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1. Annual fee for medicinal products for human use authorised in accordance with Regulation (EC) No 726/2004 1.1. An annual fee of EUR 60 300 shall apply to each marketing authorisation of a medicinal product for human use authorised on the basis of an application submitted under Article 10(1) and (3) and Article 10c of Directive 2001/83/EC. The remuneration shall be EUR 8 000 for the rapporteur, EUR 7 000 for the co-rapporteur and EUR 1 500 for the PRAC rapporteur.

1.2. An annual fee of EUR 118 100 shall apply to each marketing authorisation of a medicinal product for human use authorised on the basis of an application submitted under Article 10(4) of Directive 2001/83/EC. The remuneration shall be EUR 16 200 for the rapporteur, EUR 14 300 for the co-rapporteur and EUR 3 000 for the PRAC rapporteur.

1.3. An annual fee of EUR 232 400 shall apply to each marketing authorisation of a medicinal product for human use not covered by point 1.1 or 1.2. The remuneration shall be EUR 32 200 for the rapporteur, EUR 28 400 for the co-rapporteur and EUR 6 100 for the PRAC rapporteur.

1.4. The annual fees as specified in points 1.1, 1.2 and 1.3 shall relate to the preceding year.

2. Annual fee for veterinary medicinal products authorised through the centralised procedure in accordance with Regulation (EU) 2019/6 2.1. An annual fee of EUR 26 200 shall apply to each marketing authorisation of a veterinary medicinal product authorised pursuant to Article 18, 19 or 21 of Regulation (EU) 2019/6. The remuneration shall be EUR 6 300 for the rapporteur and EUR 5 800 for the co-rapporteur.

2.2. An annual fee of EUR 106 400 shall apply to each marketing authorisation of a veterinary medicinal product not covered by point 2.1. The remuneration shall be EUR 25 600 for the rapporteur and EUR 23 500 for the co-rapporteur.

2.3. The annual fees as specified in points 2.1 and 2.2 shall relate to the preceding year.

3. Annual pharmacovigilance fee for medicinal products for human use authorised in accordance with Directive 2001/83/EC and for veterinary medicinal products authorised by competent authorities of the Member States in accordance with Regulation (EU) 2019/6 3.1. For medicinal products for human use authorised in accordance with Directive 2001/83/EC, a fee of EUR 230 per chargeable unit in relation to medicinal products for human use, shall apply once per year for the Agency’s pharmacovigilance activities including analysis of Union-wide health data to support better decision-making with real world evidence. The Agency shall retain the fee revenue from the annual pharmacovigilance fee.

3.2. For veterinary medicinal products authorised by competent authorities of the Member States in accordance with Chapter III, Sections 2 to 5, of Regulation (EU) 2019/6, a fee of EUR 90 per chargeable unit in relation to veterinary medicinal products shall apply once per year for the Agency’s pharmacovigilance activities. The Agency shall retain the fee revenue from the annual pharmacovigilance fee.

3.3. The total payable amount of the annual fees referred to in points 3.1 and 3.2 for each marketing authorisation holder shall be calculated by the Agency on the basis of the number of chargeable units in relation to medicinal products for human use and chargeable units in relation to veterinary medicinal products, respectively, which correspond to the information recorded on 1 July each year.

3.4. The annual fees referred to in points 3.1 and 3.2 shall be due on 1 July every year and shall cover the period from 1 January to 31 December of that calendar year.