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Due to changes to the scheduling of paracetamol medicines, which take effect from 1 February 2025, some solid-dose paracetamol products will be controlled as Schedule 3 (Restricted medicines). After 1 February 2025, affected medicines are legally required to have Product Information (PI) and Consumer Medicine Information (CMI) documents.
To facilitate and streamline the lodgement of change applications by sponsors of affected paracetamol over-the-counter (OTC) medicines to include new Product Information (PI) and Consumer Medicine Information (CMI) documents, template PI and CMI documents and temporary change codes have been developed and are available for use.
What is included in this change code
The TGA has developed template PI and CMI documents for sponsors to use to create these required documents for paracetamol single ingredient products affected by these scheduling changes. The temporary change codes DPP and KPN are C1 application level codes.
| Change code | Description | Status codes | Assurance codes* | Application level | Applicable section of the Act |
| DPP | Introduction of a PI for an existing product in compliance with SUSMP requirements for paracetamol identified in the final decision of 3 May 2023. The new PI must be identical to the core PI published on the TGA website other than the permitted changes identified in the core PI. | A | 5, 32 | C1 | 9D(3) |
| KPN | Introduction of a CMI as a package insert for an existing product in compliance with SUSMP requirements for paracetamol identified in the final decision of 3 May 2023. The new CMI must be identical to the core CMI published on the TGA website other than the permitted changes identified in the core CMI. | A | 5, 32 | C1 | 9D(3) |
| CPP | Introduction of a CMI for an existing product in compliance with SUSMP requirements for paracetamol identified in the final decision of 3 May 2023. The CMI is not to be included as a package insert. The new CMI must be identical to the core CMI published on the TGA website other than the permitted changes identified in the core CMI. Note: change code KPN applies where the CMI is to be included as a package insert. | O |
*Assurance codes
Assurance ‘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
Assurance ‘32’: The PI/CMI is identical to the core PI/CMI documents except for permitted changes as identified in the core PI and CMI documents
If you are making more than one change to your medicine it is important that you identify all applicable change codes to determine the correct application level. Each change that requires prior TGA approval corresponds to a particular application level based on risk (CN, C1, C2, C3 or C4). The application level is determined by the change that attracts the highest application level (CN being the lowest level and C4 the highest).
What is not included in this temporary change code
No changes to the template PI or CMI documents are permitted other than changes to product details where explicitly noted. Product details must match the current approved ARTG record.
Further details on the content and format of the PI are detailed in the Form for providing Product Information. Changes beyond those permitted in the template documents can be assessed using the guidance for changing an over-the-counter (OTC) medicine in the Australian Register of Therapeutic Goods.
Template documents
Product Information template for paracetamol
[DOCX, 44.97 KB]
Consumer Medicine Information template for paracetamol
[DOCX, 60.44 KB]