Manufacturing veterinary medicines

Find out about the requirements you need to meet if you want to manufacture veterinary medicines. Under MPI's definition, manufacturers include repackers, relabellers, and contract testing laboratories.


Manufacturing exempt veterinary medicines

If you're manufacturing exempt veterinary medicines in New Zealand, we expect you to operate under a documented system for all manufacturing steps, including quality control and market release. You must ensure your product is fit for purpose and conforms to product/manufacturing specifications.

Manufacturing registered veterinary medicines

If you're manufacturing registered veterinary medicines in New Zealand, you must

  • have approval under the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme (PIC/S), including a current good manufacturing practice (GMP) certificate from a competent authority that is a PIC/S member or a Mutual Recognition Agreement (MRA) partner, or
  • have approval from MPI.

Approval under the Pharmaceutical Inspection Convention

New Zealand manufacturers of veterinary medicines are subject to GMP. For manufacturers not inspected by MPI, alternative methods have been developed through collaboration with other regulatory bodies and organisations to give assurance that a manufacturer is an acknowledged organisation and complies with GMP or an equivalent standard.

Recognition can be granted for manufacturers that have been approved by a regulatory authority. That regulatory authority must be a PIC/S member or MRA partner, or it must have a technical agreement with MPI. Supply a current GMP certificate that references the approved manufacturer, the audit scope, and the date of inspection or certificate expiry.

Find out more about preparing a manufacturer's site master file by downloading this PDF from the Pharmaceutical Inspection Co-operation Scheme website:

MPI approval

For MPI approval, you must have an operating plan approved under section 28 of the ACVM Act. Operating plan is the term used to define the quality system and collection of documents and procedures used to control the manufacturing process and comply with the conditions of registration for these products.

To become an approved manufacturer or change your scope of approval, complete this form:

To help you develop your operating plan, read

For more information, read

Manufacturing for export

There are no ACVM legislation requirements for export-only veterinary medicines, but export-only products must be kept separate from New Zealand-registered products.

If you want to export veterinary medicines, you may need to meet certification requirements for the importing country. For MPI's policy on this, read

If you're manufacturing veterinary medicines for export to a Mutual Recognition Agreement (MRA) country (Australia, Canada, European Community, or Switzerland), you must issue a batch certificate to accompany each batch. This certificate is in addition to a full qualitative and quantitative analysis of all active and other relevant constituents.

The batch certificate must attest that the batch meets the specifications and has been manufactured in accordance with the marketing authorisation of the importing country. The certificate must detail the specifications of the product, the analytical methods referenced, and the analytical results obtained.

It must also contain a statement that the batch processing and packaging quality-control records conform with GMP. It must be signed by the person responsible for releasing the batch for sale or supply/export at the fabrication/manufacturing site.

Certificate requests from MPI-approved GMP manufacturers

Approved manufacturers requesting additional copies of GMP certificates must complete and return this form:

Approved manufacturers requesting a name change on their GMP certificate must complete and return this form:

Changes to a manufacturer’s address, facility, or scope of approval must be formally approved. In these instances, a manufacturer must complete this application form: 

An audit may be required for the change to be approved.

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