Article 9 Possible fee reductionsF1

Without prejudice to more specific provisions of Community law, in exceptional circumstances and for imperative reasons of public or animal health, fee reductions may be granted case by case by the Executive Director after consultation of the competent scientific committee. Any decision taken pursuant to this Article shall state the reasons on which it is based.

F2A total or partial exemption from payment of the fees laid down in this Regulation may be granted, in particular for medicinal products for treating rare diseases or diseases affecting minor animal species or for extension of existing MRL to additional animal species or for medicinal products available for compassionate use.

The detailed conditions for the application of the total or partial exemption shall be determined in accordance with Article 11(2).

The fee payable for an opinion on a medicinal product for compassionate use shall be deducted from the fee payable for an application for a marketing authorisation of the same medicinal product, where such application is submitted by the same applicant.