Article 3 Medicinal products for human use covered by the procedures laid down in Regulation (EC) No 726/2004F1F2

Authorisation to market a medicinal product

1. (a)

   Full fee

   A full fee of F3EUR 296 500 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 29 800 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 7 400 for each additional presentation of the same strength and pharmaceutical form, submitted at the same time as the initial application for authorisation.

2. (b)

   Reduced fee

   A reduced fee of EUR 115 100 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^f1. That fee shall cover a single strength associated with one pharmaceutical form and one presentation.

   A specific reduced fee of EUR 191 700 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 11 500 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 7 400 for each additional presentation of the same strength and pharmaceutical form, submitted at the same time as the initial application for authorisation.

3. (c)

   Extension fee

   An extension fee of EUR 89 000 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^f2, which has already been granted.

   By derogation from the first subparagraph, a reduced extension fee falling within the range of EUR 22 400 to EUR 66 800 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 7 400 for each additional presentation of the same extension submitted at the time of the extension application.

Variation

1. (a)

   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 3 300. For Type IB variations, the fee shall be EUR 7 400.

   In the event of the same variation being introduced, this fee shall cover all authorised strengths, pharmaceutical forms and presentations.

2. (b)

   Type II variation fee

   A Type II variation fee of EUR 89 000 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 22 400 to EUR 66 800 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.

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 14 600. It shall be charged for each strength associated with a pharmaceutical form.

Inspection fee

A fee of EUR 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).

Transfer fee

The fee for a change in the holder of the marketing authorisations to which the transfer relates shall be EUR 7 400. This covers all authorised presentations of a given medicinal product.

Annual fee

An annual fee of EUR 106 300 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 26 400 to EUR 79 700 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).