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Adverse Event Reporting

 

What is an adverse event?

 

Definition as detailed by New Zealand Food Safety Authority:

A veterinary medicine "adverse event" is any observation in animals that is unfavourable and unintended, and that occurs after the use of a veterinary medicine.  This may include side effects, target animal safety issues, residue issues, lack of efficacy or alleged interactions with other products or compounds.  Note:  All unfavourable or unintended events that are recognised outcomes of product use and that may or may not be identified on the produce label are classified as adverse events.

As an organisation we have an obligation to record and advise NSFSA of all adverse event reports received within set timeframes.  Each report received is assessed and classified as Serious or Non-Serious.

 

 

What do I need to do to report and adverse event?

 

Complete an Adverse Event Report Form and send through to us either by fax or e-mail.  This form can be downloaded from the MPI website - ACVM Forms and Templates.

 

Please ensure you complete as much detail as possible on the form; the four essential elements required are: 

1.     Patient information

2.     Report name and contact details

3.     Product(s) administered

4.     Description of the event/reaction/symptoms and any subsequent treatment given

 

Please ensure the completed form is sent directly to Merial Ancare; we will notify the ACVM Group at NZFSA as per legal requirements.

 

If at any time you have questions or concerns, please do not hesitate to contact the Technical Services Team for assistance and advice on:

 

             FREEPHONE 0800 800 822

 

 

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