The Medicines (Products for Human Use) (Fees) Regulations 2016

1.  In this Schedule— U.K.

“anthroposophic product” means a medicinal product prepared in accordance with the methods of anthroposophic medicine which is sold or supplied as an anthroposophic product and is so described by the person who sells or supplies that medicinal product;

“derivative”, in relation to a limited use drug or a new active substance, means a medicinal product—

(a)

which contains the same active ingredient or combination of active ingredients as that drug or substance but which is either—

(i)

a different dosage form of that drug or substance; or

(ii)

of the same dosage form as, but of a different strength of active ingredient to, or of a different combination of active ingredients to, that drug or substance; and

(b)

in respect of which an application for a marketing authorisation was made before the determination of the application for the marketing authorisation for that drug or substance;

“general sale list medicine” means a medicinal product (not being an anthroposophic product, a herbal remedy or a homoeopathic medicinal product) classified as subject to general sale within the meaning of regulation 5(1) of the Human Medicines Regulations;

“limited use drug” means a medicinal product in respect of which an application for a marketing authorisation has been submitted, to which point 6 of Part II of Annex I to the 2001 Directive applies or [F1 in respect of which an orphan marketing authorisation has been granted];

“lower fee” means the periodic fee payable—

(a)

where the medicinal product has not been manufactured or imported into the United Kingdom during the period of 12 months preceding the commencement of the relevant fee period; or

(b)

in relation to a medicinal product that has been manufactured or imported into the United Kingdom during the period referred to in (a) above, where the value of the product sold or supplied during that period did not exceed £1,000; and

(c)

in relation to a prescription only product, where the authorisation holder has notified the licensing authority that the medicinal product to which the marketing authorisation relates, is not expected to be manufactured, or imported into the United Kingdom during the relevant fee period; or

(d)

in relation to a pharmacy medicine or a general sale list medicine, the periodic fee payable during the relevant fee period;

“new active substance” means a medicinal product which is not a limited use drug and which contains an active ingredient which has not previously been included as an active ingredient in a medicinal product in respect of which a marketing authorisation (other than a product licence of right) has been granted in the five years preceding 31st December in the fee period preceding the relevant fee period;

“pharmacy medicine” means a medicinal product (not being an anthroposophic product, a herbal remedy or a homoeopathic medicinal product) classified as a pharmacy medicine within the meaning of regulation 5(5) of the Human Medicines Regulations;

“prescription only medicine” means a medicinal product (not being an anthroposophic product, a herbal remedy, a homoeopathic medicinal product, a new active substance or a derivative of a new active substance) classified as a prescription only medicine within the meaning of regulation 5(3) of the Human Medicines Regulations;

“reduced rate fee” means the periodic fee payable in relation to a prescription only medicine where the total value of the product which is sold or supplied in the relevant fee period does not exceed £35,000;

“standard fee” means the periodic fee payable in relation to a prescription only medicine where the total value of the product which is sold or supplied in the relevant fee period exceeds £35,000; and

“total value of the product” means the amount calculated in accordance with Part 2 of this Schedule.

Textual Amendments

F1 Words in Sch. 4 para. 1 substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 1 para. 8 (with Sch. 1 para. 11); 2020 c. 1, Sch. 5 para. 1(1)