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The Medicines for Human Use and Medical Devices (Fees Amendments) (No.2) Regulations 2007
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- UK Statutory Instruments
- 2007 No. 803
- Regulation 10
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Amendment of Schedule 6 to the Medicines Fees RegulationsU.K.
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10. In Schedule 6 to the Medicines Fees Regulations (adjustment, reduction or refund of periodic fees), after paragraph 1 insert the following paragraph—
“1A.—(1) This paragraph applies to periodic fees payable in connection with a manufacturer's licence or a wholesale dealer's licence which relates to exempt imported products.
(2) If during a fee period the number of special import notices given by a licence holder is greater than the estimated number notified by the licensing authority in accordance with paragraph 9B of Part III of Schedule 3, the periodic fee payable in relation to that period shall be increased by the difference, if any, between the amount payable in accordance with that paragraph and the amount which would have been payable if the estimated number notified by the licensing authority for that fee period had been the same as the actual number of notices given during that year.
(3) If during a fee period the number of special import notices given by a licence holder is less than the estimated number notified by the licensing authority in accordance with paragraph 9B of Part III of Schedule 3, the licensing authority shall refund the difference, if any, between the amount payable in accordance with that paragraph and the amount which would have been payable if the estimated number notified by the licensing authority for that fee period had been the same as the actual number of notices given during that year.”.
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