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Draft facility standard for biological products

Have your say

From 19 December 2019 to 14 February 2020 the Ministry for Primary Industries (MPI) invites comment on proposed changes to the facility standard for biological products.

Changes to the facility standard include:

  • movement of the facility standard from prescriptive to outcome-based requirements
  • guidance boxes
  • removal of reference to the Australian/New Zealand Standard 2243.3 – Safety in laboratories, Part 3: Microbiological safety and containment (AS/NZS 2243.3). In its place, the requirement for a biosafety risk assessment has been added to the draft proposed facility standard.

Consultation document

Facility Standard: Biological Products [PDF, 954 KB]

Making your submission

Email your feedback on the draft by 5pm on 14 February 2020 to

Make sure you include in your submission:

  • the title of the consultation document in the subject line of your email
  • your name and title, if applicable
  • your organisation's name (if you're submitting on behalf of an organisation)
  • your contact details (for example, phone number, address and email).

While we prefer email, you can send your submission by post to:

Biological Products Facility Standard Consultation, Animal Imports
Ministry for Primary Industries
PO Box 2526
Wellington 6140
New Zealand.

All submissions received by the closing date will be considered before the amended facility standard is issued. MPI may hold late submissions on file for consideration when the issued facility standard is next revised or reviewed.

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.