Explanatory note

These Regulations amend the Medicines (Fees Relating to Medicinal Products for Human Use) Regulations 1989 which prescribe fees in connection with applications and inspections relating to licences and certificates granted under the Medicines Act 1968 so far as they apply to medicinal products for human use only and insert a transitional provision in respect of applications made by specified health authorities (regulation 8).

These regulations (regulation 2 and the Schedule) vary the fees payable for applications for the grant of product licences, manufacturers' licences, clinical trial certificates and export certificates, for variations of such licences or certificates and for their renewal. They also increase some of the fees payable in respect of inspections of sites carried out in connection with applications for, or during the currency of, such licences or certificates.

The regulations revoke the exemption from paying fees in respect of health authorities constituted for any part of the United Kingdom (regulation 3).

These regulations make various other amendments as follows:—

• they insert a definition of qualified person (regulation 4) and widen the categories of variations of licences for which a reduced fee is payable (regulation 5);

• they add a new category of inspection for the purpose of calculating fees (regulation 6);

• they extend the provisions on waiver of fees (regulation 7).