Gazette APVMA5, 6 May 2003 - Page 50

NOTICE


Comments Sought on the Draft Guidelines for the
Validation of Analytical Methods

Section 11(1)(b) of the Agricultural and Veterinary Chemicals Code Act (Agvet Code) requires applications for active constituents, products and labels "to contain or to be accompanied by any information that the APVMA requires". Details of the specific requirements for approval of an active constituent and registration of agricultural and veterinary chemical products are contained in the APVMA's
Ag Requirements Series - Guidelines for Registering Agricultural Chemicals and
Vet Requirements Series - Guidelines for Registering Veterinary Chemicals.

The data requirements for analytical methods are included in Part 2 Chemistry and Manufacture of the Guidelines for Registering Agricultural/Veterinary Chemicals.

The APVMA has now prepared a draft guideline detailing the requirements for analytical method validation. The draft guidelines refer to both active constituent and products. They are not intended to apply to analytical methods for residue analysis, biological and biotechnological products. The APVMA seeks comment on this draft guideline from registrants of agricultural and veterinary chemical products, VMDA, AVCARE, and interested parties. Comments and suggestions regarding this document should be submitted to the APVMA by Friday 30 May 2003.

Copies of the Draft Guidelines for the Validation of Analytical Methods
are now available on the APVMA's website (). Copies can also be obtained by contacting Ms Juanita DeSilva on phone (02) 6272 3212, facsimile (02) 6272 3551 or via email juanita.desilva@apvma.gov.au

For further information please contact:

Dr Paul Sethi
Telephone: (02) 6272 3987



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