Process for developing a standard for active constituents

In accordance with statutory responsibilities under the Agricultural and Veterinary Chemicals Code, the Australian Pesticides and Veterinary Medicines Authority (APVMA) routinely establishes standards for active constituents, which are normally the result of an assessment of a new chemical.?Currently, standards are only established for agricultural active constituents, although in the future standards may be established for veterinary active constituents.

New standard

When the APVMA becomes aware that a standard needs to be established, either through a formal application or through a review, the following procedure is implemented:

  1. A draft is prepared, taking into account batch analysis data from the manufacturer, and other relevant information, such as FAO specifications for active constituents. As far as possible, the APVMA standard will be harmonised with an FAO specification.
  2. Draft standards may be circulated for preliminary comment before consultation – generally a standard for a new active will be provided to the applicant.
  3. If the standard is for a new active constituent, there is a 28-day period for comment on the proposed standard and active constituent approval notified via an APVMA Gazette notice?as required for a new active constituent under section 12 of the Agvet Code. If the standard is for an existing active constituent, it will be included as part of the chemical review consultation process and timeframe.
  4. The standard is subjected to a final revision and published on the APVMA website with an updated version number and date of publication to differentiate it from any superseded version.?

Revision of an existing standard

From time to time existing standards may be revised as part of a chemical review, or in response to new information, or to correct errors. Minor changes such as corrections of typographical errors will simply be updated, while more substantial changes will be published on the APVMA website for consultation prior to adoption of the updated standard.

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