The Medicines for Human Use (Clinical Trials Fees Amendments) Regulations 2004

Explanatory Note

(This note is not part of the Regulations)

These Regulations make further amendments to the Medicines (Products for Human Use—Fees) Regulations 1995 (“the General Fees Regulations”). The General Fees Regulations make provision for the fees payable in relation to marketing authorizations, licences and certificates in respect of medicinal products for human use. These Regulations amend the General Fees Regulations to provide for fees in respect of authorisations and inspections relating to clinical trials of such products.

Regulation 2 amends regulation 2 of the General Fees Regulations (interpretation).

Regulations 3, 4, 8, 9, 12 and 13 amend the General Fees Regulations to make provision for capital fees for: requests for authorisations of clinical trials given by the licensing authority under the Medicines for Human Use (Clinical Trials) Regulations 2004 (“clinical trial authorisations”); certain notices of amendment of such authorisations; applications for authorisation to manufacture medicinal products for a clinical trial, granted by the licensing authority under those Regulations (“manufacturing authorisations”); and applications for the variation of such authorisations.

Regulations 6 and 10 amend the General Fees Regulations to make provision for fees for inspections relating to manufacturing sites connected with manufacturing authorisations or clinical trial authorisations, and for inspections of sites for the purposes of ascertaining whether clinical trials are being conducted in accordance with the conditions and principles of good clinical practice.

Regulations 7 and 11 amend the General Fees Regulations to make provision for periodic fees for manufacturing authorisations and clinical trial authorisations.

Regulations 3 to 5, 8, 9 and 13 also make consequential amendments to remove references to fees relating to clinical trial certificates issued under section 31 of the Medicines Act 1968; that provision is repealed by the Medicines for Human Use (Clinical Trials) Regulations 2004.

A full regulatory impact assessment of the effect that this instrument will have on the costs of business is available from the Medicines and Healthcare products Regulatory Agency, Room 10-202, Market Towers, 1 Nine Elms Lane, London SW8 5NQ and a copy has been placed in the libraries of both Houses of Parliament.