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

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5.  For section 30 of the Act (variation of licence on application of holder), substitute—

Variation of licence on application of holder

30.  (1)  This section applies if the holder of a licence under this Part applies to the licensing authority for the licence to be varied.

(2) The application must—

(a)be in writing,

(b)specify the required variation,

(c)be signed by or on behalf of the applicant,

(d)be accompanied by such information as is reasonably required to enable the licensing authority to consider the application, and

(e)if there is a requirement in force under section 1(1)(a) of the Medicines Act 1971(1) to pay a fee in respect of the application, be accompanied by the required fee.

(3) The licensing authority must consider any application properly made under this section.

(4) If subsection (5) applies, they must either vary the licence or refuse to vary it before the end of the period allowed for considering the application.

(5) This subsection applies to a variation which would have the effect of altering—

(a)the types of medicinal product,

(b)any operation carried out under the licence,

(c)any premises, or

(d)any equipment or facilities,

in respect of which the licence was granted.

(6) If the licensing authority considers that it is necessary for them to conduct an inspection of any premises to which the application relates, the period allowed is 90 days beginning with the date on which they receive the application.

(7) Otherwise, the period allowed is 90 days beginning with that date.

(8) The licensing authority may give the applicant written notice requiring him to give them such further information in connection with the application as they consider reasonable.

(9) The period allowed for consideration stops running when a notice is given under paragraph (8) 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

(10) Nothing in this section affects the powers conferred by section 28..

(1)

Section 24 was amended by S.I. 1977/1050, 1994/276, 2002/236 and 2005/1094.

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