Common types of certificates

This guideline describes the types of certificates the Australian Pesticides and Veterinary Medicines Authority (APVMA) can issue under sections 69D and 70 of the Agricultural and Veterinary Chemicals (Administration) Act 1992.

1. Types of certificates of export issued under section 69D

We can issue a certificate under section 69D setting out our findings (if any) in relation to any matters relating to the chemical product that are required to be established for the purposes of export of the product.

The APVMA can provide several types of standard and specific certificates under this section. The standard certificates are based on commonly requested and accepted certificate formats, although you are not restricted to these types.

We must be able to verify all information placed on a certificate. It is your responsibility to supply all the information we ask for.

1.1. Certificate of Export

This certificate contains information about a registered agvet chemical product:

  • The product name
  • The registration number of the product
  • The registration holder’s name and address details
  • The name and manufacturing site address of the company that manufactures the product
  • The active constituents that appear on the label for the product, or the full formulation of the product
  • The number of certificates required
  • The name(s) of the destination country or countries
  • Whether Department of Foreign Affairs and Trade (DFAT) authentication is required
  • The applicable fee (including the additional fee if multiple DFAT authentications are required)

1.2. Certificate of Export (Unregistered Product)

This certificate contains information about an agvet chemical product that is not registered but would require registration if supplied in Australia. Before applying for a certificate of this type, an Item 19 permit must be obtained for the product, and evidence of a valid permit must be provided with the application.

  • The product name
  • The name and manufacturing site address of the company that manufactures the product
  • The active constituents that appear on the Item 19 Export Permit
  • The full formulation of the product (if applicable to the request)
  • Evidence of a valid export permit
  • The number of certificates required
  • Whether DFAT authentication is required
  • The name(s) of the destination country or countries
  • The applicable fee (including the additional fee if multiple DFAT authentications are required)

1.3. Certificate of Free Sale

This certificate contains information about a registered agvet chemical product that is supplied within Australia. We may require evidence of the product being supplied. This certificate is not issued for Schedule 4 and 8 veterinary products.

  • The product name
  • The registration number of the product
  • The registration holder’s name and address details
  • The name and manufacturing site address of the company that manufactures the product
  • The active constituents that appear on the label for the product or the full formulation of the product
  • The number of certificates required
  • Whether DFAT authentication is required
  • The name(s) of the destination country or countries
  • The applicable fee (including the additional fee if multiple DFAT authentications are required)

1.4. Certificate of Export and Manufacture (Approved GMP)

This certificate contains information about a registered veterinary chemical product and the manufacturing licence and Good Manufacturing Practice (GMP) compliance status of the site of manufacture of the product.

  • The product name
  • The registration number of the product
  • The registration holder’s name and address details
  • The name and manufacturing site address of the company that manufactures the product
  • The APVMA manufacturer’s licence number
  • The active constituents that appear on the label for the product or the full formulation of the product
  • The number of certificates required
  • Whether DFAT authentication is required
  • The name(s) of the destination country or countries
  • The applicable fee (including the additional fee if multiple DFAT authentications are required)

A Certificate of Export and Manufacture (Approved GMP) contains similar information to a 'Certificate of Pharmaceutical Product', but is not formally issued under the World Health Organization Certification Scheme on the Quality of Pharmaceutical Products moving in International Commerce.

The APVMA does not issue certificates titled a 'Certificate of Pharmaceutical Product'. These certificates are issued by the Therapeutic Goods Australia for human medications only.

1.5. Specialised certificates

The APVMA can also generate specialised certificates. We must be able to verify all the information for these certificates and it is important the receiving country’s specific requirements are confirmed and included on the certificates.

2. Types of certificates issued under section 70

We can issue a certificate under section 70 setting out certain things.

2.1. Certificate of Export (Active Constituent)

This certificate contains information about an approved active constituent.

  • The active name
  • The approval number of the active
  • The active holder’s name and address details
  • The name and manufacturing site address of the company that manufactures the active
  • The active constituent’s minimum impurity level
  • The number of certificates required
  • Whether DFAT authentication is required
  • The name(s) of the destination country or countries
  • The applicable fee (including the additional fee if multiple DFAT authentications are required)

2.2. Certificate of Manufacture

This certificate contains information about the manufacturing site of agricultural chemical products.

2.3. Certificate of Manufacture (Approved GMP)

This certificate contains information about the manufacturing licence and GMP compliance status of a veterinary chemical product manufacturing site.

2.4. Specialised certificates

We can also generate specialised certificates under section 70. We must be able to verify all information on the certificates. It is important to confirm the receiving country’s specific requirements and include these on the certificates.

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