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SCHEDULES

[F1 SCHEDULE 2 U.K.SUSPENSION, REVOCATION OR VARIATION OF LICENCE

Textual Amendments

Modifications etc. (not altering text)

C1Sch. 2 applied (with modifications) (3.4.1992) by S.I. 1992/605, reg. 2(1)(2),Sch.

Sch. 2 extended (with modifications) (14.2.1994) by S.I. 1994/105, reg. 19, Sch.4

C2Sch. 2 amendment to earlier affecting provision SI 1992/605 Sch. (30.10.2005) by Medicines (Advisory Bodies) (No.2) Regulations 2005 (S.I. 2005/2754), reg. 1(2)(b), Sch. 4 para. 6(b)

C3Sch. 2 amendment to earlier affecting provision SI 1994/105 Sch. 4 (30.10.2005) by Medicines (Homoeopathic Medicinal Products for Human Use) Amendment Regulations 2005 (S.I. 2005/2753), regs. 1(1), 19(2)

Procedure in cases of urgencyU.K.

8U.K.Notwithstanding anything in paragraphs 1 to 7 of this Schedule, where it appears to the licensing authority that in the interests of safety it is necessary to suspend a licence under Part 2 of this Act with immediate effect, the licensing authority may do so, for a period not exceeding three months.

9U.K.If the licence is a product licence, the licensing authority shall report the suspension forthwith to the appropriate committee.

10.U.K.If, after the suspension has taken effect—

(a)it appears to the licensing authority; or

(b)in the case of a product licence, they are advised by the appropriate committee,

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 paragraph 11 of this Schedule) shall proceed in accordance with such of the provisions of paragraphs 1 to 7 of this Schedule as are applicable in the circumstances.

11.(1)This paragraph applies where, in the circumstances specified in paragraph 10 of this Schedule, the licensing authority proceed as mentioned in that paragraph and any proceedings under paragraphs 1 to 7 of this Schedule relating to a further suspension of the licence have not been finally disposed of before the end of the period—U.K.

(a)for which the licence was suspended under paragraph 8 of this Schedule; or

(b)for which it has been further suspended under this paragraph.

(2)If it appears to the licensing authority to be necessary in the interests of safety to do so, the authority may further suspend the licence for a period which (in the case of each such further suspension) shall not exceed three months.

(3)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 any proceedings are taken to be finally disposed of.]