Ensuring compliance after removing the Product Information insert

From 1 September 2023, injectable products administered by healthcare professionals are not required to come with a hard copy of the PI in the package of the product. This change only affects products administered by a healthcare professional, such as a nurse, pharmacist, or doctor.

Following this decision, we found that some products will still need to comply with paragraph 8(1)(l) of the Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91).

This paragraph explains the requirements for medicine labels when the medicine needs preparation before use, such as:

• dissolving
• suspending
• diluting, and
• reconstituting.

If there is not enough space on the label, you can put the instructions for preparation in a package insert providing that you have a statement on the label to say the instructions are in an insert.

In many cases the above information was included in the PI to allow for a single package insert. Other sponsors may include a reference to the PI on their labels which may no longer be required.

This guidance explains options for sponsors who wish to remove the Product Information from the packaging.

Options for the removal of PI

Figure 1 - Flowchart showing options for the removal of PI, as described below. 

Option 1: Updating the primary package when TGO 91 8(1)(l) is relevant.

• 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).

Option 2: Updating the primary package when TGO 91 8(1)(l) is not relevant.

• 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.

Option 3: When there is no action to be taken

• 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.

Example instructions for preparation package insert template

More Information

• Changes to the Product Information (PI) as a package insert for injectable products
• Labelling medicines to comply with TGO 91 and TGO 92
• Variations to prescription medicines: excluding variations requiring evaluation of clinical or bioequivalence data (for chemical entities)
• Variations to prescription medicines – excluding variations requiring evaluation of clinical or bioequivalence data: Appendix 2: Variation types – biological medicines