Recognition of overseas GMP authorities

The APVMA has a Mutual Recognition Agreement (MRA) with regulators in many countries in Europe. The APVMA also recognises authorities in New Zealand, Canada and the United States as having requirements equivalent to the APVMA’s manufacturing standards.

This means the APVMA and the foreign regulatory authority have an agreement to recognise each other’s Certificates of GMP Compliance, audit reports and/or manufacturing licences. For some overseas manufacturers, this means the APVMA will consider these types of information—from one of these regulators—as acceptable evidence of their GMP compliance.

1. European-Australian Mutual Recognition Agreement (MRA)

Australia has a mutual recognition agreement (MRA) with the European Community (EC) and the European Free Trade Association (EFTA) which includes Iceland, Liechtenstein and Norway. The MRA covers conformity assessments for veterinary chemical products.

As different legislative and regulatory requirements apply among MRA partners, the MRA does not create a direct equivalence between Australian and EC regulations. Rather, the MRA allows for mutual recognition of test results and other conformity assessment documentation, including certification.

The EC MRA allows EC member states and Australia to recognise certificates of conformity (such as GMP certificates) issued by each other’s authorities. This means the MRA allows conformity assessments and inspections to be carried out in the country of manufacture, using their own rules and regulations.

The countries currently recognised by the EC and EFTA MRA are:

Austria Belgium
Denmark Finland
France Germany
Greece Iceland
Ireland Italy
Liechtenstein Luxembourg
Netherlands Norway
Portugal Spain
Sweden United Kingdom
Switzerland  

1.1. Importing products from Europe to Australia

The APVMA will accept a Certificate of GMP Compliance issued by a recognised authority in an MRA partner country.

The certificate can be downloaded from the European Union Drug Regulatory Authorities (EUDRA) GMP database. A printout of the certificate must be provided to us for verification. If the manufacturing site is not listed on the EUDRA GMP database, then a traditional Certificate of GMP Compliance of a Manufacturer will need to be provided.

The scope of the MRA does not cover audits by recognised EC authorities outside their own countries. However, such audits may be considered on a case-by-case basis.

1.2. Exporting products from Australia to Europe

Australian licence holders seeking to export products into the European Union can submit an application to the APVMA for a Certificate of GMP Compliance of a Manufacturer.

The application to export products to an EC or EFTA country can be made under the provisions of the MRA between Australia and the EC. This applies to both intermediate and finished veterinary chemical products manufactured in Australia.

A request for a Certificate of GMP Compliance of a Manufacturer relating to an Australian manufacturer should be made to the APVMA.

To obtain a certificate issued under the EC MRA, licence holders must then undergo an inspection by the Therapeutic Goods Administration (TGA) against the TGA’s Code of GMP. This is due to the EC recognising the TGA as the authority for inspecting veterinary chemical product manufacturing sites in Australia.

After the inspection, the APVMA will assess the results and, based on the findings in the report, may issue a certificate. Under the terms of the MRA, the EC recognises the APVMA as the authority to issue certificates and assist the manufacturer to coordinate the process.

2. Memorandum of Understanding (MOU) with New Zealand

The APVMA has an MOU with the New Zealand Ministry for Primary Industries’ Agricultural Compounds and Veterinary Medicines Group.

This means both the Australian and New Zealand regulatory bodies recognise certificates of GMP compliance issued by their counterparts. For manufacturers in New Zealand, this means they can submit the New Zealand certificate to the APVMA as evidence of GMP.

3. Recognition of evidence from Canada and the United States

The APVMA recognises certain authorities in Canada and the United States as having GMP compliance requirements equivalent to Australia’s for particular product types. Acceptable evidence is:

  • a current and acceptable certificate of GMP compliance
  • a licence and/or audit report from a recognised authority.

4. Other countries

No authorities are currently recognised in countries other than those listed above. For veterinary chemical product manufacturers in other countries, other types evidence may be recognised by the APVMA.

Where manufacture is in a country with which Australia does not have an MRA—or whose regulatory program is not recognised by the APVMA—the acceptable evidence of GMP compliance might include:

In some instances, we will also recognise audit reports from competent authorities that are members of the Pharmaceutical Inspection Convention/Cooperation Scheme (PIC/S).

In some instances, we will also recognise audit reports from competent authorities that are members of the Pharmaceutical Inspection Convention/Cooperation Scheme (PIC/S).

For guidance on the objective evidence required in such instances, manufacturers can contact the APVMA well before lodging an application for product registration. This guidance would be provided as pre-application assistance—though would not be eligible for a rebate.

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