Explanatory note

These Regulations amend the Medicines (Products for Human Use– Fees) Regulations 1991 which prescribe fees in connection with applications and inspections relating to licences and certificates granted under the Medicines Act 1968 and also prescribe periodic fees in connection with the holding of such licences, insofar as they apply to medicinal products for human use only.

These Regulations (regulation 2 and the Schedule) increase (with a few minor exceptions where the fees have remained the same) the fees payable for applications for the grant of product licences, manufacturers' licences, wholesale dealers' licences, clinical trial certificates and export certificates, for variations of such licences or certificates, for the renewal of certain manufacturers' licences and clinical trial certificates and periodic fees in connection with the holding of licences. They also increase the fees payable in respect of inspections of sites carried out in connection with applications for, or during the currency of, such licences. The new fees represent an overall average increase of 5.5%.

These Regulations also provide for special fees to be payable in connection with applications for renewal of certain product licences. This provision is made in connection with the implementation of Council Directives–

89/342/EEC relating to immunological products (OJ No. L142, 25.5.1989, p.14);

89/343/EEC relating to radiopharmaceuticals (OJ No. L142 25.5.1989, p.16); and

89/381/EEC relating to medicinal products derived from human blood or human plasma (OJ No. L181, 28.6.1989, p.44).

These Directives extend the scope of Council Directives 65/65/EEC (OJ No. 22, 9.2.1965, p.369/65) and 75/319/EEC (OJ No. L147, 9.6.1975, p.13) on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products to cover such products which had previously been excluded by Article 34 of Council Directive 75/319/EEC (regulations 3(2), 4 and 5).

Three scales of fees are provided for in connection with these applications. The lowest scale relates to applications accompanying other applications which are for different strengths of a medicinal product and where no medical, scientific or pharmaceutical assessment is required. The next scale applies where the application for the original product licence was accompanied by an Expert’s Report and a Summary of Product Characteristics. The regulations provide for the higher fees to be payable in all other cases and provide that these may be payable in two instalments over six months (regulation 7). Small companies are given an extra six months in which to pay these higher fees (regulation 11).

These Regulations also provide for a lower rate of fee to be payable in respect of applications for product licences which may be made in circumstances where a product licence already exists in respect of a medicinal product and an application is made by a different person in identical terms to that relating to the existing product licence (regulations 3(2)(b), 8(2)(c) and (3)), and make special provision for periodic fees for the first licence fee period of the new licence (regulation 6(4)).

It is also provided that where the licensing authority receives a request to cancel a licence not less than three months before the commencement of a licence fee period, for the purpose of periodic fees, that licence shall not be considered to be in force at the beginning of that period (regulation 6(2) and (5)).

These Regulations also make other minor amendments relating to, interpretation provisions (regulations 3(3) and 6(3)), complex applications for product licences (regulation 8(2)(a) and (b)), certain surgical materials (regulation 8(4)), inspections of sites where only sterilisation of products manufactured elsewhere takes place (regulation 9(2)), inspections of especially large sites (regulation 9(3)), homoeopathic and anthroposophic products (regulation 10(2) and (4)), and the payment of periodic fees for new active substances or derivatives of new active substances (regulation 10(3)).