The New Zealand Ministry for Primary Industries (MPI) Agricultural Compounds and Veterinary Medicines (ACVM) and the Australian Pesticides and Veterinary Medicines Authority (APVMA) allow harmonised labels for veterinary medicines registered in both countries.
Registrants of veterinary medicine products registered in both New Zealand and Australia can benefit from one common label to sell and market in both countries.
Guidance has been issued to clarify the harmonised labelling requirements for industry.
Harmonised labels must be formatted in line with APVMA requirements, with a separate section on the label to provide regulatory statements and other specific content required by New Zealand’s ACVM Act.
Harmonised labels can be considered if the Australia-specific information regarding the claims and use of the product do not jeopardise the risk areas managed under the ACVM Act.
The main part of the label must be written to comply with both the Australian and New Zealand requirements for registration, other than content clearly identified as New Zealand-specific information.
Additionally, New Zealand-specific information must not contradict, confuse, appear misleading or deceptive, or affect the meaning of the relevant particulars approved by the APVMA.
The APVMA does not approve marketed labels, therefore harmonised labels must not be submitted to the APVMA for approval. Marketed labels must comply with the requirements of the Veterinary Labelling Code and other statutory conditions.
More information
APVMA
Website: apvma.gov.au
Enquiries: +61 2 6770 2300 | enquiries@apvma.gov.au
Media: +61 2 6770 2402 | media@apvma.gov.au
MPI ACVM
Website: https://www.mpi.govt.nz/agriculture/agricultural-compounds-vet-medicines/
Enquiries: mpi.approvals@mpi.govt.nz
Media: +64 29 894 0328 | media@mpi.govt.nz