The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2002

Explanatory Note

(This note is not part of the Regulations)

These Regulations make further amendments to the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 (“the Homoeopathic Products Regulations”), the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 (“the Marketing Authorisations Regulations”), the Medical Devices (Consultation Requirements) (Fees) Regulations 1995 (“the Devices Regulations”) and the Medicines (Products for Human Use-Fees) Regulations 1995 (“the General Fees Regulations”).

M1 M2 The Homoeopathic Products Regulations implemented in part Council Directive 92/73/EEC (now repealed and re-enacted in Directive 2001/83/EC ) by introducing a new registration procedure for the marketing of certain homoeopathic medicinal products for human use. Regulation 2 of these Regulations amend the Homoeopathic Products Regulations. Regulation 2(1) and (2) amends regulations 6 and 9 of those Regulations to remove the requirement that decisions to grant, suspend and revoke a certificate of registration must be published in the Gazette. Regulation 2(3) increases the amounts of the fees payable for variations of certificates of registration, regulation 2(4) increases the fee payable by holders of certificates of registration and regulation 2(5) increases the amounts of the capital fees payable for applications for certificates of registration. These increases average overall 9.5%.

M3 M4 M5 M6 M7 M8 M9 M10 M11 M12 M13 The 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under Article 15 of that Directive, 89/342/EEC , 89/343/EEC , 89/381/EEC , 92/26/EEC , 92/27/EEC and 92/73/EEC , now repealed and re-enacted by Directive 2001/83/EC , and Council Regulation (EEC) No. 2309/93 and the Regulations adopted by the Commission under Articles 15.4 or 22.1 of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 3 of these Regulations amends the Marketing Authorisations Regulations. Regulation 3(2) and (4) amends regulations 5 and 6 of those Regulations so as to remove the requirement that decisions to grant, revoke, suspend or vary a marketing authorization must be published in the Gazette. Regulation 3(3) inserts new regulation 5A into those Regulations (which relates to the provisions of Directive 92/26/EC, re-enacted as Title VI in Directive 2001/83/EC), so as to provide that the classification of a medicinal product is a condition of the marketing authorization relating to that product, and regulation 3(5) and (6) makes consequential amendments.

M14 The Devices Regulations prescribe the fees which are payable where a notified body consults the competent body in accordance with Council Directive 93/42/EEC concerning medical devices. Regulation 4 of these Regulations amends the Devices Regulations by increasing the amounts of the fees specified in regulation 3 of those Regulations by an average overall of 12.5%.

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. Regulation 5 of these Regulations amend those Regulations as follows. Regulation 5(3) and (7) inserts new Part IVA into the General Fees Regulations, and a new Part IV into Schedule 1 to those Regulations. These contain provisions relating to the setting of new capital fees in cases where the United Kingdom provides assistance to another EEA state arising out of an application for the renewal of a United Kingdom marketing authorization relating to a medicinal product that has been subject to certain procedures for the mutual recognition and harmonisation of marketing authorizations within the Community. Regulation 5(2) makes an amendment consequential on these provisions. Regulation 5(4) amends Part I of Schedule 1 to those Regulations so as to provide that where an application for the grant of a marketing authorization names a manufacturer of the active ingredient of the medicinal product in question different from the manufacturer of that ingredient in a product in respect of which a marketing authorization has previously been granted, the application is not a complex application if a European Pharmacopoeia certificate of suitability covering the active ingredient has been submitted with the application. Regulation 5(5) and (6) amends Parts II and III of Schedule 1 to those Regulations so as to provide that an additional fee is payable where an application for the grant of a marketing authorization, or for the variation of a marketing authorization, changes whether a medicinal product is available only on prescription, only from a pharmacy or on general sale, or provides that the basis on which it is to be made available is different from that of certain similar products. Regulation 5(8) makes an amendment so as to provide that the additional fee may be reduced in certain cases.

There is also a package of changes to the General Fees Regulations relating to the levels of capital fees payable for applications for marketing authorizations, manufacturers’ licences, wholesale dealers’ licences, clinical trial certificates and export certificates; capital fees payable for variations and renewals of such authorizations, licences and certificates; periodic fees payable in connection with the holding of certain authorizations and licences; and the fees payable in connection with site inspections (regulation 5(9) and the Schedule to these Regulations). Fees have been increased by approximately 8%.

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 Control Agency, Room 16-106, Market Towers, 1 Nine Elms Lane, London SW8 5NQ.