This content is current only at the time of printing. This document was printed on 23 June 2021. A current copy is located at http://www.plural-consulting.com/node/321
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Common types of certificates
This guideline describes the types of certificates the 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 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.
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.
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.
1.4. Certificate of Export and Manufacture (Approved GMP)
This certificate contains information about a registered veterinary chemical product and the manufacturing licence and GMP compliance status of the site of manufacture of the product.
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'.
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 that 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.
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.