Not treated for

The efficacy results obtained shall be compared with those from the target animal species that have received a veterinary medicinal product authorised in the Union for the same indications for use in the same target animal species, or a placebo or no treatment.

15. Notes, that the contribution to the European Medicines Agency for 2015, as requested by the Agency and as adopted by the Commission amounts to EUR 31,516 million; is aware that to this amount, the 2013 outturn of EUR 1,499 million needs to be added, reaching a total contribution of EUR 33,015 million in 2015; points out that the proposed contribution does not cover any additional contribution relating to the implementation of the Pharmacovigilance legislation, as the costs of this activity are to be covered by fees; recalls that Regulation (EU) No 658/2014 of the European Parliament and of the Council entered ...[+++]into force in July 2014 and that the Agency will have to adapt its existing human and financial resources to cover the Pharmacovigilance activities; stresses that the European Medicines Agency is one of the industry-driven agencies which, in the last four years, has not received one additional post for the implementation of the Pharmacovigilance legislation resulting in a slow-down of handling files;

22. Stresses that the European Medicines Agency is one of the industry-driven agencies which, in the last three years, has not received one additional post for the implementation of the Pharmacovigilance legislation resulting in a slow-down of handling files; will not accept the Commission's approach in this regard as well as the foreseen cut of 2% (equivalent to a reduction of 12 posts) applied to the whole agency staff while 5/6 of staff is fee-financed;

Whilst the proposal foresees a so-called 'end of application' for derived products intended for further processing, treatment or transformation in specialized plants (e.g. cosmetic products, medicinal products.), it would only be logic to foresee such end of application for finished products which will not be further treated, transformed or processed, but which are put on the market in ready-to-sale packaging, such as pet food produced according to the safety requirements of the regulation.