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Section 19A: Guidance for industry

Supplying substitute medicines when registered medicines are unavailable or in short supply

4 January 2018

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Lapsing of approvals

An approval under section 19A can lapse before the end of the nominated approval period in the following circumstances:

  • any of the specific criteria for approval no longer apply, for example:
    • a decision has been made about whether or not to include the medicine in the ARTG
    • the medicine included in the ARTG is no longer unavailable or in short supply
  • a condition of approval has been breached – go to Consequences of not complying with conditions.

We will notify you in writing:

  • if the approval lapses before its expiry, and we will provide information on the reason for lapsing

    OR

  • within eight weeks before the expiration of the approval, as a matter of courtesy.

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.

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.

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