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Draft import health standard (IHS) for biological products

Updated – 17 December 2021

Final documents released

Import Health Standard: Biological products [PDF, 419 KB]

Guidance document: Biological products [PDF, 331 KB]

Risk Management Proposal: Biological Products [PDF, 314 KB]

Updated – 19 November 2021

Provisional documents released

Import Health Standard: Biological products [PDF, 492 KB]

Guidance document: Biological products [PDF, 374 KB]

Risk management proposal: Biological products [PDF, 369 KB]

Review of submissions [PDF, 2.5 MB]

Have your say

From 21 November 2019 to 31 January 2020, the Ministry for Primary Industries (MPI) invited comment on proposed changes to the import health standard for biological products.

Full details of the proposed changes are in the consultation documents.

Consultation documents

Draft Import Health Standard: Biological products [PDF, 856 KB]

Draft Guidance Document: Biological products [PDF, 726 KB]

Draft Risk Management Proposal: Biological products [PDF, 546 KB]

Related document

WTO notification [PDF, 112 KB]

Steps to finalising the new IHS

After consultation on a draft import health standard, MPI publishes a provisional IHS.

If you made a submission during the consultation, you have 10 working days to notify the director-general of MPI that you intend to request an independent review. Reviews are limited to whether or not specific scientific evidence was given sufficient consideration.

If no review is requested within 10 working days, then the provisional IHS is confirmed and issued as a standard.

For more information about reviews refer to Section 24 of the Biosecurity Act 1993 (NZ Legislation)

Submissions are public information

Note that any submission you make becomes public information. People can ask for copies of submissions under the Official Information Act 1982 (OIA). The OIA says we have to make submissions available unless we have a good reason for withholding it.  That is explained in sections 6 and 9 of the OIA.

Tell us if you think there are grounds to withhold specific information in your submission. Reasons might include that it's commercially sensitive or it's personal information. However, any decision MPI makes to withhold information can be reviewed by the Ombudsman, who may tell us to release it.

Legal background

MPI must consult with interested parties in accordance with section 23 of the Biosecurity Act 1993 (the Act) and MPI's consultation policy before issuing or amending (other than of minor or urgent nature) import health standards (IHS) under sections 24A and 24B of the Act.

An IHS specifies import requirements that must be met either in the country of origin or of export, or during transit before biosecurity clearance can be given for the goods to enter New Zealand. MPI must ensure that these requirements are technically justified and provide an appropriate level of biosecurity protection.