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Notification of proposal to submit supplementary data & submission of supplementary data
The 1997 TGA Review recommended that submission of new data during the evaluation process should be allowed and that where new data are submitted during the evaluation process, the clock should be stopped for an appropriate time to allow evaluation of the new data and that an appropriate fee should be charged by the TGA.
These forms should be used by sponsors to notify the TGA of a proposal to submit supplementary data and to submit supplementary data.
For information concerning the submission of supplementary data, refer to ARGPM Appendix 6 - Notification and submission of new data.