Regulation 1995/297 - Fees payable to the European Agency for the Evaluation of Medicinal Products - Main contents

official title

 

Legal instrument	Regulation
Number legal act	Regulation 1995/297
Original proposal	COM(1994)167
CELEX number i	31995R0297

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Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products

Official Journal L 035 , 15/02/1995 P. 0001 - 0005

COUNCIL REGULATION (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, in particular Article 235 thereof,

Having regard to the proposal from the Commission,

Whereas Article 58 of Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products (1), hereinafter referred to as 'the Agency`, requires the Council to establish the structure and the amount of fees referred to in Article 57 (1);

Whereas Article 57 (1) of the Regulation establishes that the revenues of the Agency shall consist of a contribution from the Community, and the fees paid by undertakings for obtaining and maintaining a Community marketing authorization and for other services provided by the Agency;

Whereas Articles 6 (3) and 28 (3) respectively of Regulation (EEC) No 2309/93 require that any application for authorization for a medicinal product or any application for a variation be accompanied by the fee payable to the Agency for the examination of the application;

Whereas the calculation of the amount of the fees charged by the Agency must be based on the principle of the service actually provided;

Whereas the amount of the fees laid down in this Regulation should not be a determining factor for the applicant for an authorization where there is a choice between a centralized procedure and a national procedure;

Whereas the basic fee should be defined as the fee charged for the initial application for an authorization for a medicinal product plus a fee for each different strength and/or pharmaceutical form; whereas, however, a ceiling should be established;

Whereas to the same end, an extension fee should be laid down for subsequent applications regarding a medicinal product which has already been authorized in order to take account of the additional work and expenditure where an applicant chooses to submit the applications gradually and subsequently;

Whereas provision should be made for a reduced fee for applications which may be sustained by a less detailed dossier pursuant to point 8 of the second paragraph of Article 4 of Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products (2) and point 8 of the second paragraph of Article 5 of Council Directive 81/851/EEC of 28 September 1981 on approximation of the laws of the Member States relating analytical, pharmaco-toxicological and clinical standards protocols in respect of the testing of veterinary medicinal products (3) respectively and for applications concerning a medicinal product for use in non-food producing animals;

Whereas the examination of variations to the terms of existing authorizations not requiring full evaluation of the product's quality, safety and efficacy should be charged according to the complexity of the variations and the real workload linked to them, and therefore at a rate far lower than for a standard application;

Whereas the work involved in the mandatory five-yearly renewal of a Community marketing authorization justified the charging of a fee;

Whereas a fee should be laid down for arbitration services in the event of disagreement between Member States on applications for authorizations submitted under the decentralized procedure;

Whereas a fee should be levied on a flat-rate basis for any inspection made successively to a marketing authorization at the request or in the...

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