Fees for obtaining and maintaining a Community authorisation to market medicinal products for human and veterinary use and for other services supplied by the Agency shall be levied in accordance with this Regulation.
Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products
Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products
Article 1 Scope
The amounts of these fees shall be laid down in euro.
Article 2
The Agency shall indicate in its annual estimate intended for the establishment of the preliminary draft budget of the Commission the estimates concerning the fees for the following financial year, and this shall be done separately from the estimating of the overall expenditure and the possible contribution by the Community.
Article 3 Medicinal products for human use covered by the procedures laid down in Regulation (EC) No 726/2004 OJ L 136, 30.4.2004, p. 1.
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Authorisation to market a medicinal product
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Full fee
A full fee of EUR 286 900 shall apply for an application for a marketing authorisation supported by a full dossier. That fee shall cover a single strength associated with one pharmaceutical form and one presentation.
The fee shall be increased by EUR 28 800 for each additional strength and/or pharmaceutical form submitted at the same time as the initial application for authorisation. That increase shall cover one additional strength or pharmaceutical form and one presentation.
The fee shall be increased by EUR 7 200 for each additional presentation of the same strength and pharmaceutical form, submitted at the same time as the initial application for authorisation.
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Reduced fee
A reduced fee of EUR 111 400 shall apply to applications for a marketing authorisation pursuant to Article 10(1) and (3), and Article 10c of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use(2). That fee shall cover a single strength associated with one pharmaceutical form and one presentation.
A specific reduced fee of EUR 185 500 shall apply to applications for a marketing authorisation pursuant to Article 10(4) of Directive 2001/83/EC. That fee shall cover a single strength associated with one pharmaceutical form and one presentation.
The reduced fees referred to in the first and second subparagraph shall be increased by EUR 11 100 for each additional strength or pharmaceutical form submitted at the same time as the initial application for authorisation. That increase shall cover one additional strength or pharmaceutical form and one presentation.
The reduced fees referred to in the first and second subparagraph shall be increased by EUR 7 200 for each additional presentation of the same strength and pharmaceutical form, submitted at the same time as the initial application for authorisation.
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Extension fee
An extension fee of EUR 86 100 shall apply for each extension of a marketing authorisation within the meaning of Annex II to Commission Regulation (EC) No 1085/2003 of 3 June 2003 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products falling within the scope of Council Regulation (EEC) No 2309/93(3), which has already been granted.
By derogation from the first subparagraph, a reduced extension fee falling within the range of EUR 21 600 to EUR 64 600 shall apply for certain extensions. Those extensions shall be included in a list, which shall be drawn up in accordance with Article 11(2) of this Regulation.
The extension fee and the reduced extension fee shall be increased by EUR 7 200 for each additional presentation of the same extension submitted at the time of the extension application.
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Variation
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Type I variation fee
A Type I variation fee shall apply for a minor variation to a marketing authorisation, as defined in Article 3(2) of Regulation (EC) No 1085/2003. For Type IA variations, the fee shall be EUR 3 100. For Type IB variations, the fee shall be EUR 7 200.
In the event of the same variation being introduced, this fee shall cover all authorised strengths, pharmaceutical forms and presentations.
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Type II variation fee
A Type II variation fee of EUR 86 100 shall apply for a major variation to a marketing authorisation, as defined in Article 3(3) of Regulation (EC) No 1085/2003.
By derogation from the first subparagraph, a reduced Type II variation fee falling within the range of EUR 21 600 to EUR 64 600 shall apply for certain variations. Those variations shall be included in a list, which shall be drawn up in accordance with Article 11(2) of this Regulation.
In the event of the same variation being introduced, this fee shall cover all authorised strengths, pharmaceutical forms and presentations.
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Renewal fee
The fee for examininginformation available at the time of the five-yearly renewal of an authorisation to market a medicinal product shall be EUR 14 200. It shall be charged for each strength associated with a pharmaceutical form.
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Inspection fee
A fee of EUR 21 600 shall apply for any inspection within or outside the Community. For inspections outside the Community, travel expenses shall be charged extra on the basis of actual cost.
By derogation from the first subparagraph, a reduced inspection fee shall apply for certain inspections, according to the extent and nature of the inspection and on the basis of the conditions laid down in accordance with Article 11(2).
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Transfer fee
The fee for a change in the holder of the marketing authorisations to which the transfer relates shall be EUR 7 200. This covers all authorised presentations of a given medicinal product.
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Annual fee
An annual fee of EUR 102 900 shall apply for each marketing authorisation of a medicinal product. That fee shall cover all authorised presentations of a given medicinal product.
By derogation from the first subparagraph, a reduced annual fee falling within the range of EUR 25 600 to EUR 77 100 shall apply for certain types of medicinal products. Those medicinal products shall be included in a list, which shall be drawn up in accordance with Article 11(2).
Article 4 Medicinal products for human use covered by the procedures laid down in Directive 2001/83/EC
Referral fee
A referral fee of EUR 71 400 shall apply where the procedures laid down in Article 30(1) and Article 31 of Directive 2001/83/EC are initiated by the applicant of a marketing authorisation or the holder of an existing marketing authorisation.
Where more than one applicant of marketing authorisations or holder of existing marketing authorisations are concerned by the procedures referred to in the first subparagraph, the applicants or holders may be grouped for the purpose of the payment of one single referral fee. If however, the same procedure concerns more than ten different applicants or holders, the fee shall be charged by the application of the abovementioned referral fee.
Article 5 Medicinal products for veterinary use covered by the procedures laid down in Regulation (EC) No 726/2004
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Authorisation to market a medicinal product
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Full fee
A full fee of EUR 143 700 shall apply for an application for a marketing authorisation supported by a full dossier. That fee shall cover a single strength associated with one pharmaceutical form and one presentation.
The fee shall be increased by EUR 14 200 for each additional strength and/or pharmaceutical form submitted at the same time as the initial application for authorisation. That increase shall cover one additional strength or pharmaceutical form and one presentation.
The fee shall be increased by EUR 7 200 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 immunological veterinary medicinal products, the full fee shall be reduced to EUR 71 400, with each additional strength and/or pharmaceutical form and/or presentation entailing an increase of EUR 7 200.
For the purposes of this point (a), the number of target species is irrelevant.
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Reduced fee
A reduced fee of EUR 71 400 shall apply to applications for a marketing authorisation pursuant to Article 13(1) and (3), and Article 13c of Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products(4). That fee shall cover a single strength associated with one pharmaceutical form and one presentation.
A specific reduced fee of EUR 121 200 shall apply to applications for a marketing authorisation pursuant to Article 13(4) of Directive 2001/82/EC. That fee shall cover a single strength associated with one pharmaceutical form and one presentation.
The reduced fees referred to in the first and second subparagraph shall be increased by EUR 14 200 for each additional strength or pharmaceutical form submitted at the same time as the initial application for authorisation. That increase shall cover one additional strength or pharmaceutical form and one presentation.
The reduced fees referred to in the first and second subparagraph shall be increased by EUR 7 200 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 immunological veterinary medicinal products, the fee shall be reduced to EUR 35 900, with each additional strength and/or pharmaceutical form and/or presentation entailing an increase of EUR 7 200.
For the purposes of this point, the number of target species is irrelevant.
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Extension fee
An extension fee of EUR 35 900 shall apply for each extension of a marketing authorisation within the meaning of Annex II to Regulation (EC) No 1085/2003, which has already been granted.
By derogation from the first subparagraph, a reduced extension fee falling withn the range of EUR 8 900 to EUR 27 000 shall apply for certain extensions. Those extensions shall be included in a list, which shall be drawn up in accordance with Article 11(2) of this Regulation.
The extension fee and the reduced extension fee shall be increased by EUR 7 200 for each additional presentation of the same extension submitted at the time of the extension application.
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Variation
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Type I variation fee
A Type I variation fee shall apply for a minor variation to a marketing authorisation, as defined in Article 3(2) of Regulation (EC) No 1085/2003. For Type IA variations, the fee shall be EUR 3 100. For Type IB variations, the fee shall be EUR 7 200.
In the event of the same variation being introduced, this fee shall cover all authorised strengths, pharmaceutical forms and presentations.
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Type II variation fee
A Type II variation fee of EUR 43 000 shall apply for a major variation to a marketing authorisation, as defined in Article 3(3) of Regulation (EC) No 1085/2003.
By derogation from the first subparagraph, a reduced Type II variation fee falling within the range of EUR 10 800 to EUR 32 400 shall apply for certain variations. Those variations shall be included in a list, which shall be drawn up in accordance with Article 11(2) of this Regulation.
In the case of immunological veterinary medicinal products, the fee shall be EUR 7 200.
In the event of the same variation being introduced, the fee referred to in the first, second and third subparagraph shall cover all authorised strengths, pharmaceutical forms and presentations.
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Renewal fee
The fee for examining information available at the time of the five-yearly renewal of an authorisation to market a medicinal product shall be EUR 7 200. It shall be charged for each strength associated with a pharmaceutical form.
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Inspection fee
A fee of EUR 21 600 shall apply for any inspection within or outside the Community. For inspections outside the Community, travel expenses shall be charged extra on the basis of actual cost.
By derogation from the first subparagraph, a reduced inspection fee shall apply for certain inspections, according to the extent and nature of the inspection and on the basis of the conditions laid down in accordance with Article 11(2).
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Transfer fee
The fee for a change in the holder of the marketing authorisations to which the transfer relates shall be EUR 7 200. This covers all authorised presentations of a given medicinal product.
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Annual fee
An annual fee of EUR 34 400 shall apply for each marketing authorisation of a medicinal product. That fee shall cover all authorised presentations of a given medicinal product.
By derogation from the first subparagraph, a reduced annual fee falling within the range of EUR 8 500 to EUR 25 600 shall apply for certain types of medicinal products. Those medicinal products shall be included in a list, which shall be drawn up in accordance with Article 11(2).