Proposal for a Council Regulation (EC) amending Council Regulation (EC) No 297/95 on fees payable to the European Agency for the Evaluation of Medicinal Products (1999/C 22/06) COM(1998) 21 final

(Submitted by the Commission on 22 January 1998)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community,

Having regard to Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products (1) (hereinafter referred to as 'the Agency`), and in particular Article 10 thereof,

Having regard to the proposal from the Commission,

Whereas under Article 57(1) of Council Regulation No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products (2), the revenues of the Agency consist of a contribution and the fees paid by undertakings for obtaining and maintaining a Community marketing authorisation and for other services provided by the Agency;

Whereas the amounts and structure of the fees established by Regulation (EC) No 297/95 must be reviewed before 31 December 1997;

Whereas in view of the experience gained since 1995 it is appropriate to maintain the general principles and overall structure of the fees as well as the main operational and procedural provisions established by the abovementioned Regulation;

Whereas for certain fees, however, the services they relate to should be specified so as to facilitate their collection and improve the transparency and practical implementation of this Regulation;

Whereas new fees must also be established to cover all the services now provided by the Agency;

Whereas an annual fee must be introduced to ensure coverage of the costs connected with the supervision of authorised medicinal products; whereas a given part of this fee will have to go to the competent national authorities required under the terms of Regulation (EEC) No 2309/93 to supervise the market on behalf of the Community; whereas, moreover, the rules for distribution among those authorities will have to be adopted by the Agency's Management Board in accordance with the procedure laid down in this Regulation;

Whereas, in certain exceptional cases and for imperative reasons of public or animal health, it must be possible to reduce the abovementioned fees; whereas, therefore, without prejudice to more specific provisions of Community law, any decision to reduce fees will have to be taken by the Executive Director on the basis of a critical examination of the situation specific to each case after consultation of the competent scientific committee,

HAS ADOPTED THIS REGULATION:

Article 1

Regulation (EC) No 297/95 is hereby amended as follows:

1. Article 1 is replaced by the following text:

'Article 1

Scope

Fees for obtaining and maintaining a Community authorisation to market medicinal products for human and veterinary use and for the other services supplied by the Agency shall be levied in accordance with this Regulation.

The amounts of these fees shall be laid down in ecus.`

2. Articles 3 to 11 are replaced by the following text:

'Article 3

Medicinal products for human use covered by the procedures laid down in Council Regulation (EEC) No 2309/93

(1) Authorisation to market a medicinal product

(a) Full fee

The fee for an application for authorisation to market a medicinal product supported by a full dossier is ECU 200 000. It covers only one presentation of the medicinal product (for one strength associated with one pharmaceutical form).

The fee shall be increased by ECU 20 000 for each additional strength and/or pharmaceutical form submitted at the same time as the initial application for authorisation. This increase covers only one presentation of the additional strength and/or pharmaceutical form.

The fee shall be increased by ECU 5 000 for each additional presentation of the same strength and pharmaceutical form, submitted at the same time as the initial application for authorisation.

(b) Reduced fee

A reduced fee of ECU 100 000 shall apply to applications for authorisation to market a medicinal product for which a full dossier need not be presented, as provided for in Article 4 point 8(a)(i) and (iii) of Directive 65/65/EEC or when recourse is had to Article 4 point 8(a)(ii) of the same Directive. This fee covers a single presentation (for one strength associated with one pharmaceutical form).

The fee shall be increased by ECU 20 000 for each additional strength and/or pharmaceutical form submitted at the same time as the initial application for authorisation. This increase covers only one presentation of the additional strength and/or pharmaceutical form.

The fee shall be increased by ECU 5 000 for each additional presentation of the same strength and pharmaceutical form, submitted at the same time as the initial application for authorisation.

(c) Extension fee

This is the fee for each extension of a marketing authorisation which has already been granted:

- where the extension is for a new strength, a new pharmaceutical form or a new indication, the fee is ECU 50 000;

- where the extension is for a new presentation of a strength and a pharmaceutical form which are already authorised, the fee is ECU 10 000.

(2) Variation

(a) Type I variation fee

The fee for a variation of minor importance to a marketing authorisation according to the classification established by the Commission Regulation applicable to the matter is ECU 5 000.

(b) Type II variation fee

The fee for a variation of major importance to a marketing authorisation according to the classification established by the Commission Regulation applicable to the matter is ECU 60 000. It may be halved for certain Type II variations which do not involve detailed scientific evaluation, a list of which shall be drawn up in accordance with the procedure laid down in Article 11(2) of this Regulation.

(3) Renewal fee

The fee for examining information available at the time of the five-yearly renewal of an authorisation to market a medicinal product is ECU 10 000. It shall be charged for each strength associated with a pharmaceutical form.

(4) Inspection fee

The flat-rate fee for any inspection within or outside the Community is ECU 15 000. For inspections outside the Community, travel expenses will be charged extra on the basis of actual cost.

(5) Transfer fee

The fee for a change in the holder of the marketing authorisations to which the transfer relates is ECU 5 000. This covers all presentations of a given medicinal product.

(6) Annual fee

The annual fee for each medicinal product which has been granted a marketing authorisation is ECU 60 000. This covers all authorised presentations of a given medicinal product.

Article 4

Medicinal products for human use covered by the procedures laid down in Council Directive 75/319/EEC (*).

An arbitration fee of ECU 10 000 shall be payable where the procedures laid down in Articles 10(2), 11, 12, and 15 of Directive 75/319/EEC are initiated.

The fee shall be increased by ECU 40 000 where the procedures laid down in Articles 11 and 12 of Directive 75/319/EEC are initiated at the instigation of the applicant for or holder of the marketing authorisation.

(*) OJ L 147, 9.6.1975, p. 13. Directive last amended by Directive 93/39/EEC (OJ L 214, 24.8.1993, p. 22).

Article 5

Medicinal products for veterinary use covered by the procedures laid down in Council Regulation (EEC) No 2309/93

(1) Authorisation to market a medicinal product

(a) Full fee

The fee for an application for authorisation to market a medicinal product supported by a full dossier is ECU 100 000. It covers only one presentation of the medicinal product (for one strength associated with one pharmaceutical form).

The fee shall be increased by ECU 10 000 for each additional strength and/or pharmaceutical form submitted at the same time as the initial application for authorisation. This increase covers only one presentation of the additional strength and/or pharmaceutical form.

The fee shall be increased by ECU 5 000 for each additional presentation of the same strength and pharmaceutical form, submitted at the same time as the initial application for authorisation.

In the case of vaccines, the full fee is reduced to ECU 50 000, with each additional strength and/or pharmaceutical form and/or presentation entailing an increase of ECU 5 000.

For the purposes of this paragraph, the number of target species is irrelevant.

(b) Reduced fee

A reduced fee of ECU 50 000 shall apply to applications for authorisation to market a medicinal product for which a full dossier needs not to be presented, as provided for in Article 5 point 10(a)(i) and (iii) of Directive 81/851/EEC or when recourse is had to Article 5 point 10(a)(ii) of the same Directive. This fee covers a single presentation (for one strength associated with one pharmaceutical form of the medicinal product).

The fee shall be increased by ECU 10 000 for each additional strength and/or pharmaceutical form submitted at the same time as the initial application for authorisation. This increase covers only one presentation of the additional strength and/or pharmaceutical form.

The fee shall be increased by ECU 5 000 for each additional presentation of the same strength and pharmaceutical form, submitted at the same time as the initial application for authorisation.

In the case of vaccines, the fee is reduced to ECU 25 000, with each additional strength and/or pharmaceutical form and/or presentation entailing an increase of ECU 5 000.

For the purposes of this paragraph, the number of target species is irrelevant.

(c) Extension fee

This is the fee for each extension of a marketing authorisation which has already been granted:

- where the extension is for a new strength, a new pharmaceutical form or a new species, the fee is ECU 25 000;

- where the extension is for a new presentation of a strength and a pharmaceutical form which are already authorised, the fee is ECU 5 000;

- in the case of vaccines, where the extension is for a new strength, a new pharmaceutical form or a new presentation, the fee is ECU 5 000.

(2) Variation

(a) Type I variation fee

The fee for a variation of minor importance to a marketing authorisation according to the classification established by the Commission Regulation applicable to the matter is ECU 5 000. The same fee is charged in respect of vaccines.

(b) Type II variation fee

The fee for a variation of maior importance to a marketing authorisation according to the classification established by the Commission Regulation applicable to the matter is ECU 30 000. It may be halved for certain Type II variations which do not involve detailed scientific evaluation, a list of which shall be drawn up in accordance with the procedure laid down in Article 11(2) of this Regulation.

In the case of vaccines, the fee is ECU 5 000.

(3) Renewal fee

The fee for examining available information at the time of the five-yearly renewal of an authorisation to market a medicinal product is ECU 5 000. It shall be charged for each strength associated with a pharmaceutical form.

(4) Inspection fee

The flat-rate fee for any inspection within or outside the Community is ECU 15 000. For inspections outside the Community, travel expenses will be charged extra on the basis of actual cost.

(5) Transfer fee

The fee for a change in the holder of the marketing authorisations to which the transfer relates is ECU 5 000. This covers all presentations of a given medicinal product.

(6) Annual fee

The annual fee for each medicinal product which has been granted a marketing authorisation is ECU 30 000. This covers all authorised presentations of a given medicinal product.

Article 6

Medicinal products for veterinary use covered by the procedures laid down in Council Directive 81/851/EEC

Arbitration fee

An arbitration fee of ECU 10 000 shall be payable where the procedures laid down in Articles 18(2), 19, 20, and 23 of Directive 81/851/EEC are initiated.

The fee shall be increased by ECU 15 000 where the procedures laid down in Articles 19 and 20 of Directive 81/851/EEC are initiated at the instigation of the applicant for or holder of the marketing authorisation.

Article 7

Establishment of maximum residue limits (MRL) for veterinary medicinal products

(1) Fees for establishing MRL

A full MRL fee of ECU 50 000 shall be charged for an application to set an initial MRL for a given substance.

An additional MRL fee of ECU 10 000 shall be payable for each application to amend or extend an existing MRL, including to cover new species.

MRL fees will be deducted from the fee payable for an application for marketing authorisation or an application to extend a marketing authorisation for the medicinal product containing the substance for which a MRL has been set where such applications are submitted by the same applicant. However, this deduction may total no more than one half of the fee to which it applies.

(2) "Maximum residue limit for clinical trials" fee

A fee of ECU 15 000 shall be charged for any application to set a MRL with a view to clinical trials.

The fee will be deducted from the amount of the full MRL fee laid down in point 1 of this Article.

Article 8

Various fees

(1) Fee for scientific advice

This fee shall be charged where an application is made for scientific or technical advice concerning a medicinal product before an application is submitted for authorisation to market it.

- For medicinal products for human use the fee is set at ECU 60 000.

- For medicinal products for veterinary use the fee is set at ECU 30 000.

(2) Fees for administrative charges

Fees shall be payable for administrative charges when documents or certificates are issued outside the framework of services covered by another fee provided for in this Regulation or upon conclusion of the administrative validation of a dossier resulting in rejection of the application for which the dossier was submitted. The unit amount of such fees may not exceed ECU 5 000. In accordance with Article 11(2) of this Regulation, a classification shall be established and specified by the Management Board.

Article 9

Possible fee reductions

Without prejudice to more specific provisions of Community law, in exceptional circumstances and for imperative reasons of public or animal health, fee reductions may be granted case by case by the Executive Director after consultation of the competent scientific committee. Any decision taken in application of this Article shall state the reasons on which it is based.

Article 10

Due date and belated payment

1. Fees shall be payable on the date of receipt of the relevant application unless specific provisions stipulate otherwise.

The arbitration fee shall be payable within 30 days following referral to the Agency; the annual fee shall be payable within 30 days following the anniversary of the notification of the marketing authorisation decision.

The inspection fee shall be payable at the latest within 30 days following the date on which the inspection was carried out.

2. Where any fee payable under this Regulation remains unpaid at its due date, and without prejudice to the Agency's capacity to institute legal proceedings conferred on it by Article 59 of Council Regulation (EEC) No 2309/93, the Executive Director of the Agency may decide either not to provide the requested services or to suspend all the services and procedures under way until the whole of the relevant fee has been paid.

3. Fees shall be paid in ecus or in the national currency of one of the Member States according to the exchange rates in force, which shall be fixed daily by the Commission. However, monthly conversion rates based on the earlier rates may be fixed according to a calculation established by the Agency's Management Board.

Article 11

Implementing rules

1. On a proposal from the Executive Director and following a favourable opinion from the Commission, the Agency's Management Board shall fix the rules for repaying a part of the resources deriving from the annual fees to the competent national authorities involved in Community market supervision.

2. Without prejudice to the provisions of this Regulation or of Regulation (EEC) No 2309/93, the Agency's Management Board may, on a proposal from the Executive Director, specify any other provision proving necessary for the application of this Regulation.

3. In the event of disagreement as to the classification of an application in one of the fee categories laid down in this Regulation, the Executive Director shall give a ruling after consultation of the competent scientific committee.

Article 12

Amendment

Any amendment to this Regulation shall be adopted by the Council acting by a qualified majority after consulting the European Parliament.

However, amendments to the amounts of the fees established by this Regulation shall be adopted in accordance with the procedure laid down in Article 73 of Regulation (EEC) No 2309/93.

Within five years of the entry into force of this Regulation, the Commission shall present a report on its implementation, after consultation of the Agency's Management Board.`

Article 2

Entry into force

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

This Regulation shall be binding in its entirety and directly applicable in all Member States.

(1) OJ L 35, 15.2.1995, p. 1.

(2) OJ L 214, 24.8.1993, p. 1.