Report a non-compliant registered ACVM product or associated activity

Use our online form to report a potentially non-compliant ACVM registered product or activity you've purchased or seen advertised and/or sold in New Zealand.

Online form: Report a suspected non-compliant ACVM product or activity

Note: if you have used a product and something has gone wrong or is unexpected, this may be considered an adverse event.

Find out about ACVM adverse events

All reports of suspected non-compliance are prioritised for action based on the level of risk to one or more matters referred to in section 4 of the ACVM Act.

How we look into reports about non-compliant ACVM products

Notifying MPI

MPI expects to be notified of the non-compliance, risk assessment, and actions taken or proposed including product recalls as soon as possible.

A registrant (or other authorised entity) might become aware of a product or batches that have been released to the New Zealand market and does not comply with conditions of registration.

The registrant is required to notify MPI as soon as they become aware of an issue.

• If the non-compliance could pose a serious or significant risk, it should be reported to MPI immediately within 1 working day after becoming aware of an issue.
• All other non-compliances should be reported to MPI within 3 working days after becoming aware of an issue.

We have guidance to help you provide the information we need to do our risk assessment and review of the non-compliance. Use our form to submit your report (including risk assessment):

Non-Compliance Report: Notification of your non-complying ACVM registered product on the market [DOCX, 396 KB]

Guideline for Registrants: Reporting your non-complying ACVM registered product on the market [PDF, 452 KB]

If a recall is proposed, also complete the recall form and use the guidance to assist.

ACVM product recall notification form [DOCX, 384 KB]

Guideline for conducting recalls of ACVM products [PDF, 450 KB]

Point of sale and communications example templates

Letter notifying distribution channels of a recall [DOCX, 51 KB]

Recall acknowledgement form [DOCX, 36 KB]

Recall point of sale notice template [DOCX, 340 KB]

How to submit your report

Email the forms and your risk assessment to ACVM-recallsandcompliance@mpi.govt.nz

Provide as much information as possible. If all information cannot be provided right away, tell us when to expect further information.

Next steps after we get your report

We will review and consider the non-compliance, proposed actions, and associated risks under the ACVM Act. If we do not have enough information (such as details of a thorough risk assessment) or the actions taken or proposed do not manage or mitigate the risks, we may need to take further regulatory action.

In exceptional circumstances, you may request a batch specific variation (BSV) for consideration on a case-by-case basis if:

• a non-compliance is identified in batches of an ACVM registered product that has yet to be released to the New Zealand market
• rework is not viable
• the non-compliance is not considered to negatively impact the risk profile of the product.

A BSV is not intended to:

• facilitate a permanent change
• be used as a temporary measure when a permanent and/or product-wide change is required urgently
• circumvent, replace, or fast-track the variation application process.

Allow enough time for a variation application to be processed and approved before making the change.

Submit any permanent product-wide variation applications to approvals@mpi.govt.nz

A BSV will likely be declined if:

• a BSV is requested for the same reason as a variation application already in the queue or for a change that will become permanent
• it becomes apparent that the batches do not meet HSNO or biosecurity approval for the product.

How to request a BSV

Use our form to submit your BSV request. Complete the form in full and provide all relevant supporting information. Your request may not be accepted for assessment if the form is not fully completed.

Batch Specific Variation (BSV): Request to release your non-complying batch of an ACVM registered product [DOCX, 379 KB]

Guideline for registrants: Requesting to release your non-complying batch of ACVM registered product (batch specific variation – BSV) [PDF, 320 KB]

Email the form to ACVM-recallsandcompliance@mpi.govt.nz