Explanatory note

These Regulations make provision for the fees which are to be payable under the Medicines Act 1971 in respect of licences and certificates relating to medicinal products for human use granted under the Medicines Act 1968.

Parts II, III and V and Schedules 1 and 2 provide for capital fees to be payable in respect of applications for, or variations to, product licences, manufacturers' licences, wholesale dealers' licences, clinical trial certificates and certificates permitting the export of medicinal products, and for associated inspections. All of these fees were provided for by the regulations revoked by these Regulations; the level of the fees has in most cases been reduced, but some remain unchanged and one has been increased.

Part VI of, and Schedule 3 to, the Regulations introduce a new fee, to be known as a periodic fee, which is payable in connection with the holding of product licences, manufacturers' licences and wholesale dealers' licences. The amount of the fee varies according to the type of product and, in some cases according to turnover. Fees which were previously payable in connection with renewals of licences have, with certain exceptions, been abolished. The exceptions are clinical trial certificates and certain manufacturers' licences (Part IV). Partial abatement of periodic fees has been provided for in respect of those applicants who have paid renewal fees since April 1989 (Schedule 6).

It is estimated that the changes made in the fee structure will result in a reduction of the yield from capital fees of about 35% so that in future those fees will provide about 60% of fee income, the other 40% being provided by periodic fees.

Regulation 23 contains transitional provisions. In particular it provides that any fee which was payable in respect of an application for the renewal of a licence which was due to expire after the date when these Regulations came into force but made before that date, shall be refunded or waived.

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 (Schedule 4).

Part VIII of the Regulations revokes the existing regulations relating to fees for medicinal products for human use.