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).