Acceptable evidence of overseas GMP compliance

Overseas veterinary chemical product manufacturers need to provide acceptable evidence of Good Manufacturing Practice (GMP) to the APVMA to import intermediate or finished product into Australia.

The type of evidence accepted by the APVMA depends on the type of product and which country it is manufactured in. Some overseas regulatory authorities are recognised by the APVMA. This means the APVMA considers their regulatory program to be similar and may accept their existing evidence of conformity assessment issued by their regulator.

1. Excluded nutritional and digestive products (END products)

Under the Animal Feed Reforms of 2015, a number of nutritional and digestive products no longer require APVMA registration. Where the exclusion criteria are satisfied, provision of evidence of GMP compliance to the APVMA is no longer be required for these excluded products. Where the products do not satisfy the exclusion criteria registrants will be required to provide acceptable evidence of Good Manufacturing Practice (GMP) to the APVMA.

2. Evidence from recognised EC and EFTA countries

2.1. Sterile and non-sterile medicinal products, vaccines and other immunobiologicals, ectoparasiticides, medicated stock feeds, premixes and supplements

A Certificate of GMP Compliance of a Manufacturer is an acceptable form of evidence.

If the manufacturing site is not listed on the EUDRA database, manufacturers should contact the relevant issuing authority to obtain a certificate.

Manufacturers experiencing difficulties obtaining the correct type of certificate from EUDRA or the relevant authority can contact the APVMA for assistance. If delays in auditing schedules cause delays in obtaining a certificate, contact the APVMA to discuss options.

2.2. Stock feed additives (direct-fed microbials, probiotics and enzymes) and therapeutic pet foods (excluding END products)

Manufacturing sites in EC and EFTA countries should be inspected and licensed by a government authority for compliance with manufacturing requirements in Regulation (EC) 183/2005.

The APVMA recommends manufacturers obtain a current certificate or other document—from the relevant overseas government authority—stating the facility has been inspected and complies with Regulation (EC) 183/2005. If this regulation has been transposed into national legislation, it must be clear that the evidence relates to Regulation (EC) 183/2005.

The APVMA also accepts evidence of GMP compliance from one of the European Community Feed Additives and PreMixtures Quality System (FAMI-QS) certification bodies in a recognised EC country for a manufacturing facility located in that same country. All of the following documents are required for the APVMA to accept evidence from FAMI-QS:

  • a certificate issued by a recognised certification body within the EC confirming that the site complies with the FAMI-QS requirements
  • a copy of the most recent audit report for the manufacturing facility
  • an original statutory declaration from the company confirming that quality control testing has been performed on the product and reviewed before its release.

Documents from other non-government authorities such as International Standards Organisation (ISO) inspection bodies are not acceptable.

3. Evidence from New Zealand

The evidence should be a current Certificate of GMP Compliance of a Manufacturer issued by the Agricultural Compounds and Veterinary Medicines Group (ACVM) of the Ministry for Primary Industries. The certificate should include:

  • details about the manufacturing site
  • the date of the most recent inspection and authorised product types
  • manufacturing steps.

Some veterinary products in New Zealand are exempt from registration through regulations under the ACVM Act as ‘specific requirements products’. The exempt products are a class of feed additives that require registration in New Zealand but not a GMP inspection of the premises manufacturing them. In those cases, an audit by an APVMA-authorised auditor or another recognised authority (such as an inspectorate from a recognised EC country) may be required.

4. Evidence from Switzerland

4.1. Sterile and non-sterile medicinal products, vaccines and other immunobiologicals, ectoparasiticides, medicated stock feeds, premixes and supplements

The evidence should be a certificate from Swissmedic, the Swiss agency for therapeutic products. The certificate should clearly state:

  • the manufacturer is authorised to manufacture veterinary medicinal products (or pharmaceutical products) in accordance with the laws and regulations of the Swiss Confederation
  • the manufacturing plant is regularly inspected and complies with GMP requirements as recommended by the World Health Organization or the Pharmaceutical Inspection Convention.

4.2. Stock feed additives (direct-fed microbials, probiotics and enzymes) and therapeutic pet foods (excluding END products)

Manufacturing sites in Switzerland should be inspected and licensed by a government authority for compliance with manufacturing requirements similar to the European Commission’s Regulation (EC) 183/2005.

For evidence, you will need a current certificate or other document that states:

  • the name and street address of the manufacturing site
  • the site is regularly inspected and the products are manufactured in accordance with the requirements of the Swiss equivalent of Regulation (EC) 183/2005.

If a document does not clearly state that it is produced under Swiss regulation—and is directly related to the European Commissions’ regulation—it must be accompanied by an explanatory letter. The letter needs to be issued by the relevant Swiss authority confirming the Swiss legislation relates to Regulation (EC) 183/2005.

5. Evidence from the United States

5.1. Immunobiologicals (vaccines, antisera and other biological products of a therapeutic nature)

The required evidence is a current Certificate of Licensing and Inspection from the US Department of Agriculture’s Animal and Plant Health Inspection Service, Veterinary Service. The certificate must state:

  • the name and address of the manufacturing site
  • that the product and the manufacturing site have been inspected and licensed under the laws and regulations of the United States.

Where the date of the establishment licence is more than three years old, a copy of the most recent inspection report or letter from the authority stating the last inspection date of the proposed facility must be provided.

If an expiry date is specified on these certificates, the certificate will only be acceptable for the time period nominated.

5.2. Sterile and non-sterile medicinal products (medicated stock feeds, premixes, supplements and performance enhancing biological products, such as boar taint vaccines and hormones)

The required evidence is a current Certificate to Foreign Government from the US Food and Drug Administration (FDA). It should state:

  • the name and street address of the manufacturing site and the products involved
  • that the product and the manufacturing plant are subject to the jurisdiction of the FDA
  • that the manufacturing plant is subject to periodic GMP-type inspections or audits
  • that the products and the manufacturing plant are in compliance with GMP.

The expiry date listed on these certificates is usually two years. The certificate should include either the product name, or the types of products which have been assessed.

Where the inspection date is not included within these certificates, the APVMA requires that the product applicant provide written confirmation regarding when the last inspection was conducted.

Where this certificate cannot be provided the APVMA also consider a copy of the most recent inspection report for the manufacturing facility issued by the US FDA which clearly indicates that the product has been included within the scope of the inspection and the site of manufacture is listed in the report.

The FDA does not regulate ectoparasiticides, stock feed additives or therapeutic pet foods.

5.3. Products listed above that are either not marketed in the United States or not yet registered

The US Department of Agriculture’s Centre for Veterinary Biologics and the US FDA does not usually issue appropriate certificates for export-only products or issue a certificate before a product is registered in the United States.

Certificates that refer to closely similar products manufactured at the same site may be considered on a case-by-case basis. An audit report from another recognised authority (such as an inspectorate from a recognised EC country) can also be considered as part of a documentary package, also on a case-by-case basis. Otherwise the APVMA may require an audit by an APVMA-authorised GMP auditor to confirm GMP compliance.

5.4. Ectoparasiticides, stock feed additives, such as direct-fed microbials, probiotics, enzymes and therapeutic pet foods (excluding END products)

As government agencies in the United States do not conduct GMP audits of these products to a standard equivalent to the Australian Code of GMP, no authorities are recognised.

An audit report from another recognised authority (such as an inspectorate from a recognised EC country) may be considered on a case-by-case basis. The APVMA may require an audit by an APVMA-authorised GMP auditor to confirm GMP compliance.

6. Evidence from Canada

6.1. Immunobiologicals (vaccines, antisera and other biological products of a therapeutic nature)

Evidence should be sought from the Veterinary Biologics Section of the Canadian Food Inspection Agency. The following documents must all be provided:

  • a current Veterinary Biologics Export Certificate, which confirms that the product is made in a licensed facility and the product is registered (licensed) in Canada
  • a current Veterinary Biologics Establishment Licence, which confirms that the site is licensed and gives details about authorised manufacturing steps
  • a copy of the most recent inspection report if the Veterinary Biologics Establishment Licence is more than three years old (to confirm that the site has had a recent inspection).

If the product is not marketed in Canada, the following documents should be sought:

  • a Veterinary Biologics Export Certificate that states the product is for export only and manufactured in a licensed establishment
  • a current Veterinary Biologics Establishment Licence, which confirms that the site is licensed and gives details about authorised manufacturing steps
  • a copy of the most recent inspection report if the Veterinary Biologics Establishment Licence is more than three years old (to confirm that the site has had a recent inspection).

If these documents cannot be provided, the APVMA is likely to require an audit by an APVMA-authorised auditor.

6.2. Sterile and non-sterile medicinal products including premixes and supplements

Evidence should be sought from Health Canada (Canada’s health department). The following document should be submitted:

  • Certificate of Compliance issued to Australia.

This certificate must include all pages. There must not be statements within the certificate’s pages indicating the product to be registered in Australia is not covered by the GMP inspection programme.

Where the above document is not available the following documents must be provided:

  • an Establishment Licence (issued to Canadian manufacturing facility) that shows the most recent inspection date
  • an Inspection Exit Notice (ie Inspection report) together with a letter of compliance rating for the most recent inspection at the site
  • a letter issued by Health Canada indicating a corrective action plan has been assessed and acceptable for the nominated manufacturing facility.

If these documents cannot be provided, the APVMA will require an audit for GMP compliance by an APVMA-authorised auditor.

6.3. Ectoparasiticides

No authorities are recognised in Canada for ectoparasiticides. An audit report from another recognised authority (such as an inspectorate from a recognised EC country) may be considered on a case-by-case basis. The APVMA usually requires an audit of GMP compliance by an APVMA-authorised GMP auditor.

6.4. Medicated stock feeds, stock feed additives and therapeutic pet foods, including direct-fed microbials, probiotics and enzymes (excluding END products)

No authorities are recognised, as government agencies in Canada do not conduct GMP audits for these products to a standard equivalent to the Australian Code of GMP.

An audit report from another recognised authority (such as an inspectorate from a recognised EC country) may be considered on a case-by-case basis. The APVMA may require an audit of GMP compliance by an APVMA-authorised auditor.

7. Evidence from all other countries

No authorities are currently recognised in countries other than those listed above.

An audit report from another recognised authority (such as an inspectorate from a recognised EC country) may be considered on a case-by-case basis. The APVMA may require an audit of GMP compliance by an APVMA-authorised GMP auditor.

8. Testing laboratories

Evidence of GMP compliance should be sought from recognised government authorities.

If evidence cannot be obtained from recognised authorities, the APVMA may consider certification for compliance with the ISO/IEC 17025 Standard. The National Association of Testing Authorities (NATA) has entered into MRAs with national accreditation bodies from a range of countries. Those bodies are listed in NATA’s MRA network.

Only certification for compliance with the ISO/IEC 17025 Standard from the listed accreditation bodies would be acceptable for consideration.

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