OpenLegislation

Paragraph 6 Applications for, or proposals in relation to, marketing authorizations, where appropriate committee has given provisional opinion before 30th October 2005

Original text. Later amendments are not shown.

(1)

The appropriate committee shall—

(a)

take into account such representations as are made in accordance with paragraphs 3 to 5; and

(b)

report their findings and advice to the licensing authority, together with the reasons for their advice.

(2)

Subject to sub-paragraph (3), 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.

(3)

Paragraph 11(4)(a) of Schedule 2 to the Marketing Authorization Regulations shall apply as if, for “paragraph 8(4) to (7)” there were substituted “paragraphs 3 to 5 of Part 3 of Schedule 5 to the Medicines (Advisory Bodies) (No. 2) Regulations 2005”.