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The Medicines (Fees Relating to Medicinal Products for Animal Use) Regulations 1989
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2. The Licensing Authority may waive or reduce the payment of any capital fee payable under these Regulations in circumstances where–
(a)in its opinion the interests of human or animal health require a licence or certificate to be granted or an inspection to be made; and
(b)the medicinal product in respect of which an application for a licence or certificate has been made–
(i)is not intended for sale; or
(ii)is intended only for use in the treatment of rare conditions or in the treatment of a minor species of animal or as an emergency vaccine.
For the purposes of sub-paragraph (b)(ii) “emergency vaccine” means (i) no other suitable licensed vaccine is readily available and (ii) the vaccine is manufactured or assembled only from material obtained from the particular animal, flock or herd intended to be vaccinated.
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