The New Zealand Ministry for Primary Industries (MPI) Agricultural Compounds and Veterinary Medicines (ACVM) and the Australian Pesticides and Veterinary Medicines Authority (APVMA) allow the harmonisation of labels for veterinary medicines registered in both countries.
The ability to market products with harmonised labels provides a benefit to registrants with products registered in New Zealand and Australia, enabling sale and marketing of veterinary medicines with one common label in both countries.
The MPI ACVM guidance document Labelling Veterinary Medicines sets out the rules for how harmonised labels can be formatted, and what content can be included, for products registered in New Zealand. Harmonised labels are usually formatted as per APVMA requirements, with a New Zealand information box or section included to provide regulatory statements and other content required by the ACVM Act.
Harmonised labels intended for marketing products in both New Zealand and Australia 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. This means the content in the main part of the label, written to comply with the Australian requirements, must align with the label content approved for the New Zealand registration, other than content clearly identified as New Zealand-specific information.
The reverse will also be true: New Zealand-specific information must not contradict, confuse, appear misleading or deceptive, or affect the meaning of the relevant particulars approved by the APVMA.
Please note that 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.
Examples of harmonised labels
There are different eligibility criteria, depending on the labelling requirements of both countries, where registrants of veterinary medicines can obtain a harmonised label for use in New Zealand and Australia.
Example 1: approved
A companion animal anthelmintic medicine is registered in both countries, though there are claims for target parasites in Australia that are not relevant to New Zealand. A harmonised label will require a statement in the New Zealand information box or section identifying the parasites from the Australian part of the label that are not present in New Zealand, e.g. heartworm.
With this statement, the product can be approved with a harmonised label by the ACVM.
Example 2: approved
A veterinary medicine is registered as a restricted veterinary medicine (RVM) in New Zealand, and as a prescription animal remedy in Australia. While these are different designations, they both identify the product as requiring veterinary authorisation before sale and use and therefore do not conflict.
The product can be approved with a harmonised label by the ACVM.
Example 3: unapproved
A veterinary medicine is registered as a RVM in New Zealand but is authorised as an over-the-counter medicine in Australia. This difference in prescription status presents a conflict with respect to risk management and may cause confusion regarding authorisation requirements and product availability in both Australia and New Zealand.
Because this conflict is inherent to the regulatory approvals and cannot be resolved with a change in label content, the product cannot be approved with a harmonised label by the ACVM.
Example 4: unapproved
A veterinary medicine is registered for use in horses, requiring a withholding period (WHP) in both countries. If the approved meat WHP significantly differs in Australia and New Zealand, or one authority prohibits use in food producing animals while the other allows for a WHP, then the labels are considered conflicting, and the product cannot be approved with a harmonised label by the ACVM.
Where a default WHP has been applied in both regions, registrants may contact both agencies to see if a single WHP is acceptable to both ACVM and APVMA. Typically, this will be the most conservative WHP.
Example 5: unapproved
A veterinary medicine is registered for use in cats with a statement that has been determined as a contraindication statement by the APVMA and a precautions statement by the ACVM.
As the instructions of use are considered conflicting, the product cannot be approved with a harmonised label.
In such cases, registrants may contact both agencies to have a harmonised label that captures the best statement under the same label heading.