Gazette APVMA 7, 5 July 2005 page 21

NOTICE

Changes to Application Summaries

For certain applications, the APVMA is required to publish a summary of the application. The types of applications requiring an application summary include those for new active constituents, products and labels and applications involving variation to products and labels, where the variation involves a change in the use, supply or disposal of the product.

The APVMA has noted that the scope of applications caught by the early disclosure provisions is greater than was intended. The APVMA has been publishing summaries for various administrative applications as the purpose of these applications have met the criteria. Examples of these types of applications are:

· variation of registration and label approval to add a new container size;
· variation of registration to include a new container material;
· variation of registration to extend product shelf life from 12 months to 24 months;
· variation of label approval to update the storage and disposal instructions;
· variation of label approval to amend the label instruction as requested by the APVMA;
· variation of label to recommend use with compatible products.

The purpose of the early disclosure regime as outlined in the Government’s policy paper is to enable the community and stakeholders to be aware of important applications that relate to the use of chemical products and to demonstrate what data was required by the APVMA for these applications. By publishing summaries for the above mentioned applications, the summaries of interest are being diluted within those for administrative applications.
As a result, the APVMA, with the agreement of DAFF, will no longer be publishing summaries for the applications mentioned above after 1 July 2005.

For enquiries please contact:
Gavin Hall
Manager, Data Protection Unit
Legal and Governance Program
Ph - 02 6272 4405
Gavin.hall@apvma.gov.au