THE MARKETING AUTHORIZATION REGULATIONS

3 Applications for, or proposals in relation to, marketing authorizations, where appropriate committee has given provisional opinion before 30th October 2005
(1) This paragraph applies if the applicant or holder—
(a) gave notice of his wish to make written or oral representations to the appropriate committee before 30th October 2005; or
(b) gives notice under paragraph 2(2) or (4).
(2) The applicant or holder shall, before 31st May 2006, provide the appropriate committee with—
(a) his written representations, or any additional written representations, if he provided written representations before 30th October; or
(b) a summary of the oral representations he intends to make,
and any documents on which he wishes to rely in support of those representations.
(3) If the applicant or holder so requests, the appropriate committee may extend the time limit referred to in sub-paragraph (2), up to a maximum of twelve months from 30th November 2005.
(4) The applicant or holder may not submit any additional written representations or documents once the time limit referred to in sub-paragraphs (2) and (3) has expired, except with the permission of the appropriate committee.