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Parliamentary questions
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5 January 2018
Answer given by Mr Andriukaitis on behalf of the Commission
Question reference: E-007074/2017

The Commission has taken several actions in relation to the use of diclofenac in the EU.

The Member States were requested to carry out an analysis of the risk mitigation measures recommended by the European Medicines Agency (EMA) in its opinion of 11 December 2014(1) and to indicate in an action plan the measures that have been already implemented or that they would consider to put in place in the future.

It should be noted in this respect that veterinary medicinal products containing diclofenac have been authorised only through the national authorisation procedure in a limited number of Member States.

At the meeting of the Veterinary Pharmaceutical Committee that took place on 15 June 2015(2), it was agreed that the mitigation measures implemented by the Member States should guarantee that where diclofenac is used and vultures (or other relevant necrophagous birds) are present on the territory, they would be able to contain the risk effectively.

Given the Commission’s commitment to follow up on this issue, Member States were invited during the Veterinary Pharmaceutical Committees that took place on 4 July 2016 and on 19 June 2017 to provide an update of the situation in their territories(3).

Most Member States indicated that they have not authorised diclofenac. Those that have authorised products containing diclofenac indicated that appropriate safety warnings were included in the product literature and that appropriate measures are in place for the safe disposal of fallen stock and the feeding of carrion to birds of prey.

None of the Member States reported deaths of vultures in their territories and no request was made for the initiation of a referral where the withdrawal of the marketing authorisations of products containing diclofenac would be considered.


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