Fee deferrals
1. The payment of the following fees shall be deferred until the notification of the final decision on the marketing authorisation is issued, or the application is withdrawn:
(a)
the fee for an application for a marketing authorisation of a medicinal product, as referred to in points (a) and (b) of Article 3(1) and points (a) and (b) of Article 5(1) of Regulation (EC) No 297/95;
(b)
the fee for inspections undertaken for the purpose of assessing a marketing authorisation application for a medicinal product, as referred to in Article 3(4) and Article 5(4) of Regulation (EC) No 297/95.
2. The fees referred to in paragraph 1 shall be payable within 45 days of the date of the notification of the final decision on the marketing authorisation, or within 45 days of the date of the notification of withdrawal of the application.
Conditional fee exemption
Without prejudice to Article 5, where an application for marketing authorisation is submitted for a medicinal product on which scientific advice has already been given by the Agency, the fee payable to the Agency for the examination of that application shall be due only if a marketing authorisation is granted.
Fee reductions
1. The following reductions shall apply:
(a)
in the case of inspections a 90 % reduction to the inspection fee, as referred to in Article 3(4) and Article 5(4) of Regulation (EC) No 297/95;
(b)
in the case of scientific advice a 90 % reduction to the scientific advice fee, as referred to in Article 8(1) of Regulation (EC) No 297/95;
(c)
in the case of scientific services a 90 % reduction to the scientific service fee, as referred to in Article 8(2) of Regulation (EC) No 297/95.
2. The administrative services, as referred to in Article 8(3) of Regulation (EC) No 297/95, shall be provided free of charge, except where those services concern the parallel distribution of medicinal products, as referred to in Article 57(1)(o) of Regulation (EC) No 726/2004.
3. By derogation from points (b) and (c) of paragraph 1, scientific advice and scientific services for designated orphan medicinal products as referred to in Regulation (EC) No 141/2000 of the European Parliament and of the Council ( 7 ) shall be provided free of charge.
Fee reduction for the establishment of maximum residue limits for veterinary medicinal products
1. A 90 % reduction shall apply to the full and additional maximum residue limits (MRL) fees, as referred to in Article 7 of Regulation (EC) No 297/95.
2. The reduction referred to in paragraph 1 shall not be taken into account when calculating the deduction of the MRL fees from the fee payable for an application for a marketing authorisation or an application to extend a marketing authorisation, for a medicinal product containing the substance for which the MRL concerned has been set, where such applications are submitted by the same applicant.
However, this deduction shall not exceed one half of the fee to which it applies.
Multiple fee reductions
By derogation from Articles 7 and 8, where the applicant could, in respect of the same fee, also benefit from other reductions provided for in Community legislation, the provisions which are the most favourable to the applicant shall apply.
Cumulative fee reductions for a given fee and a given applicant shall not be allowed.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
