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Parliamentary questions
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24 August 2015
E-010588/2015(ASW)
Answer given by Mr Andriukaitis on behalf of the Commission
Question reference: E-010588/2015

In its opinion delivered in December 2014 on request of the Commission, the European Medicines Agency (EMA) concludes that risk management measures are needed to contain the risk of vultures/necrophagous birds being fed on carcasses of animals that have been treated with diclofenac but does not recommend the ban of this substance. National marketing authorisations for diclofenac-containing products for veterinary use exist in 5 Member States, the oldest dating back to 1993. It should be noted that there has been no evidence of vulture poisoning linked to diclofenac in the EU since its first authorisation. Strict rules on the disposal of fallen stock are provided for by the animal by-products legislation(1) and apply to carcasses used in feeding stations for necrophagous birds.

The Commission does not plan to draw up a study as mentioned by the Honourable Member. Before a marketing authorisation is granted, the benefit/risk balance of a medicinal product is assessed. This includes an Environmental Risk Assessment.

Suitable and effective risk management measures should be implemented by Member States, taking into account their specificities as regards both the authorisation of diclofenac for veterinary use and the presence on their territory of necrophagous birds.

The Commission discussed this issue with the Member States at a meeting of the Veterinary Pharmaceutical Committee on 15 June 2015.(2)

The risk mitigation measures of all the Member States have already been shared with stakeholders who expressed an interest in them.

(1)Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21.10.2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (Animal by-products Regulation).
(2)Summary record is available here: http://ec.europa.eu/health/files/veterinary/vetpharm__343_en.pdf

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