| Code | Description |
|---|---|
| 1. | The 'new' goods are intended to replace the existing goods in use. |
| 2. | The only difference between the 'new' goods and the existing goods is the name. |
| 3. | The only differences between the 'new' goods and the existing goods are related to the indications for use and/or the directions for use. |
| 4. | No additional indications have been introduced or directions for use altered (other than change to wording). |
| 5. | No aspects of the labelling, PI, CMI, pharmaceutical data or other product details (including manufacturing process), have been changed or are to be changed, other than changes nominated in this application and those made in conformity with the Changes Table. |
| 6. | The labelling for the new pack size is unchanged, other than to indicate the new pack size number/volume. |
| 7. | The only changes made are those which bring the label into compliance with requirements of the Labelling Order, or Schedule 2 to the Therapeutic Goods Regulations 1990. |
| 8. | The change is in compliance with a requirement introduced in the most recent version or amendment of the SUSMP. |
| 9. | The nominated manufacturer is licensed to manufacture goods of this type. |
| 10. | The container type (as defined in TGA Approved Terminology for Medicines) is unchanged and container material is unchanged. |
| 11. | A stability testing protocol has been approved for this product and a copy of the approval letter is attached. |
| 12. |
|
| 13. |
*Note: Validation data will be provided during a GMP inspection or upon request by the TGA within 3 months following the request (also see Guidelines on quality aspects of OTC applications) |
| 14. | No new text or graphics have been introduced. |
| 15. | This code is intentionally blank. |
| 16. | The new container/closure system has demonstrated equal or better moisture protection in the USP test for Containers - Permeation (water vapour transmission) to that of the existing container/closure system. |
| 17. | The information on the container label is not less than the information on the primary pack. |
| 18. | This code is intentionally blank. |
| 19. | Manufacturing method and specifications, other than visual identification, have not been changed. |
| 20. | Two production batches have been tested according to the approved stability protocol and all results fall within the acceptance criteria, as specified in the approved stability protocol. |
| 21. | The changes are in accordance with s.9D(1) of the Act. |
| 22 | This code is intentionally blank. |
| 23 | This code is intentionally blank. |
| 24 | Where a measuring device is being introduced or changed, it includes calibrations exclusively in metric units and will allow all the doses shown on the label to be measured accurately. |
| 25 | The container type (as defined in TGA Approved Terminology for Medicines) is unchanged. |
| 26 | This code is intentionally blank. |
| 27 | A copy of the current specification plus a copy of the new specification, with the changes highlighted, have been supplied. |
| 28 | This code is intentionally blank. |
| 29 | A copy of the current label of the goods together with a draft copy of the new package insert have been supplied. |
| 30 | A copy of the current label and package insert of the goods have been supplied. |
| 31 | A copy of the written advice from the TGA advising the use of this change code for the requested change to the product has been supplied. |
This webpage on the TGA website was printed on 12 Sep 2024. Printed content may be out of date. For up-to-date information, always refer to the digital version: https://www.tga.gov.au/resources/resource/guidance/changing-otc-medicine-using-changes-tables/assurance-codes