‘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;
ciallaíonn “próiseas bainistithe comharthaí” próiseas chun faireachas gníomhach a dhéanamh ar shonraí faireachais cógas maidir le táirgí íocshláinte tréidliachta chun na sonraí faireachais cógas a mheas agus a chinneadh an bhfuil aon athrú ar chothromaíocht sochair-riosca na dtáirgí íocshláinte tréidliachta sin, d’fhonn rioscaí do shláinte ainmhithe nó do shláinte phoiblí nó do chosaint an chomhshaoil a bhrath;