Ensuring compliance after removing the Product Information insert

If a medicine requires preparation before use as described in paragraph 8(1)(l) of TGO 91, then instructions for its preparation and, where relevant, a statement of the conditions of storage and the maximum period of storage between preparation and use are required on the label. If there is not enough space available on the label, then it can be set out on a package insert provided in the primary pack of the medicine.  For more information see: Labelling medicines to comply with TGO 91 and TGO 92.

If this information was previously found in the PI (as an insert) and the sponsor wishes to remove the PI, then they will need to either:

• include the information on the primary pack or container label; or
• include a new package insert with this information.

A template with recommendations for information to be included in the package insert is available below.

Updating the label or the package insert will require the use of the Self-assessable request (SAR) Code LOTG: Label - changes to comply with current TGOs for labels that have previously been evaluated and approved by the TGA. 

This code is available for use for both chemical and biological entities.

This code should only be used if there is no change to the information from what was approved in the PI. Please provide an assurance that there is no change to the information included in the approved PI.

The conditions remain the same:

• There must be no other changes to the label made under this change request.
• The changes must ensure continued compliance with the relevant TGO pertaining to labels and not contravene labelling best practice.
• You will be required to submit a copy of the new labels (including a package insert if used, as this is considered part of the label).

If a PI is removed from the package but was referenced on any outer packaging, then a notification should be submitted using the code LPIA: Label - addition of simple instructional/informational/anti-tampering statements or information about a changed appearance of the dosage form.

This code is available for use for both chemical and biological entities.

While this code is normally used for the addition of simple text, to provide a simple pathway for a label update as part of the change to the condition we can apply it for the removal of PI references.

The conditions are the same:

• There must be no other changes to the label made under this change request.
• The changes must ensure continued compliance with the relevant TGO pertaining to labels and not contravene labelling best practice.

If a sponsor has not referenced the PI on the label, then there is no regulatory action required.

If a sponsor wishes to continue to supply the approved PI as a package insert, then there is no action required.