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,

X1Having regard to the European Parliament1,

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 Products2, 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 products3 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 products4 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 interest of its holder;

Whereas the market for a veterinary medicinal product differs from that of a medicinal product for human use and therefore justifies a general reduction of the fee; whereas it should furthermore be possible to take account of the particular situation linked to the marketing of certain veterinary medicinal products on an individual basis; whereas this aim can best be achieved by means of special provisions such as a clause for reductions and waivers;

Whereas, as regards the evaluation of applications to establish maximum residue limits (MRLs), it is up to the applicant to decide whether to apply separately for the establishment of MRLs or to do so together with his application for a Community marketing authorization in which case the fee incurred for the evaluation of the application for authorization should cover the one for the establishment of MRLs; whereas, however, if the applicant deliberately chooses to apply separately for the establishment of MRLs, the additional work and expenditure should be recouped by means of an isolated MRL fee;

Whereas all other fees for the evaluation of veterinary medicinal products should follow the principles described above;

Whereas provision should be made for waivers or reductions of the fees stated above under exceptional circumstances for essential public health or animal health reasons; whereas any decision upon those cases should be taken by the Director after hearing the competent committee and on the basis of general criteria laid down by the Agency's Management Board;

Whereas a provisional period of three years should be laid down after which the experience gained will enable the financial needs of the Agency to be re-assessed; whereas for practical reasons provision should also be made for machinery to permit rates to be updated over shorter periods;

Whereas the Treaty does not provide the necessary powers for fixing fees at Community level, within the framework of a Community system; whereas it is therefore appropriate to have recourse to Article 235 of the Treaty,

HAS ADOPTED THIS REGULATION: