Manufacturing for export
Export-only veterinary medicines must be kept separate from New Zealand-registered products and may have to meet certification requirements. Learn more about requirements and certification.
No ACVM (Agricultural Compounds and Veterinary Medicines) legislation requirements apply for export-only veterinary medicines, but export-only products must be kept separate from New Zealand registered products.
If you want to export veterinary medicines, you may need to meet certification requirements for the importing country.
If you are manufacturing veterinary medicines for export to a Mutual Recognition Agreement (MRA) country (Australia, Canada, European Community and Switzerland), you must issue a batch certificate to accompany each batch. This certificate is in addition to a full qualitative and quantitative analysis of all active and other relevant constituents.
The batch certificate must attest that the batch meets the specifications and has been manufactured in accordance with the marketing authorisation of the importing country, detailing the specifications of the product, the analytical methods referenced, and the analytical results obtained. It must contain a statement that the batch processing and packaging quality control records conform with good manufacturing practice. It must be signed by the person responsible for releasing the batch for sale or supply/export at the fabrication/manufacturing site.
Has this been useful? Give us your feedback