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<p> </p><p>Authorisation of a veterinary medicine involves an assessment of the benefits
of a product against its risks. Potential risks include risks to the animal, to the
user, the consumer and to the environment. The environmental risk is assessed to establish
the extent of exposure. If the environmental exposure is not extensive, then no further
assessment is required. Without exposure, there is no risk irrespective of the toxicity.
If there is information in the public domain to indicate that despite low exposure
there may be a potential risk, then the competent authority – the body that authorises
veterinary medicines - can request a further assessment of the issues identified.</p><p>
</p><p> </p><p> </p><p>Products containing Diclofenac are a risk to vultures if there
is any exposure of the birds to carcasses of animals containing residues of the veterinary
medicine. The toxicity of Diclofenac to vultures is well documented. In Europe there
are laws which provide for the disposal of fallen stock. The risk of exposure is therefore
minimal as dead farmed animals are not left in the fields. Risk mitigation measures
(instructions to the users) could be used to eliminate exposure by instructing users
not to feed carcasses of animals treated with Diclofenac to vultures. This is something
for the competent authorities of those Member States that have authorised the veterinary
use of Diclofenac. The Government has no evidence that there is a serious risk to
vultures posed by the authorisation of Diclofenac and therefore does not plan to trigger
a referral procedure.</p><p> </p>
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