Manufacturing licences

Manufacturers of veterinary chemical products in Australia must be appropriately licensed by the APVMA. This applies to anyone in Australia involved in any step of manufacture of a veterinary chemical product, unless specifically exempt.

Manufacturers must apply to the APVMA to obtain a licence—or to vary an existing one—before performing any step of manufacture. The APVMA must be satisfied the applicant’s site of manufacture is suitable and complies with Good Manufacturing Practice (GMP). It must also be satisfied the manufacturer will be able to comply with licence conditions and the Manufacturing Principles.

The APVMA does not have jurisdiction to license overseas manufacturers. However, registrants and applicants of veterinary chemical products must provide evidence of overseas GMP compliance before a product can be registered and supplied in Australia.

Manufacturers’ Licensing Scheme

The APVMA administers the Manufacturers’ Licensing Scheme to manage the issue of licences to Australian based manufacturing sites.

Applying for a manufacturing licence

Important information manufacturers need to know before starting an application for a manufacturing licence.

Who can apply

Who can—and must—apply for a veterinary chemical manufacturing licence or to vary an existing one.

Manufacturing licence fees

Information about application fees—and the ongoing fees for existing licence holders.

Licence conditions

Licences to manufacture veterinary chemical products in Australia are issued with specific licence conditions.

After you apply

What happens after an application is submitted to the APVMA.

Variation of a manufacturing licence

Information current licence holders need to know about varying their licence to manufacture veterinary chemical products in Australia.

Audits to obtain and vary a licence

An audit may be required to inspect the premises, equipment, processes and facilities proposed to be used in the manufacture of a veterinary chemical product.

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