# The Medicines (Advisory Bodies) (No. 2) Regulations 2005, Paragraph 2: Applications for, or proposals in relation to, marketing authorizations, where appropriate committee has given provisional opinion before 30th October 2005


(1) This sub-paragraph applies where, before 30th October 2005—
(a) the applicant or holder has not given notice of his wish to make written or oral representations in relation to the matters set out in the notification referred to in paragraph 1(b); and
(b) the period of 28 days after the giving of the notification, or such longer period as the licensing authority has allowed in the particular case, has not expired.
(2) Where sub-paragraph (1) applies, the applicant or holder may, by 30th November 2005, give notice of his wish to make oral or written representations to the appropriate committee.
(3) This sub-paragraph applies where, before 30th October 2005—
(a) the applicant or holder made written representations in relation to the matters set out in the notification referred to in paragraph 1(b); and
(b) those representations were made within—
(i) the period of 28 days from the giving of the notification; or
(ii) within such longer period as the licensing authority had allowed.
(4) Where sub-paragraph (3) applies, the applicant or holder may, by 30th November 2005, give notice of his wish to make—
(a) oral representations; or
(b) additional written representations,
to the appropriate committee.
(5) Where the applicant or holder does not give notice in accordance with sub-paragraph (2) or (4), the appropriate committee shall—
(a) if the applicant or holder made written representations before 30th October, take those representations into account; and
(b) report their findings and advice to the licensing authority, together with the reasons for their advice.
(6) Subject to sub-paragraph (7), the report of the appropriate committee shall be treated as if it has been given under paragraph 8(8)(b) of Schedule 2 to the Marketing Authorization Regulations.
(7) Paragraph 11(4)(a) of Schedule 2 to the Marketing Authorization Regulations shall apply as if for “any representations in accordance with paragraph 8(4) to (7)” there were substituted “written representations as referred to in paragraph 2(3) of Part III of Schedule 5 to the Medicines (Advisory Bodies) (No. 2) Regulations 2005”.

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Source: https://www.legislation.gov.uk/uksi/2005/2754/schedule/5/part/3/paragraph/2 (the official version)
Page: https://openlegislation.uk/medicines-advisory-bodies-no-2-regulations-2005/schedule-5/part-3/paragraph-2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.