The Medicines (Products for Human Use — Fees) Regulations 1995

Explanatory Note

(This note is not part of the Regulations)

These Regulations make provision for the fees payable under the Medicines Act 1971 in respect of marketing authorizations, licences and certificates relating to medicinal products for human use.

Parts II, III and V and Schedules 1 and 2 provide for capital fees to be payable in connection with applications for, or variations to, marketing authorizations, manufacturer’s licences, wholesale dealer’s licences, clinical trial certificates and certificates permitting the export of medicinal products and for associated inspections. Most of these fees were previously provided for by the regulations revoked by these Regulations but there are two exceptions—

(a) a new category of fee is introduced in respect of decentralised incoming applications which are applications for marketing authorizations, in respect of which recognition is sought of any authorization already granted by another member State of the European Community;

(b) Part III of Schedule I imposes a new scheme for the classification of fees for variations to marketing authorizations, based on that set out in Commission Regulation (EC) No. 541/95 (OJ No. L55, 11.3.95, p. 7).

In general the fees prescribed by these Regulations are the same or lower than those which they replace. Two exceptions occur in relation to applications for the variation of marketing authorizations. Here fees of £190 and £342 replace fees of £100 and £235 which have applied to applications for the variation of product licences. However, owing to a revision of the categories of variation many applications which previously would have attracted a fee of £325 will, under these Regulations, attract a fee of £190. Overall it is estimated that the new fee levels will result in a reduction of the yield from fees of about 4%.

Part VI of, and Schedule 3 to, the Regulations impose periodic fees to be payable in connection with the holding of marketing authorizations, manufacturer’s licences and wholesale dealer’s licences. The amount of the periodic fee varies according to the type of product and, in some cases, according to turnover. Excepted from the requirement to pay periodic fees are holders of clinical trial certificates and certain manufacturer’s licences who are required to pay fees on renewal of their certificates or licences (Part IV).

Regulation 23 contains transitional provisions.

Administrative provisions (Part VII, Schedules 4, 5 and 6) deal with time of payment and waiver or refund of both capital and periodic fees in specified circumstances. Special arrangements are provided in respect of the time of payment of capital fees by small companies and a new concession is introduced in respect of small companies who make complex applications for marketing authorizations (Schedule 4).

Part VIII of the Regulations revokes the earlier Regulations relating to fees for medicinal products for human use and also makes saving and transitional provisions.

An assessment of the cost to business of complying with these Regulations has been made, copies of which have been placed in the libraries of both Houses of Parliament and further copies of which may be obtained from the Medicines Control Agency, Department of Health, Room 1207, Market Towers, 1 Nine Elms Lane, London SW8 5NQ.