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The Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005

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3.  Section 20 of the Act (grant or refusal of licence)(1) is amended as follows—

(a)in subsection (1), for “the last preceding section,”, substitute “sections 8(2E) and (3E) and 19,”; and

(b)after subsection (1), insert—

(1A) The licensing authority must either grant or refuse any application for a licence under this Part, before the end of a period of 90 days from the date upon which they receive the application.

(2B) If there are requirements in force under section 18 that apply to the application, subsection (1A) applies only if the requirements have been met

(2C) If a notice under section 44 requires the applicant to provide the licensing authority with information, the period specified in subsection (1) stops running when the notice is given, and does not start running again until—

(a)the licensing authority receives the information; or

(b)the applicant has shown to the reasonable satisfaction of the licensing authority why he is unable to provide it..

(1)

Section 20 was amended by S.I. 1977/1050 and 2005/1094.

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