Paragraph 56C Signal management processF1

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.

A signal management process must consist of tasks of signal detection, validation, confirmation, analysis and prioritisation, assessment and recommendation for action.

A signal management process must be capable of identifying, at a minimum, in relation to a product—