Report a non-compliant registered ACVM product or associated activity

Find out how to report a suspected or known non-compliant ACVM registered product or activity.

What is a registered ACVM product?

An ACVM registered product must be manufactured, imported, sold, and used in accordance with the conditions imposed on its registration under section 23 of the Agricultural Compounds and Veterinary Medicines (ACVM) Act 1997.

If a condition of registration has requirements related to activities such as importing, manufacturing, distribution, sale, or use, the party responsible for carrying out that activity must also comply with the relevant condition.

Our ACVM register has the conditions of registration for each registered product:

Report a suspected non-compliant ACVM registered product or activity

Use this form to report a potentially non-compliant ACVM registered product or associated activity:

Report a suspected non-compliant ACVM product or activity [DOCX, 476 KB]

Note: if you have used a product and something has gone wrong, this may be considered an adverse event (AER).

Read more about adverse events with ACVMs

All reports of suspected non-compliance are prioritised for action based on risk. Risk is based on the potential (or actual) harm to people, animals, the environment, and trade.

Read more about how we look into reports about non-compliant ACVM products

Report a non-conformance with your ACVM registered product or activity (registrant or other authorised entity only)

ACVM registered product already released to market

A registrant (or other authorised entity) might become aware of a product or batches that has been released to the New Zealand market and does not conform to the expected quality standard or conditions of registration

The registrant is required to notify MPI as soon as they become aware of the problem:

  • If the non-conformance could pose a serious risk, the non-conformance should be reported to MPI immediately within 1 working day after becoming aware of an issue.
  • All other non-conformances 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-conformance. Use our form to submit your report (including risk assessment):

Non-Conformance Report: Notification of a nonconforming ACVM registered product on the market [DOCX, 498 KB]

Guideline for Registrants: Reporting non-conforming ACVM registered product on the market [PDF, 439 KB]

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

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

We will review and consider the non-conformance, proposed actions and associated risks. If we do not have enough information (such as details of a thorough risk assessment) or the actions taken or proposed do not mitigate the risks, we may take regulatory action such as a directed recall.

ACVM registered product not yet released to market

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

  • a non-conformance 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-conformance is not considered to negatively impact the risk profile of the product.

A BSV is not intended to:

  • facilitate a permanent change, or
  • be used as a temporary measure when a permanent and/or product-wide change is required urgently.

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

Any permanent product-wide variation applications should be submitted to approvals@mpi.govt.nz

How to request a BSV

Requests for a BSV should be submitted using the BSV request form. The form should be completed in full and all relevant supporting information provided. If the form is not fully completed, the request will not be accepted for assessment.

Batch Specific Variation (BSV): Request to release a non-conforming batch of an ACVM registered product [DOCX, 422 KB]

Guideline for Registrants: Requesting to release a non-conforming batch of ACVM registered product (Batch Specific Variation - BSV) [PDF, 367 KB]

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

Who to contact

If you have questions about ACVM non-compliance, email ACVM-recallsandcompliance@mpi.govt.nz

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