Why veterinary medicine labels may change
Differences between animal breeds and individuals makes it difficult for the information gathered to support the registration of a veterinary medicine to investigate all possible use scenarios or identify all possible adverse outcomes.
Post-registration adverse event reporting and new information arising from other sources may identify issues related to the safety, efficacy, or residue profile of a veterinary medicine that were not detected before registration.
This new information may prompt the need for changes to the product’s approved label content.
In addition, one of the risks managed under the ACVM Act is risks to trade. Where changes to the way products can be used are required to ensure New Zealand exported primary produce can continue to be sold overseas there will be label content changes.
It may take up to 12 months for product bearing the amended label to be available for sale. Whilst the label content on the ACVM Register will be updated immediately, for ease of reference all risk management changes will also be recorded on our Post-Registration Risk Management Label Change Summary. You can check our label summary document to find out what's changed for particular products.
Post-registration risk management label change summary [XLSX, 72 KB]
The full currently approved label content for all registered products is available in the ACVM register.
Adverse events
All adverse events should be reported directly to the registrant of the product and/or the Ministry for Primary Industries (MPI).
Subscribe for updates
Updates to the register can be sent direct to your inbox by email. Visit the Subscribe to MPI page and select 'Pharmacovigilance label update register for veterinary medicines' under email topics.
