Reporting adverse events for a medicine used in an animal – information for marketing authorisation holders

Marketing Authorisation Holders (MAHs) must report certain types of adverse events to the Union Pharmacovigilance Database (UPhD). This is required by law under Article 73(2) of Regulation (EU) 2019/6.

What you must report

MAHs must record and report the following suspected adverse events.

  • Unexpected or harmful reactions in animals after using a veterinary medicine
  • Lack of expected effect of a veterinary medicine, even if used correctly
  • Environmental incidents linked to the use of a veterinary medicine
  • Harmful reactions in humans exposed to a veterinary medicine<
  • Residue levels in food products that exceed legal limits, even after the withdrawal period
  • Suspected transmission of infectious agents through a veterinary medicine
  • Reactions in animals after using a medicine intended for humans

When reporting in Eudravigilance, you must indicate if the product used in an animal was authorised for human use. Include (H) after the product name (e.g. Aspirin (H)). Consult the guidance in section 2.2 of EudraVigilance Veterinary – Best practice guide EMA/371192/2021 – Rev.12.

Working with third parties

If an MAH has contractual agreements with a third party, you must have explicit procedures and detailed agreements in place to ensure that suspected adverse events are collected and recorded in the Union Pharmacovigilance Database in accordance with the law.

Where can I find further guidance?

Further information and guidance can be found in:

Reporting special import cases

If you receive an adverse event report related to a product imported into Ireland under a special import licence, you must report it to the Department of Agriculture, Food and the Marine. You can do this by emailing info@agriculture.gov.ie or by telephone on 1890 200 510.