Manufacturing veterinary medicines under the ACVM Act 1997

You must be approved under the Agricultural Compounds and Veterinary Medicines (ACVM) Act 1997 if you want to manufacture registered veterinary medicines in New Zealand. You must also follow Good Manufacturing Practice (GMP).

What manufacturing includes

Manufacturing, under the ACVM Act 1997, includes any of the following steps in production of veterinary medicines:

  • getting materials
  • preparing
  • producing
  • processing
  • assessing and testing (including contract laboratory testing)
  • filling, packing and labelling in a container for sale
  • sterilisation.

Manufacturing exempt-from-registration veterinary medicines

If you're manufacturing veterinary medicines that are exempt from registration in New Zealand, we expect you to:

  • operate under a documented system for all manufacturing steps (including quality control and market release)
  • make sure your product is fit for purpose and meets product/manufacturing specifications
  • comply with the conditions of the exemption.

Exempt from registration: veterinary medicines and conditions

Exporting veterinary medicines exempt from registration

If you want to export an exempt product, and require evidence of Good Manufacturing Practice (GMP) compliance, check with the importing country to see if they'll accept an MPI-issued certificate of GMP compliance.

Apply for an MPI Good Manufacturing Practice (GMP) compliance assessment 

Manufacturing registered vet medicines

Manufacturers of ACVM registered veterinary medicines must comply with Good Manufacturing Practice (GMP).

  • New Zealand manufacturers are inspected/audited to make sure they comply with the ACVM Standard and Guideline for GMP.
  • International manufacturers can be assessed under equivalent standards or under MPI's GMP programme.

You must have approval from one of the following:

  • MPI
  • Medsafe – MPI will accept Medsafe approval (for facilities that also manufacture human medicines) as long as veterinary medicines are covered in their audit
  • a Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme member
  • a recognised agency under the European Union Mutual Recognition Agreement
  • a recognised agency with a technical agreement with MPI.

Overseas veterinary medicine manufacturers: evidence of Good Manufacturing Practice (GMP)

Overseas manufacturers can be assessed by other organisations for GMP or equivalent standards. You'll need to provide evidence of GMP when you apply to register a veterinary medicine (or vary a registration).

Evidence of current GMP compliance must be issued by an agency that:

  • is a Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme (PIC/S) member, or
  • is a European Mutual Recognition Agreement (MRA) partner, or
  • has a technical agreement with MPI.

Your GMP certificate, license, or equivalent evidence must show the:

  • full name of the manufacturer
  • address of the premises
  • scope of functions (or products) included in the approval
  • date of the last inspection or certificate expiry.

If the certificate or license doesn't show how long it's valid for, the date of issue or last inspection must be within the last 3 years. You may need to provide a recent audit report or successful audit completion letter as evidence with the license.

If you can't provide evidence of current GMP compliance this way, you'll need to apply for MPI approval.

Getting MPI approval to manufacture veterinary medicine

New Zealand manufacturers (and overseas manufacturers who want MPI GMP approval), must

  • have an MPI-approved operating plan
  • apply to MPI for approval as a manufacturer
  • comply with the ACVM Standard and Guideline for GMP.

Develop your operating plan

An operating plan includes the quality system, documents and procedures used to:

  • control the manufacturing process
  • comply with the conditions of registration for your products.

Follow our guidelines to develop your operating plan.

Operating plan guidelines [PDF, 126 KB]

Apply for MPI veterinary medicine manufacturer approval

To get approved by MPI as a manufacturer, or change your scope of approval, complete the Application for approval to manufacture veterinary medicines form and email to the address on the form.

Approval to manufacture veterinary medicines or vertebrate toxic agents (VTA): Application form ACVM 18 [DOC, 455 KB]

The application form asks you to provide a site master file. For help preparing this, read the Pharmaceutical Inspection Cooperation Scheme's guidance:

Site master file: how to prepare it

Good Manufacturing Practice (GMP) compliance audit

After we get your application, an ACVM auditor will contact you to arrange a site audit to check compliance against the:

If your operating plan complies, the premises will be issued with a certificate of compliance and added to our list of approved manufacturers. Your site will be audited regularly to make sure it continues to comply.

Approved veterinary medicine and vertebrate toxic agent (VTA) manufacturers list

Fees

You'll need to pay any costs involved with auditing and approvals, including travel and expenses.

Fees for MPI's ACVM services [PDF, 186 KB] 

Change a Good Manufacturing Practice (GMP) certificate

Name change

To change a name on a GMP certificate issued by MPI, submit a completed GMP certificate: Request for name change form.

Address, facility, or scope of approval change

To change a manufacturer's address, facility, or scope of approval, you'll need to submit an Application for approval to manufacture veterinary medicines form. You may need an audit before these changes are approved.

Approval (or change to approval) to manufacture veterinary medicines application - Form ACVM 18 [DOC, 455 KB]

Extra copies of GMP certificates

To get extra copies of MPI-issued GMP certificates, submit a completed GMP certificate: Request for additional copies form.

Manufacturing veterinary medicines for export

You must keep veterinary medicines for export separated from products registered for New Zealand use – their requirements are different.

To export veterinary medicines, you may need to meet certification requirements for the importing country.

About export certification

If you require evidence of GMP compliance for your exported product, follow the MPI approval process.

Good Manufacturing Practice (GMP) approval from MPI

Batch certificate for veterinary medicines required by some countries

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 is in addition to a full analysis of all active and other relevant ingredients in your product.

The batch certificate must state that the batch meets specifications and has been manufactured in accordance with the marketing authorisation of the destination country. The certificate must provide:

  • specifications of the product
  • methods used to analyse the product
  • results of analysis
  • a statement that the batch processing and packaging quality-control records conform with GMP
  • signature of the person who released the batch at the manufacturing site.
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