Pharmacovigilance procedures for veterinary medicines

Work instructions for management of the procedure for assessment of the final report of Post-Authorisation Safety Studies (PASS) for veterinary medicines

Adopted Reference Number: WIN/V/4028 Legal effective date: 26/02/2016 Summary:

This WIN applies to the Pharmacovigilance team in the Animal and Public Health service of the Veterinary Medicines Division responsible for processing the assessment of final study report on post-authorisation safety studies.

Standard operating procedure for procedure to be followed when the incident management plan for medicines for veterinary use is triggered

Adopted Reference Number: SOP/V/4003 Legal effective date: 26/02/2016

Standard operating procedure for annual review of VeDDRA list to be used in EudraVigilance Veterinary

Adopted Reference Number: SOP/V/4019 Legal effective date: 15/05/2015

Standard operating procedure for management of pharmacovigilance rapid alerts and non-urgent information for medicinal products for veterinary use

Adopted Reference Number: SOP/V/4041 Legal effective date: 09/08/2013