Adverse Reaction Reporting

An adverse reaction is a harmful and unintended (or unexpected) reaction to a veterinary medicine.

Adverse reactions are classified as either ‘serious’ or ‘non-serious’ depending on the clinical outcome.

Reactions are considered to be serious if they are:

  • fatal; 
  • life-threatening; 
  • disabling; 
  • incapacitating; 
  • permanent or result in prolonged symptoms in the animal treated; or 
  • a human adverse reaction to a veterinary medicine.

 

Why report a reaction?

Extensive testing is carried out on the safety and effectiveness of veterinary medicines before they are authorised for sale.  These studies can identify some common adverse reactions that an animal or a user may experience during or after treatment with the medicine. However, certain interactions as well as rare adverse reactions or reactions specific to certain breeds or groups of animals may only be identified when the product is used more widely. It is therefore important that all suspected adverse reactions or events are reported to us to enable us to monitor the unexpected reactions and to take action where necessary.

Who should report?

  • marketing authorisation holders (within 15 days if serious);
  • veterinary practitioner or a pharmacist*;
  • wholesalers*;
  • licensed merchants*;
  • members of the public (the advice of a vet should be sought if possible).

 

*National legislation (European Communities (Animal Remedies) (No. 2) Regulations 2007 [S.I. No. 786 of 2007]) requires that the holder of an animal remedies wholesaler’s licence, an animal remedies merchant’s licence, a registered veterinary practitioner or a pharmacist shall report to the

Board or the holder of the animal remedies authorisation, any suspected serious or unexpected adverse reaction or human adverse reaction which is reported to him or her, or which otherwise come to his or her attention. The report shall be made at the earliest opportunity and not later than 15 days following receipt of the information. “

How to report a reaction to the HPRA 

  • Report a suspected adverse reaction directly by filling in the online form.
  • downloadable version of the form is also available, which can be filled in manually and sent to the HPRA by e-mail or by freepost.

 

If you require any further information about reporting an adverse reaction to a veterinary medicine you can also contact the HPRA’s Veterinary Sciences Department on (01) 676 4971 or by emailing (vetsafety@hpra.ie).