Explanatory note

These regulations make amendments to the Medicines Act 1968, the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1995 (“the Marketing Authorisations Regulations”), the Medicines (Products for Human Use—Fees) Regulations 1995 (“the General Fees Regulations”) and various other statutory instruments relating to medicinal products.

M1M2M3M4M5M6M7M8M9M10M11The Marketing Authorisations Regulations implemented in part the following provisions of European Community law: Council Directives 65/65/EEC , 75/318/EEC , 75/319/EEC and the Regulations adopted by the Commission under Article 15 of that Directive, 89/342/EEC , 89/343/EEC , 89/381/EEC , 92/26/EEC , 92/27/EEC and 92/73/EEC , now repealed and re-enacted by Directive 2001/83/EC (“the 2001 Directive”), and Council Regulation (EEC) No. 2309/93 and the Regulations adopted by the Commission under Article 15.4 or 22.1 of that Regulation. They provide for the manner of making applications for the grant, renewal or variation of a United Kingdom marketing authorization and for procedures for consideration, revocation, suspension and related matters. Regulation 7 of these Regulations amends the Marketing Authorisations Regulations as a consequence of—

1. (a)

   M12M13Commission Regulations (EC) No. 1084/2003 and No. 1085/2003 , which make provision in relation to variations of marketing authorizations, including the adoption of urgent safety restrictions by competent authorities, and

2. (b)

   M14the adoption of Commission Directive 2003/63/EC , which amends the 2001 Directive by substituting a new Annex I setting out standards and protocols in respect of the testing of medicinal products for which applications for marketing authorization are made.

Regulations 2 to 6 amend the Medicines Act and various statutory instruments, so as to amend references to the 2001 Directive as a consequence of the adoption of Commission Directive 2003/63/EC.

The General Fees Regulations make provision for the fees payable under the Medicines Act 1971 relating to marketing authorizations, licences and certificates in respect of medicinal products for human use and for certain other fees arising out of or relating to Community obligations in relation to such products. Regulations 8, 10 to 12 make changes to the provisions for fees for applications for marketing authorizations, and for variations of such authorizations, as a consequence of the adoption of Commission Regulation (EC) No. 1084/2003 and Commission Directive 2003/63/EC. In particular, regulation 11 makes provision for new fees for minor variations of Type IA and Type IB and for variations to add new indications for use of a product in a different therapeutic area or in respect of a different organ or other part of the human body (“Extended Type II Complex Variation Applications”). Regulation 9 amends regulation 3A of the General Fees Regulations so as to make provision for fees in respect of meetings at which the licensing authority provide scientific advice to potential applicants for variations to marketing authorizations. Regulation 13 amends Schedule 5 of the General Fees Regulations, which relates to refunds and waivers. Regulation 13(2) makes provision for the waiver of fees payable in connection with meetings at which the licensing authority provide scientific advice to potential applicants for marketing authorizations or variations of such authorizations. Regulation 13(3) provides for the waiver of fees for applications for variations of marketing authorizations which result from urgent safety restrictions imposed by the licensing authority.

A Regulatory Impact Assessment in relation to these Regulations has been placed in the libraries of both Houses of Parliament, and copies can be obtained from the Medicines and Healthcare products Regulatory Agency, Room 16-107, Market Towers, 1 Nine Elms Lane, London SW8 5NQ.