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.
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 site's compliance with Australian GMP requirements:
- Certificates of GMP compliance issued under the mutual recognition agreement (MRA) between the European Community (EC), European Free Trade Association (EFTA) or United Kingdom (UK), and Australia.
- Certificates of export and manufacture (Approved GMP) issued under section 69D of the Administration Act.
- Certificates issued under section 70 of the Administration Act.
Manufacturers need to apply to the APVMA for an export certificate.
Exporting to Europe under the MRA
Some Australian veterinary chemical manufacturers exporting to Europe and the United Kingdom 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:
- European Community (EC)
- European Free Trade Association (EFTA), which includes Iceland, Liechtenstein and Norway
- United Kingdom, which includes Great Britain and Northern Ireland.
Obtaining a certificate of GMP compliance
Under the MRA, the Therapeutic Goods Administration (TGA) is recognised 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 under the MRA need to have their site inspected by the TGA, against the TGA’s Code of GMP.
The manufacturer needs to submit a request for a Certificate of GMP Compliance (FM_MQL39) to the APVMA. We will then lodge a Certificate Application with the TGA on behalf of the manufacturer.
The TGA will directly notify the manufacturer of the inspection date. Once the inspection has been completed and closed by the TGA, a copy of the inspection reports needs to be provided to the APVMA for review. We will assess the TGA audit results and, based on the findings, may issue a certificate to the manufacturer.