Pharmacovigilance Inspections: Veterinary

Pharmacovigilance inspections of companies are required by law in order to ensure that veterinary medicines supplied to the market by them comply with EU requirements. There are two main types of inspections:

  • Pharmacovigilance system inspections:  these are designed to review the documentation, procedures, systems, personnel and facilities that a company has in place to meet their pharmacovigilance obligations (such as handling any reports of suspected adverse events). 

  • Product-related pharmacovigilance inspections: these are primarily focused on particular products and any supporting documentation, rather than a general system review. Some aspects of the general system may still be examined as part of a product-related inspection (e.g. the system used for that product).

Pharmacovigilance inspections may be performed by the HPRA on a routine basis or may be scheduled in response to a specific request where there is a cause for concern with respect to compliance with guidelines or regulations.  A request for a routine or triggered inspection may be initiated by the European Medicines Agency.