Our role in vaccine approving the vaccines used in Aotearoa New Zealand is limited.
If a vaccine contains a new organism or a genetically modified organism (GMO), it must be approved by us.
Determining if the vaccine contains a new organism
- We can determine whether a vaccine contains a new organism or a GMO, but only if a manufacturer or importer of the vaccine asks us or if they are directed to do so by the Ministry for Primary Industries (MPI).
- If a vaccine contains a new organism, including a GMO, then the manufacturer or the importer must get an approval from us before it can be used in New Zealand. We assess the risks versus benefits of releasing a new organism vaccine into New Zealand’s environment.
We do not assess its chemical properties
- Human medicines are exempt from the hazardous substances part of the Hazardous Substances and New Organisms Act 1996 – which we administer – so we do not assess a vaccine’s chemical properties.
- We rely upon the information provided to us by manufacturers and do not conduct a chemical analysis of the product.
A manufacturer or importer may still be subject to standard import and compliance requirements from MPI.