Adverse Experience Reporting Program for Veterinary Medicines

What to do if you or an animal in your care has been adversely affected by a registered veterinary medicine

  • if you have been affected seek immediate medical advice
  • if your animal has been affected seek immediate veterinary advice
  • call the contact number on the product label and report your adverse experience to the registration holder
  • keep any remaining product in a safe place in case a sample is required by the registration holder
  • contact the APVMA to report the incident, but please note that the APVMA does not provide medical or veterinary advice.

Definition of an adverse experience

The following definition of an adverse experience is to be used by product registration holders when determining what information should be submitted to us. An adverse experience is:

An unintended or unexpected effect on animals, human beings or the environment, or lack of efficacy associated with the use of a registered veterinary chemical product when used according to label instructions.

Definition of a serious adverse experience

A serious adverse experience involving veterinary medicines is expected to be reported to the APVMA by the product registration holders as soon as the registration holder becomes aware of the information. A serious adverse experience is:

Any adverse experience that results in death, is life-threatening, results in persistent or significant disability or incapacity, prolonged duration of serious signs or is a congenital abnormality or birth defect in animals. A serious adverse experience in humans is one that requires medical treatment or involves death.

If there is any doubt about the seriousness of a suspected adverse experience, the incident must be treated as a serious adverse experience and reported by the registration holder to the APVMA as soon as possible.

The following provides a quick guide to determine if an adverse experience is to be regarded as serious.

Humans

  • death
  • medical treatment required.

Cattle, sheep and pigs

  • death
  • more than one veterinary visit
  • more than 10 per cent morbidity
  • welfare implications.

Horses

  • death
  • hospitalisation or more than one veterinary visit
  • welfare implications.

Poultry

  • more than 5 per cent increase in base mortality
  • more than 10 per cent morbidity
  • welfare implications.

Small animals

  • death
  • hospitalisation
  • welfare implications.

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