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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 and manufacturing specifications
  • comply with the conditions of the exemption.

Find out more about veterinary medicines exempt from ACVM registration

Exporting veterinary medicines exempt from registration

If you want to export an exempt product, and require evidence of 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 GMP.

  • New Zealand manufacturers are inspected or 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
  • 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 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.

The Mutual Recognition Agreement – MBIE

Pharmaceutical Inspection Cooperation Scheme

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, complete the ACVM 39 application form.

Application for approval to manufacture veterinary medicines, vertebrate toxic agents, and exempt products for export: ACVM 39 [DOCX, 318 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 – Pharmaceutical Inspection Co-operation Scheme

The application form asks you to specify the scope of activities you request to be included in your GMP approval. For assistance in selecting the appropriate categories, and understanding the definitions, refer to the following guidance:

ACVM-Issued Good Manufacturing Practice (GMP) Certificate of Compliance Category Guideline [PDF, 255 KB]

GMP compliance audit and GMP certification

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 manufacturers

The following guideline provides information on the scope and categories specified on MPI-issued GMP Certificates of Compliance:

ACVM-Issued Good Manufacturing Practice (GMP) Certificate of Compliance Category Guideline [PDF, 255 KB]

Fees

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

Fees for MPI's ACVM services [DOCX, 76 KB] 

Apply for a variation to a Good Manufacturing Practice (GMP) certificate or approved site

Address, facility, or scope of approval change

To apply for a change to a manufacturer's address, facility, or scope of approval, complete the ACVM 71 application form: 

Application to vary approval to manufacture veterinary medicines, vertebrate toxic agents, and exempt products for export – ACVM 71 [DOCX, 126 KB]

You may need an audit before these changes are approved.

Extra copies of GMP certificates

To get extra copies of MPI-issued GMP certificates, complete the ACVM 19 application form:

GMP certificates: Request for additional copies – ACVM 19 [DOCX, 995 KB]

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.

Who to contact

If you have questions about veterinary medicines, email approvals@mpi.govt.nz

MPI business units