# The Medicines (Products for Human Use — Fees) Regulations 1991, Paragraph 4: Product licences


(1) The appropriate fee specified in the Table in paragraph 1 as being that payable in connection with the holding of a product licence relating to a new active substance shall be payable only for the five relevant licence fee periods following the licence fee period during which that licence was granted, or if the licence was granted before these Regulations came into force, until and including the relevant licence fee period during which falls the fifth anniversary of the date of granting of the licence.
(2) Subject to sub-paragraphs (3) and (5) below, the appropriate periodic fee in respect of a derivative of a new active substance shall be payable for the five relevant licence fee periods following the licence fee period during which the product licence relating to the new active substance upon which the application was based, was first granted, or if the licence was granted before these Regulations came into force, until and including the relevant licence fee period during which falls the fifth anniversary of the date of granting of the licence.
(3) The fee payable in accordance with entry 2(a) of the Table set out in paragraph 1 shall be payable only for the three relevant licence fee periods following the year beginning 1st April during which the product licence was granted.
(4) Where a licence in respect of which a fee is payable in accordance with entry 2(a) of the Table in paragraph 1 is surrendered and at the same time another licence held by the licence holder is varied so as to include in that other licence the provisions of the first licence, then the fee payable in respect of that other licence shall, fo rthe period mentioned in paragraph 3, be that specified at entry 2(a) of that Table instead of any other fee.
(5) In respect of licence fee periods following those referred to in sub-paragraphs (1), (2) and (3) of this paragraph, periodic fees shall be payable in accordance with entries 2(b), (c) or (d) of the Table set out in paragraph 1.
(6) In connection with the holding of a product licence in respect of a limited use drug or a derivative of a limited use drug the periodic fee shall be–
(a) subject to paragraph 4(1) where turnover exceeds £200,000, that which would be payable if the drug were, respectively, a new active substance or a derivative of a new active substance;
(b) where turnover does not exceed £200,000, that payable in respect of a prescription only medicine in accordance with the Table set out in paragraph 1.

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Source: https://www.legislation.gov.uk/uksi/1991/1474/schedule/3/paragraph/4 (the official version)
Page: https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1991/schedule-3/paragraph-4
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.