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Council Regulation (EC) No 297/95Show full title
Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products
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Changes over time for: Article 5
Alternative versions:
- 20/11/2005- Amendment
- 01/04/2008- Amendment
- 01/04/2009- Amendment
- 01/04/2010- Amendment
- 01/04/2011- Amendment
- 01/04/2012- Amendment
- 01/04/2013- Amendment
- 01/04/2014- Amendment
- 01/04/2015- Amendment
- 01/04/2016- Amendment
- 01/04/2017- Amendment
- 01/04/2018- Amendment
- 01/04/2019- Amendment
- Exit day: start of implementation period31/01/2020 11pm- Amendment
- 01/04/2020- Amendment
- End of implementation period31/12/2020- Amendment
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[F1Article 5U.K. [F2Medicinal products for veterinary use covered by the procedures laid down in Regulation (EC) No 726/2004]
1.
Authorisation to market a medicinal product
(a)
Full fee
[F2A full fee of [F3EUR 148 400] 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 [F3EUR 14 600] 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 [F3EUR 7 400] for each additional presentation of the same strength and pharmaceutical form, submitted at the same time as the initial application for authorisation.
[F2In the case of immunological veterinary medicinal products, the full fee shall be reduced to [F3EUR 73 800], with each additional strength and/or pharmaceutical form and/or presentation entailing an increase of [F3EUR 7 400].]
For the purposes of this point (a), the number of target species is irrelevant.
(b)
[F2Reduced fee
A reduced fee of [F3EUR 73 800] 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(1). That fee shall cover a single strength associated with one pharmaceutical form and one presentation.
A specific reduced fee of [F3EUR 125 300] 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 [F3EUR 14 600] 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 [F3EUR 7 400] 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 [F3EUR 37 100], with each additional strength and/or pharmaceutical form and/or presentation entailing an increase of [F3EUR 7 400].
For the purposes of this point, the number of target species is irrelevant.]
(c)
[F2Extension fee
An extension fee of [F3EUR 37 100] 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 [F3EUR 9 200 to EUR 27 900] 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 [F3EUR 7 400] for each additional presentation of the same extension submitted at the time of the extension application.]
2.
Variation
(a)
Type I variation fee
[F2A 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 [F3EUR 3 300]. For Type IB variations, the fee shall be [F3EUR 7 400].]
In the event of the same variation being introduced, this fee shall cover all authorised strengths, pharmaceutical forms and presentations.
(b)
[F2Type II variation fee
A Type II variation fee of [F3EUR 44 400] 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 [F3EUR 11 200 to EUR 33 500] 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 [F3EUR 7 400].
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.]
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 shall be [F3EUR 7 400]. It shall be charged for each strength associated with a pharmaceutical form.
4.
Inspection fee
[F2A fee of [F3EUR 22 400] 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.]
[F4By 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).]
5.
Transfer fee
The fee for a change in the holder of the marketing authorisations to which the transfer relates shall be [F3EUR 7 400]. This covers all authorised presentations of a given medicinal product.
6.
[F2Annual fee
An annual fee of [F3EUR 35 600] 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 [F3EUR 8 700 to EUR 26 400] 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).]]
Textual Amendments
F2Substituted by Council Regulation (EC) No 1905/2005 of 14 November 2005 amending Regulation (EC) No 297/95 on fees payable to the European Medicines Agency.
(1)
[F1 [F2 OJ L 311, 28.11.2001, p. 1 . Directive as last amended by Directive 2004/28/EC ( OJ L 136, 30.4.2004, p. 58 ).] ]
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