# The Veterinary Medicines Regulations 2013, Paragraph 56C: Signal management process

Extent: E+W+S

(1) For the purposes of these Regulations, “signal management process” means a process for performing active surveillance of pharmacovigilance data for veterinary medicinal products in order to assess the pharmacovigilance data and determine whether there is any change to the benefit-risk balance of those veterinary medicinal products, with a view to detecting risks to animal or public health or protection of the environment.
(2) A signal management process must consist of tasks of signal detection, validation, confirmation, analysis and prioritisation, assessment and recommendation for action.
(3) A signal management process must be capable of identifying, at a minimum, in relation to a product—
(a) a sudden and unexpected increase in the number of adverse events;
(b) an unexpected increase in the frequency of a known clinical sign;
(c) a new clinical sign;
(d) reports in scientific literature of any of the matters mentioned in paragraphs (a) to (c).

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Source: https://www.legislation.gov.uk/uksi/2013/2033/schedule/1/paragraph/56C (the official version)
Page: https://openlegislation.uk/veterinary-medicines-regulations-2013/schedule-1/paragraph-56C
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.