We will notify you in writing if the approval lapses before its expiry, and we will provide information on the reason for lapsing
If you want to continue supplying the medicine after the expiration or lapsing of an approval, you must make a new application under section 19A.
The lapsing of an approval or the expiry of the nominated approval period does not prevent another approval being granted under section 19A before the lapsing of the first period. Any subsequent approval may be expressed to take effect on the expiry of that period.
However, where the period has expired prior to a new approval being granted, you are prohibited from importing and supplying the medicine for the period between the two approvals.
19A(2) approvals lapse when a decision has been made about inclusion on the ARTG under section 23 of the Therapeutic Goods Act.
Where a new approval is requested to change from subsection 19A(2) to 19A(1) or 19A(1A) following a successful section 23 application to include the medicine in the ARTG, approval cannot take effect until the date of inclusion in the ARTG of the medicine. The TGA may assess a subsection 19A(1) or 19A(1A) application prior to the section 25(3) decision. However, the decision letter can only be provided on or after the section 25(3) decision date.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.