# The Medicines (Products for Human Use) (Fees) Regulations 2016, Paragraph 8: Number of fee periods


(1) The fee specified in—
(a) paragraph 5 for a new active substance; and
(b) in paragraph 7 for a derivative of a new active substance,
is only payable for the five relevant fee periods following that in which the marketing authorisation is granted.
(2) The fee payable in accordance with entry 3(a) of the table set out in paragraph 5 is only payable for the three relevant fee periods following the year beginning 1st April during which the marketing authorisation is granted.
(3) Where a marketing authorisation is surrendered and at the same time another marketing authorisation held by the authorisation holder is varied so as to include in that other authorisation the provisions of the first authorisation, the fee payable—
(a) for the five relevant fee periods following the fee period during which the marketing authorisation is granted is the fee specified at entry 1 of the table set out in paragraph 5, where the first authorisation relates to a new active substance;
(b) in all other cases, for each fee period mentioned in sub-paragraph (2), is the fee specified at entry 3(a) of that table.
(4) In respect of fee periods following those referred to in sub-paragraphs (1) to (3) of this paragraph, the periodic fees are the appropriate fees for the kind of medicinal product in question specified in entries 3(b), (c) or (d) of the table set out in paragraph 5.
(5) In connection with the holding of a marketing authorisation in respect of a limited use drug or a derivative of a limited use drug—
(a) where the total value of the product sold or supplied exceeds £200,000, until the expiry of the five relevant fee periods following the fee period during which the marketing authorisation was granted, the periodic fee payable is the fee that would be payable if the drug were, respectively, a new active substance or a derivative of a new active substance;
(b) where the total value of the product sold or supplied does not exceed £200,000 or where a periodic fee has been payable in respect of the limited use drug or derivative of a limited use drug for five relevant fee periods following the fee period during which the marketing authorisation was granted, the periodic fee payable is the fee payable in respect of a prescription only medicine in accordance with entry 3(b)(i) of the table set out in paragraph 5.

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Source: https://www.legislation.gov.uk/uksi/2016/190/schedule/4/paragraph/8 (the official version)
Page: https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-4/paragraph-8
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.