Proposal for a Council Regulation (EC) on fees payable to the European Medicines Evaluation Agency (94/C 398/08) COM(94) 167 final

(Submitted by the Commission on 27 May 1994)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community,

Having regard to Council Regulation (EEC) No 2309/93 of 22 July 1993 lying 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, and in particular Article 58 thereof,

Having regard to the proposal from the Commission,

Whereas Article 58 of the Regulation 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 European Agency for the Evaluation of Medicinal Products (hereinafter referred to as 'the Agency`) shall consist of a contribution of 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) of the Regulation respectively require an application for authorization for a medicinal product to be accompanied by the fee payable to the Agency for the examination of the application;

Whereas the standard fee should be defined as the comprehensive full fee covering all applications for the different strengths, schedules of dosage, routes and forms of administration which are made simultaneously for a given medicinal product in the initial request in order to facilitate the collection of all necessary data at one time and, by that means, streamline the authorization procedure and make it most cost-effective;

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 it should be provided for a reduced fee for applications not required to be sustained by a full dossier pursuant to Article 4 of Directive 65/65/EEC and Article 5 of Directive 81/851/EEC respectively and for applications concerning a medicinal product for use in non-food producing animals;

Whereas variations, either administrative or other, to the terms of existing authorizations not requiring full assessment of the product's quality, safety and efficacy should be charged according to their complexity and the real workload linked to them and therefore far less than a standard application;

Whereas the work involved in the mandatory five yearly renewal of a Community marketing authorization justifies a corresponding fee at the level of a fee for a complex variation;

Whereas fees for arbitrations under the decentralized procedure should be fixed on the principle of service effectively rendered by the Agency; whereas that work can be assessed at more or less the same level as that involved in a variation requiring a complex evaluation; whereas furthermore the arbitration procedure arises from differences between Member States about the mutual recognition of marketing authorizations and is hence independent of the applicant's attitude; whereas, therefore, the levying of an arbitration fee by the Agency should be compensated by a reduction by one half of national fees of all Member States other than the first one where an application has been successfully lodged;

Whereas on the same grounds of service effectively rendered 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 nature of assessment of a veterinary medicinal product as well as the size of the market involved are substantially different from those of a medicinal product for human use and do therefore justify 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 be best achieved under the special provisions of a clause for reductions and waivers;

Whereas as regards the evaluation of applications for 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, 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, as regards all other fees for the assessment of veterinary medicinal products, the reasons for levying them or to abstain from it remain identical to those stated above;

Whereas it should be provided for waivers or reductions of the fees stated above under exceptional circumstances as for example in the case of medicinal products designed to treat only a limited number of patients of a particular disease (so-called orphan drugs), small-sized businesses or for essential public health reasons; whereas it should be decided upon those cases only on the merits of each individual case by the management board; whereas to that effect, a proposal from the Director has to be made after hearing the competent Committee,

HAS ADOPTED THIS REGULATION:

Article 1

Scope

1. Fees for obtaining and maintaining a Community marketing authorization shall be levied in accordance with this Regulation.

2. They shall be laid down in ecus.

Article 2

Applications for medicinal products for human use under the centralized procedure

1. Full fee (200 000)

It is the comprehensive standard fee for an application for a Community marketing authorization of a given medicinal product sustained by a full dossier. It covers all applications for the different strengths, schedules of dosage, routes and forms of administration which are made simultaneously for that medicinal product at the time of the initial application.

2. Reduced fee (100 000)

It is the reduced fee for an application for a Community marketing authorization of a given medicinal product not required to be sustained by a full dossier as provided for under the exception rules of point 8 (a) of the second paragraph of Article 4 of Directive 65/65/EEC. It covers all applications for the different strengths, schedules of dosage, routes and forms of administration which are made simultaneously for that medicinal product at the time of the initial application.

3. Extension fee (40 000)

It is the fee for each supplement or extension of an existing Community marketing authorization of a given medicinal product to different strengths, schedules of dosage, routes and forms of administration. It applies where an applicant chooses to submit the applications gradually and subsequently to take account of the additional work and expenditure hereby caused.

4. Variation fee type I (5 000)

It is the fee for an administrative or minor change to an existing marketing authorization which would be proposed by the marketing authorization holder and would neither change the specifications for the active ingredient(s), the release specifications or end of shelf-life-specifications as already authorized nor alter the summary of product characteristics or the labelling of the medicinal product.

5. Variation fee type II (40 000)

It is the fee for all other changes proposed by the marketing authorization holder to the particulars referred to in Article 4 of Directive 65/65/EEC of an existing authorization not requiring a new application.

6. Five-yearly renewal fee (40 000)

It is the fee due for the obligatory five-yearly renewal of a Community marketing authorization after a review of the available new information about the product.

7. Inspection fee (10 000)

It is the flat-rate fee for any inspection within the European Communities made at the request or in the interest of the holder of a marketing authorization. For inspections outside the European Communities travel expenses will be charged extra on the basis of the effective cost.

Article 3

Applications for medicinal products for human use under the decentralized procedure

Arbitration fee (40 000)

It is the flat rate fee for the work of the Agency involved in the arbitration of disagreements between Member States on the mutual recognition of a national marketing authorization in the decentralized procedure.

Member States fees for delivering a national marketing authorization are reduced by one half except for the first Member State that issued a marketing authorization for that medicinal product.

Article 4

Applications for medicinal products for veterinary use under the centralized procedure

1. Full fee (100 000)

It is the comprehensive standard fee for an application for a Community marketing authorization of a given medicinal product for use in food producing animals sustained by a full dossier. It covers all applications for the different species, strengths, schedules of dosage, routes and forms of administration and for the establishment of an MRL which are made simultaneously for that medicinal product at the time of the initial application.

2. Reduced fee (50 000)

It is the reduced fee for an application for a Community marketing authorization of a given medicinal product not required to be sustained by a full dossier as provided for under the exception rules of point 10 (a) of the second paragraph of Article 5 of Directive 81/851/EEC or for an application concerning a medicinal product for use in non-food producing animals. It covers all applications for the different species, strengths, schedules of dosage, routes and forms of administration which are made simultaneously for that medicinal product at the time of the initial application.

3. Isolated MRL fee (50 000)

It is the fee for an isolated establishment of an MRL for a new medicinal product.

4. Extension fee (20 000)

It is the fee for each supplement or extension of an existing Community marketing authorization of a given medicinal product to different species, strengths, schedules of dosage, routes and forms of administration. It applies where an applicant chooses to submit the applications gradually and subsequently to take account of the additional work and expenditure hereby caused.

5. Variation fee type I (5 000)

It is the fee for an administrative or minor change to an existing marketing authorization which would be proposed by the marketing authorization holder and would neither change the specifications for the active ingredient(s), the release specifications or end of shelf-life-specifications as already authorized nor alter the summary of product characteristics or the labelling of the medicinal product.

6. Variation fee type II (20 000)

It is the fee for all other changes proposed by the marketing authorization holder to the particulars referred to in Article 5 of Directive 81/851/EEC of an existing authorization not requiring a new application.

7. Five-yearly renewal fee (20 000)

It is the fee due for the obligatory five-yearly renewal of a Community marketing authorization after a review of the available new information about the product.

8. Inspection fee (10 000)

It is the flat-rate fee for any inspection within the European Communities made at the request or in the interest of the holder of a marketing authorization. For inspections outside the European Communities travel expenses will be charged extra on the basis of the effective cost.

Article 5

Applications for medicinal products for veterinary use under the decentralized procedure

Arbitration fee (20 000)

It is the flat rate fee for the work of the Agency involved in the arbitration of disagreements between Member States on the mutual recognition of a national marketing authorization in the decentralized procedure.

Member States fees for delivering a national marketing authorization are reduced by one half except for the first Member State that issued a marketing authorization for that medicinal product.

Article 6

Waivers, fee reductions and dispute settlement

1. Under exceptional circumstances, as for example in the case of medicinal products designed to treat only a limited number of patients of a particular disease (so-called orphan drugs), small sized businesses or for essential public health reasons, the management board may decide upon waivers and fee reductions on the merits of each individual case on a proposal from the Director who will have consulted the competent committee.

2. The same procedure shall apply to any disagreement which may arise about the classification of an application under one of the above fee items.

Article 7

Due date and belated payment

1. Fees in respect of which the due is not specified in this Regulation (EEC) No 2309/93 shall be due on the date of receipt of the application for the service for which the fee is incurred.

2. Where any fee payable under this Regulation remains unpaid at its due date the Director may decide not to make or to suspend services dependent upon the advance payment of the corresponding fee.

Article 8

Implementing rules

1. Without prejudice to other provisions of this Regulation or Regulation (EEC) No 2309/93, implementing rules to be adopted by the Agency's management board shall lay down the due date for fees to be paid pursuant to Article 1, the methods of their payment, the consequences of belated or omitted payment and contain all other provisions needed to put the present Regulation into effect.

2. The same rules shall determine the conversion rates in national currencies of the fees and costs to be levied under this Regulation and laid down pursuant to Article 1 (2) in ecus.

Article 9

Conversion of procedures

Former concertation procedures converted on 1 January 1995 to centralized procedures pursuant to Article 2 of Directive 93/41/EEC attract the arbitration fee as laid down in Articles 3 and 5.

Article 10

Entry into force and legal effect

1. This Regulation shall enter into force on the day following its publication in the Official Journal of the European Communities.

2. It shall be binding in its entirety and directly applicable in all Member States.