Legal provisions of COM(1994)167 - Fees payable to the european medicines evaluation agency - Main contents
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dossier | COM(1994)167 - Fees payable to the european medicines evaluation agency. |
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document | COM(1994)167 ![]() |
date | February 10, 1995 |
Contents
- Article 1 - Scope
- Article 2
- Article 3 - Applications for authorization for medicinal products for human use under the centralized procedure
- Article 4 - Settlement of disagreements on applications for authorizations for medicinal products for human use under the decentralized procedure
- Article 5 - Applications for authorizations for veterinary medicinal products under the centralized procedure
- Article 6 - Settlement of disagreements on applications for authorizations for veterinary medicinal products under the decentralized procedure
- Article 7 - Waivers, fee reductions and settlement of disagreements
- Article 8 - Due date and belated payment
- Article 9 - Implementing rules
- Article 10
- Article 11 - Entry into force and legal effect
Article 1 - Scope
2. Fees shall be laid down in ecus.
Article 2
Article 3 - Applications for authorization for medicinal products for human use under the centralized procedure
This is the fee for an application for a Community authorization to market a medicinal product supported by a full dossier. It shall be increased by ECU 20 000 for each additional strength and/or pharmaceutical form of the same medicinal product submitted at the same time as the initial application for authorization. However, the total amount of this fee may not exceed ECU 200 000.
2. Reduced fee: ECU 70 000
This is the fee for an application for a Community authorization to market a medicinal product not required to be supported by a full dossier as provided for under the exceptions in point 8 of the second paragraph of Article 4 of Directive 65/65/EEC. It shall be increased by ECU 10 000 for each additional strength and/or pharmaceutical form of the same medicinal product submitted at the same time as the initial application for authorization. However, the total amount of this fee may not exceed ECU 100 000.
3. Extension fee: ECU 40 000
This is the fee for each additional application for a Community authorization to market a medicinal product made for a strength and/or pharmaceutical form after an initial application for authorization has been submitted to the Agency.
4. Type I variation fee: ECU 5 000
This is the fee for a variation of minor importance according to the classification established by the Commission Regulation applicable to the matter.
5. Type II variation fee: ECU 40 000
This is the fee for a variation of major importance according to the classification established by the Commission Regulation applicable to the matter.
6. Renewal fee: ECU 10 000
This is the fee for review of the available new information about the medicinal product at the time of the obligatory five-yearly renewal of a Community marketing authorization for that product granted for each strength and/or pharmaceutical form.
7. Inspection fee: ECU 10 000
This is the flat-rate fee for any inspection within or outside the Community. For inspections outside the Community travel expenses will be charged extra on the basis of the actual cost.
8. Transfer fee: ECU 5 000
This is the fee for a change in the holder of each marketing authorization to which the transfer relates.
Article 4 - Settlement of disagreements on applications for authorizations for medicinal products for human use under the decentralized procedure
This is the flat-rate fee paid by the undertaking concerned to the Agency for arbitration of disagreements between Member States on the mutual recognition of a national marketing authorization of of a type II variation to be made to an existing national authorization. This fee shall also be charged where the procedures provided for in Articles 11 and 12 of Directive 75/319/EEC (4), are initiated at the instigation of the person responsible for placing medicinal products on the market.
Article 5 - Applications for authorizations for veterinary medicinal products under the centralized procedure
This is the fee for an application for a Community authorization to market a medicinal product for use in food producing animals supported by a full dossier. It shall be increased by ECU 10 000 for each additional strength and/or pharmaceutical form of the same medicinal product submitted at the same time as the initial application. However, the total amount of this fee may not exceed ECU 100 000.
In the case of vaccines, the full fee is ECU 40 000, each additional strength and/or pharmaceutical form entailing an increase of ECU 5 000.
2. Reduced fee: ECU 35 000
This is the fee for an application for a Community authorization to market a medicinal product not required to be supported by a full dossier as provided for under the exceptions in point 10 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 shall be increased by ECU 5 000 for each additional strength, and/or pharmaceutical form of the same medicinal product or for a different species, submitted at the same time as the initial application. However, the total amount of this fee may not exceed ECU 50 000.
In the case of vaccines, the reduced fee is ECU 20 000, each additional strength and/or pharmaceutical form entailing an increase of ECU 5 000.
3. Maximum residue limits (MRL) fee: ECU 40 000
This is the fee for an application for the first MRL to be established for a substance. The fee for each request for modification or extension of an existing MRL shall be ECU 10 000.
This fee shall be deducted from that charged for a marketing authorization for a medicinal product containing the substance where such authorization is applied for by the undertaking originating the establishment of the MRL.
4. Extension fee: ECU 20 000
This is the fee for each additional application for a Community authorization to market a medicinal product made for a strength and/or pharmaceutical form after an initial application for authorization has been submitted to the Agency.
Unless an additional application for a strength and/or pharmaceutical form is made at the same time, this fee shall also be paid for an additional application to market the product for use in one or more additional species.
In the case of vaccines the additional fee shall be ECU 10 000.
5. Type I Variation fee: ECU 5 000
This is the fee for a variation of minor importance according to the classification established by the Commission Regulation applicable to the matter.
6. Type II Variation free: ECU 20 000
This is the fee for a variation of major importance according to the classification established by the Commission Regulation applicable to the matter.
7. Renewal fee: ECU 5 000
This is the fee for review of any available new information about the medicinal product at the time of the obligatory five-year renewal of a Community marketing authorization for that product granted for each strength, pharmaceutical form and/or species provided that species has been the subject of an extension fee within the meaning of paragraph 4 of this Article.
8. Inspection fee: ECU 10 000
This is the flat-rate fee for any inspection within or outside the Community. For inspections outside the Community travel expenses will be charged extra on the basis of the actual cost.
9. Transfer fee: ECU 5 000
This is the fee for a change in the holder of each marketing authorization to which the transfer relates.
Article 6 - Settlement of disagreements on applications for authorizations for veterinary medicinal products under the decentralized procedure
This is the flat-rate fee paid by the undertaking concerned to the Agency for arbitration of disagreements between Member States on the mutual recognition of a national marketing authorization or of a type II variation to be made to an existing national authorization. This fee shall also be charged where the procedures provided for in Articles 19 and 20 of Directive 81/851/EEC, as amended, are initiated at the instigation of the person responsible for placing medicinal products on the market.
Article 7 - Waivers, fee reductions and settlement of disagreements
The general criteria for granting waivers and reductions shall be determined by the Agency's Management Board.
2. A procedure similar to that described in the first subparagraph of paragraph 1 shall apply to any disagreement which may arise on the classification of an application under one of the above fee categories.
Article 8 - Due date and belated payment
2. Where any fee payable under this Regulation remains unpaid at its due date the Executive Director may decide either not to provide or to suspend the services requested until 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 in accordance with Regulation (EEC) No 3180/78 (5). However, the Agency's Management Board may fix monthly conversion rates on the basis of earlier rates.
Article 9 - Implementing rules
Article 10
However, amendments to the amounts of the various fees laid down in this Regulation shall be made in accordance with the procedure laid down in Article 73 of Regulation (EEC) No 2309/93.
Article 11 - Entry into force and legal effect
This Regulation shall be binding in its entirety and directly applicable in all Member States.