Pharmacovigilance

Pharmacovigilance Guidance Documents

The following links provide guidance on veterinary pharmacovigilance:


General

Volume 9B of The Rules Governing Medicinal Products in the European Union


Adverse Events

EudraVigilance

Schemas for the Guidance on the Electronic Data Interchange of Safety Data for Veterinary Medicinal Products in the EU

Questions and answers on adverse event reporting

Questions and answers on serious non-fatal adverse events and reporting rules

Recommendation on harmonising the approach to causality assessment for adverse events to veterinary medicinal products

Guidance notes on the use of VeDDRA terminology for reporting suspected adverse reactions in animals and humans

VICH GL24 – Pharmacovigilance of veterinary medicinal products: management of adverse event reports (AERs)

VICH GL42 – Pharmacovigilance of Veterinary Medicinal Products – Data Elements for Submission of Adverse Event Reports


PSURs

Recommendation on management and assessment of periodic safety update reports (PSURs) of veterinary medicinal products

Questions and answers related to management and assessment of periodic safety update reports (PSURs)

Best Practice Guide for handling of PSURs for VMPs authorised via MRP/DCP

VICH GL29 – Pharmacovigilance of Veterinary Medicinal Products – Management of Periodic Summary Update Reports


Other

Reflection paper on pharmacovigilance communication concerning veterinary medicinal products

Further guidance can be found on the EMA and VICH websites.

Pharmacovigilance Inspections: Veterinary

In order to determine that marketing authorisation holders (MAHs) of veterinary products comply with pharmacovigilance requirements established by EU legislation, and to facilitate compliance, pharmacovigilance inspections are performed of veterinary MAHs or any firms employed to fulfil the MAH duties.

During these inspections HPRA personnel review the procedures, systems, personnel and facilities in place and determine their compliance with the requirements.

Product-related pharmacovigilance inspections are primarily focused on product-related pharmacovigilance issues, including product-specific activities and documentation, rather than a general system review. Some aspects of the general system may still be examined as part of a product-related inspection.

Pharmacovigilance inspections may be performed on a routine basis or may be scheduled in response to a request from another department or committee of the HPRA where there is a specific cause for concern with respect to compliance with guidelines or regulations.  A request for a routine or triggered inspection may also be received from the European Medicines Agency’s Committee for Medicinal Products for Veterinary Use (CVMP).