4.

Article 5 is amended as follows: (a) the title shall be replaced by the following: ‘Medicinal products for veterinary use covered by the procedures laid down in Regulation (EC) No 726/2004’; (b) paragraph 1 is amended as follows: (i) point (a) shall be amended as follows: — the first and second subparagraph shall be replaced by the following: ‘A full fee of EUR 116 000 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 11 600 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 fourth subparagraph shall be replaced by the following: ‘In the case of immunological veterinary medicinal products, the full fee shall be reduced to EUR 58 000, with each additional strength and/or pharmaceutical form and/or presentation entailing an increase of EUR 5 800.’; (ii) point (b) shall be replaced by the following: ‘(b) Reduced fee A reduced fee of EUR 58 000 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 (10). That fee shall cover a single strength associated with one pharmaceutical form and one presentation. A specific reduced fee of EUR 98 000 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 11 600 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 EUR 5 800 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 29 000, with each additional strength and/or pharmaceutical form and/or presentation entailing an increase of EUR 5 800. For the purposes of this point, the number of target species is irrelevant. (10) 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).’;" (iii) point (c) shall be replaced by the following: ‘(c) Extension fee An extension fee of EUR 29 000 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 7 200 to EUR 21 700 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 5 800 for each additional presentation of the same extension submitted at the time of the extension application.’; (c) paragraph 2 is amended as follows: (i) in point (a) the first subparagraph shall be replaced by the following: ‘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 2 500. For Type IB variations, the fee shall be EUR 5 800.’; (ii) point (b) shall be replaced by the following: ‘Type II variation fee A Type II variation fee of EUR 34 800 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 8 700 to EUR 26 100 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 5 800. 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.’; (d) paragraph 4 is amended as follows: (i) the sole subparagraph shall be replaced by the following: ‘A fee of EUR 17 400 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.’; (ii) the following subparagraph shall be added: ‘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).’; (e) paragraph 6 shall be replaced by the following: ‘6. Annual fee An annual fee of EUR 27 700 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 6 900 to EUR 20 800 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).’;