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).
On this page:
- What manufacturing includes
- Manufacturing exempt-from-registration veterinary medicines
- Manufacturing registered vet medicines
- Change a Good Manufacturing Practice (GMP) certificate
- Extra copies of GMP certificates
- Manufacturing veterinary medicines for export
Manufacturing, under the ACVM Act 1997, includes any of the following steps in production of veterinary medicines:
- getting materials
- assessing and testing (including contract laboratory testing)
- filling, packing and labelling in a container for sale
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.
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.
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:
- 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.
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.
The application form asks you to provide a site master file. For help preparing this, read the Pharmaceutical Inspection Cooperation Scheme's guidance:
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:
- Standard for ACVM Good Manufacturing Practice (GMP) [PDF, 70 KB]
- Guideline for ACVM Good Manufacturing Practice (GMP) [PDF, 202 KB]
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.
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]
To change a name on a GMP certificate issued by MPI, submit a completed GMP certificate: Request for name change form.
- Change name on a GMP certificate - Form ACVM 20 [PDF, 324 KB]
- Change name on a GMP certificate - Form ACVM 20 (Word document) [DOC, 995 KB]
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.
To get extra copies of MPI-issued GMP certificates, submit a completed GMP certificate: Request for additional copies form.
- Extra copy of GMP certificate request [PDF, 323 KB]
- Extra copy of GMP certificate request (Word document) [DOC, 988 KB]
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.
If you require evidence of GMP compliance for your exported product, follow the MPI approval process.
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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