Medicines Act 1971
| Jurisdiction | UK Non-devolved |
| Citation | 1971 c. 69 |
| Year | 1971 |
for the payment and recovery of such fees as are prescribed by the regulations in connection with any application in pursuance of the Medicines Act 1968 (hereafter in this Act referred to as “the principal Act”) for a licence, certificate or direction under Part II of that Act or for the variation or renewal of such a licence or certificate; in connection with applications for the grant, renewal or variation of any such licence; orduring the currency of any such licence;for the payment and recovery of such annual or other periodic fees (in addition to fees payable by virtue of regulations made under paragraph (aa) above) as are prescribed by the regulations in connection with the holding of any such licence and for the payment and recovery of a penalty for failure to pay a fee so prescribed at the time at which it should have been paid;the United Kingdom turnover of a medicinal product or a number of medicinal products to which the licence relates;the United Kingdom turnover of all medicinal products to which licences held by the holder of the licence relate;fees received by the holder of the licence in respect of a medicinal product or a number of medicinal products to which the licence relates;fees received by the holder of the licence in respect of all medicinal products to which licences held by the holder of the licence relate;if insufficient evidence is submitted for the calculations that would be required by regulations made under paragraph (ac) above; orif no evidence is submitted for those calculations;for the payment of any such fee by instalments, and for the refund F2, adjustment, set-off, waiver or reduction of the whole or part of any such fee, in such cases as may be determined by or under the regulations;(1A) In subsection (1) above—
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“ medicinal product ” includes—
- (a) any article or substance in relation to which provisions of Part II of the principal Act have effect by virtue of an order under section 104 or 105 of that Act;
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(b)
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“ United Kingdom turnover ” means the value, as determined under the regulations, of the aggregate of all quantities of a medicinal product, other than quantities which the regulations direct to be excluded from the calculation, which, during a period specified in the regulations—
- (a) in the case of a product licence, are sold or supplied in the United Kingdom by the holder of the licence or such other person as may be prescribed by the regulations;
- (b) in...
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