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Gazette APVMA 2, 1 February 2005 page 26
NOTICEReconsideration of Approvals and Registrations Related to the
Ag Active Scheme
The APVMA has completed its reconsideration for the majority of active constituent approvals and product registrations where an APVMA Standard has been published for the active constituent. Extensions were granted for a number of registrants until February 2005. The reconsideration for the remaining products will be completed after this time.
This activity is part of the APVMA’s initiative to ensure the ongoing quality of active constituents used in agricultural chemical products.
The basis for the reconsideration was outlined in the September 2004 Gazette. The purpose of the reconsideration was to impose new conditions of approval and registration to ensure that the requirements for continued registration and approval (public health and safety, the environment and trade) can be met. In particular that the quality of an active constituent in an agricultural chemical product in the market is consistent with that established at the time of registration.
The current conditions of approval and registration did not satisfy the APVMA requirements in this regard. Therefore the APVMA has varied the existing conditions of approval for 926 active constituents and varied the conditions of registration for 3181 products to incorporate the new conditions. This variation was effective 21 December 2004 with approval holders and registrants advised accordingly.
Under the new conditions persons supplying the active constituent will be responsible for ensuring that it complies with the APVMA Standard for that active constituent, as well as providing details of the batch number of the active constituent to the person to whom the active constituent is supplied.
Under the new conditions the registrant will be responsible for the supply of chemical product containing active constituent that complies with the APVMA Standard for that active constituent. The registrant will also be responsible for keeping records for the product including analysis of their active constituents or products to ensure that they comply with the relevant APVMA standards.
Further information concerning the new conditions of active constituent approval and product registrations are available on the APVMA website http://www.apvma.gov.au/actives/actives_implementation_sep_2004.shtml.
Pesticides Review Manager
Australian Pesticides and Veterinary Medicines Authority
PO Box E240
KINGSTON ACT 2604
For further information please contact (02) 6272 3213 or chemrev@apvma.gov.au.