# The Medicines (Products for Human Use — Fees) Regulations 1995, Paragraph 4: Marketing authorizations


(1) The appropriate fee specified in the Table in paragraph 1 as being that payable in connection with the holding of a marketing authorization relating to a new active substance shall be payable only for the five consecutive relevant fee periods following the fee period during which that marketing authorization was granted, or if the authorization was granted before 18th July 1991,—
(a) where that authorization was granted before 1st April 1991, until and including the relevant fee period during which falls the fifth anniversary of the granting of the authorization; and
(b) where that authorization was granted on or after 1st April 1991, until and including the relevant fee period during which falls the fourth anniversary of the granting of the authorization.
(2) Subject to sub-paragraphs (3) and (5), the appropriate periodic fee in respect of a derivative of a new active substance shall be payable for the five relevant fee periods following the fee period during which the marketing authorization relating to the new active substance upon which the application was based, was first granted, or if the authorization was granted before 18th July 1991,—
(a) where that authorization was granted before 1st April 1991, until and including the relevant fee period during which falls the fifth anniversary of the granting of the authorization; and
(b) where that authorization was granted on or after 1st April 1991, until and including the relevant fee period during which falls the fourth anniversary of the granting of the authorization.
(3) The fee payable in accordance with entry 2(a) of the Table set out in paragraph 1 shall only be payable for the three relevant fee periods following the year beginning 1st April during which the marketing authorization was granted.
(4) Where a marketing authorization is surrendered and at the same time another marketing authorization held by the authorization holder is varied so as to include in that other authorization the provisions of the first authorization—
(a) where the first authorization relates to a new active substance, the fee payable shall, for each fee period mentioned in sub-paragraph (1), be that specified at entry 1 of the Table set out in paragraph 1;
(b) in all other cases, the fee payable shall, for each fee period mentioned in sub-paragraph (3), be that specified at entry 2(a) of that Table.
(5) In respect of fee periods following those referred to in sub-paragraphs (1), (2) and (3) of this paragraph the periodic fees shall be the appropriate fees for the kind of medicinal product in question specified in entries 2(b), (c) or (d) of the Table set out in paragraph 1.
(6) In connection with the holding of a marketing authorization in respect of a limited use drug or a derivative of a limited use drug the periodic fee shall be—
(a) 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 entry 2(b)(i) of the Table set out in paragraph 1.

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Source: https://www.legislation.gov.uk/uksi/1995/1116/schedule/3/paragraph/4 (the official version)
Page: https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1995/schedule-3/paragraph-4
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.