The Medicines (Products for Human Use) (Fees) Regulations 2010

Number of fee periods

8.—(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 authorization is granted.

(2) The fee payable in accordance with entry 2(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 authorization is granted.

(3) 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, the fee payable—

(a) for the five relevant fee periods following the fee period during which the marketing authorization is granted is the fee specified at entry 1 of the table set out in paragraph 5, where the first authorization 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 2(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 2(b), (c) or (d) of the table set out in paragraph 5.

(5) In connection with the holding of a marketing authorization in respect of a limited use drug or a derivative of a limited use drug—

(a) where turnover exceeds £200,000, until the expiry of the five relevant fee periods following the fee period during which the marketing authorization 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 turnover 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 authorization was granted, the periodic fee payable is the fee payable in respect of a prescription only medicine in accordance with entry 2(b)(i) of the table set out in paragraph 5.