Medicines Act 1968

Procedure in case of urgency

10 The following provisions of this Schedule shall have effect where it appears to the licensing authority that in the interests of safety it is necessary to suspend a licence under Part II of this Act with immediate effect.

11 In the circumstances specified in paragraph 10 of this Schedule, the licensing authority may, notwithstanding anything in paragraphs 1 to 9 of this Schedule, suspend the licence with immediate effect for a period not exceeding three months.

12 If the licence is a product licence, the licensing authority shall report the suspension forthwith to the appropriate committee or, if for the time being there is no such committee, to the Commission.

13 If, after the suspension has taken effect, it appears to the licensing authority, or (in the case of a product licence) they are advised by the appropriate committee or by the Commission, that it is necessary to consider whether the licence ought to be further suspended, or ought to be revoked or varied, the licensing authority (subject to the next following paragraph) shall proceed in accordance with such of the provisions of paragraphs 1 to 9 of this Schedule as are applicable in the circumstances.

14 Where, in the circumstances specified in paragraph 13 of this Schedule, the licensing authority proceed as mentioned in that paragraph, and any proceedings under paragraphs 1 to 9 of this Schedule relating to a further suspension of the licence have not been finally disposed of before the end of the period for which the licence was suspended under paragraph 11 of this Schedule, or for which it has been further suspended under this paragraph, as the case may be, then, if it appears to the licensing authority to be necessary in the interests of safety to do so, the licensing authority may further suspend the licence for a period which (in the case of each such further suspension) shall not exceed three months.

15 The provisions of section 27(7) of this Act shall, with the necessary modifications, have effect for the purpose of determining the date on which, for the purposes of paragraph 14 of this Schedule, any proceedings are to be taken to be finally disposed of.