Recognition of overseas GMP authorities

The Australian Pesticides and Veterinary Medicines Authority (APVMA) recognises authorities in Europe, including the United Kingdom, through Mutual Recognition Agreements (MRA). The APVMA also recognises authorities in New Zealand, Canada and the United States as having requirements equivalent to the APVMA’s good manufacturing practice (GMP) standards. On a case-by-case basis, the APVMA may recognise GMP evidence from a PIC/S participating authority/member.

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

Australia has a mutual recognition agreement (MRA) with the:

  • European Community (EC)
  • European Free Trade Association-European Economic Area (EFTA)
  • United Kingdom (UK).

These MRAs cover conformity assessments for human therapeutic goods, medical devices and veterinary chemical products.

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

The MRA allows 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.

1. European Community-Australian Mutual Recognition Agreement (EC-MRA)

The Agreement on Mutual Recognition in relation to Conformity Assessment, Certificates and Markings between Australia and the European Community (EC-MRA) entered into force on 1 January 1999. An amending agreement was entered into force on 1 January 2013.

The countries currently recognised by the EC-MRA are listed in the following table. The EC-MRA contains a list of regulators for human therapeutic products, the equivalent veterinary chemical regulatory authority is listed below.

The list of regulatory authorities is not exclusive, and other regulatory authorities may be considered for the recognised country.

Countries recognised by the EC MRA

Country

Regulatory authority

Country

Regulatory authority

Austria

Austrian Agency for Health and Food Safety

Italy

Ministry of Health

Belgium

Federal Agency for Medicines and Health Products

Latvia

Food and Veterinary Service

Bulgaria

Bulgarian Food Safety Authority

Lithuania

State Food and Veterinary Service

Cyprus

Veterinary Services, Ministry of Agriculture, Natural Resources and Environment

Luxembourg

Ministry of Health

Czech Republic

Institute for State Control of Veterinary Biologicals and Medicines

Malta

Veterinary and Phytosanitary Regulation Department

Denmark

Danish Health and Medicines Authority

Netherlands

Medicines Evaluation Board

Estonia

State Agency of Medicines

Poland

Chief Pharmaceutical Inspectorate

Finland

Finnish Medicines Agency

Portugal

National Authority for Animal Health

France

National Veterinary Medicines Agency

Romania

Institute for Control of Biological Products and Veterinary Medicines

Germany

Federal Office of Consumer Protection and Food Safety

Slovakia

Institute for State Control of Veterinary Biologicals and Medicaments

Greece

National Organization for Medicines

Slovenia

Agency for Medicinal Products and Medical Devices of the Republic of Slovenia

Hungary

Directorate of Veterinary Medicinal Products

Spain

Spanish Agency for Medicines and Health Products

Ireland

Health Products Regulatory Authority (HPRA)

Sweden

Medical Products Agency

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, EFTA or UK country can be made under the provisions of the MRA. 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 MRA, licence holders must then undergo an inspection by the Therapeutic Goods Administration (TGA) against the PIC/S Guide to 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, EFTA and UK recognises the APVMA as the authority to issue certificates and assist the manufacturer to coordinate the process.

2. European Free Trade Association-European Economic Area-Australian Mutual Recognition Agreement (EFTA MRA)

The countries currently recognised by the EFTA-MRA are listed in the following table. The EFTA-MRA contains a list of regulators for human therapeutic products, the equivalent veterinary chemical regulatory authority is listed below.

The EFTA-MRA covers Norway, Iceland and Liechtenstein under the Agreement on Mutual Recognition in Relation to Conformity Assessment, Certificates and Markings between Australia and the Republic of Iceland, the Principality of Liechtenstein and the Kingdom of Norway (EFTA MRA).

The list of regulatory authorities is not exclusive, and other regulatory authorities may be considered for the recognised country.

Countries recognised by the EFTA MRA

Country

Regulatory authority

Iceland

Icelandic Medicines Agency

Liechtenstein

Office of Health

Norway Norwegian Medicines Agency

3. United Kingdom-Australian Mutual Recognition Agreement (UK MRA)

The Agreement On Mutual Recognition in Relation to Conformity Assessment, Certificates And Markings Between the Government of Australia and the Government of the United Kingdom of Great Britain and Northern Ireland (UK) was signed in January 2019 and entered into force on 1 January 2021, when the EC-MRA no longer applied to the UK. It continues to apply the mutual recognition arrangements between Australia and the UK that are currently provided for under the EC-MRA.

The countries currently recognised by the UK-MRA are listed in the following table. The UK-MRA contains a list of regulators for human therapeutic products, the equivalent veterinary chemical regulatory authority is listed below.

The list of regulatory authorities is not exclusive, and other regulatory authorities may be considered for the recognised country.

Countries recognised by the UK MRA

Country

Regulatory authority

Northern Ireland & United Kingdom

Veterinary Medicines Directorate

4. 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.

5. 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 licence, and/or
  • audit report from a recognised authority.

Further information can be found on our website.

6. Recognition of Pharmaceutical Inspection Co-operation Scheme (PIC/S) members

The APVMA may recognise Pharmaceutical Inspection Co-operation Scheme (PIC/S) participating authorities as having GMP compliance equivalent to Australia’s for particular product types. Acceptable evidence is a:

  1. GMP certificate – within expiry and covering the nominated product and steps of manufacture, together with a
  2. GMP audit report – that relates to the inspection detailed on the GMP certificate.

Note: Where ‘Release for Supply’ has not been listed on the GMP certificate, the applicant must provide GMP evidence that this step has been fully assessed as compliant and/or request for an appropriately licensed manufacturer in Australia to perform this step of manufacture.

The PIC/S members may be for human therapeutic goods only, it is the applicant’s responsibility to ensure that any equivalent veterinary chemical regulatory authority is also an authorised participating authority.  

6.1. Countries recognised as PIC/S participating authorities

The list of PIC/S participating authorities can be found on the PIC/S website.

7. Other countries

No authorities are currently recognised in countries other than those listed above. For veterinary chemical product manufacturers in other countries, other types of 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 a:

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