Pharmacovigilance

Pharmacovigilance means the monitoring and evaluation of adverse events and improving the safety of medicines. In the case of veterinary medicines, it includes the safety of the medicine for:

• The treated animal,
• The consumer (if relevant),
• The environment of the treated animal,
• Medicine users, or any person in contact with the treated animal. 

Pharmacovigilance legislation

The requirements for veterinary pharmacovigilance are set by European legislation. The requirements, including the management of any adverse event signals reported, apply to:

• Marketing authorisation holders of veterinary medicines,
• Holders of registrations of homeopathic veterinary medicines,
• Companies marketing veterinary medicines that are authorised in accordance with Article 5(6) of Regulation (EU) 2019/6 (certain species kept exclusively as pets).

Additional information is available in the relevant guidance on good pharmacovigilance practices.

Pharmacovigilance inspections

To ensure compliance pharmacovigilance requirements, the HPRA may conduct pharmacovigilance inspections of the companies involved. During these inspections, we review the procedures, systems, personnel, and facilities to determine compliance with the requirements.

Product-related inspections primarily focus on issues related to specific products, rather than conducting a general system review. However, certain aspects of the general system may be examined as part of a product-related inspection.

Pharmacovigilance inspections may be performed on a routine basis or triggered in response to a specific concern about compliance with guidelines or regulations. The European Medicines Agency (EMA) may also request the HPRA to conduct an inspection.