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Australian sites manufacturing finished veterinary chemical products (or intermediates) for export must be licensed and may need to provide the destination country’s regulator with evidence of Good Manufacturing Practice (GMP) compliance. This includes those manufacturing for export only.
This is because many countries seek similar assurances about imported products as Australia does. For example, their regulators want to be confident the manufacturing site is appropriately licensed, regularly audited and complies with particular standards.
1. Certificates of export
The Australian Pesticides and Veterinary Medicines Authority (APVMA) assists Australian manufacturers of veterinary chemical products seeking to export their goods by issuing certificates of export.
There are 3 main types of certificates issued by the APVMA to confirm a sites compliance with Australian GMP requirements:
- Certificates of GMP compliance issued under the mutual recognition agreement (MRA) between the European Community (EC) and Australia.
- Certificates of export and manufacture (Approved GMP).
- Certificates issued under section 70 of the Administration Act.
Manufacturers need to apply to the APVMA for an export certificate.
2. Exporting to Europe under the MRA
Some Australian veterinary chemical manufacturers exporting to Europe may be able to provide an APVMA-issued certificate of GMP compliance – instead of a certificate of export – to the destination country’s regulator.
Under the MRA, some European countries will accept Australian issued certificates of conformity as evidence of GMP compliance.
This is because Australia shares an MRA with the EC and the European Free Trade Association (EFTA) which includes Iceland, Liechtenstein and Norway.
Obtaining a certificate of GMP compliance
Under the MRA, the EC recognises the Therapeutic Goods Administration (TGA) as the authority for inspecting premises in Australia, with the APVMA recognised as the authority for issuing certificates.
This means Australian veterinary chemical manufacturers exporting to Europe under the MRA need to have their site inspected by the TGA, against the TGA’s Code of GMP. After the inspection, the manufacturer needs to provide the TGA’s inspection results to the APVMA with an application for a Certificate of GMP Compliance of a Manufacturer.
The APVMA will assess the TGA audit results and, based on the findings, may issue a certificate to the manufacturer.