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The Medicines (Products for Human Use — Fees) Regulations 1991

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Variations of licences and certificates

7.  Subject to regulations 8, 9, 19 and 23, in connection with an application under section 30 of the Act for the variation of a provision of a product licence, a manufacturer’s licence or a wholesale dealer’s licence, and under section 39(4) for the variation of a clinical trial certificate, there shall be payable by the applicant—

(a)the fee prescribed in Part III of Schedule 1 in connection with that application; and

(b)in respect of any inspection of a description referred to in paragraph 1 of Schedule 2 made in connection with that application, the fee payable in accordance with paragraphs 2 to 5 of that Schedule.

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