You are here

Changing an OTC medicine: using the Changes Tables

Version 2.4, 4 December 2017

4 December 2017

Book pagination

Change table: Product Information (PI)

Changes to product information, including change codes, the change that can be made using this code, the status of the code, the assurance code, the application level for the change and the section of the therapeutic goods act that applies to the change
Change codes Product Information (PI) Status codes Assurance codes Application level Applicable section of the Act
DPI Introduction of a PI for an existing product where there is no requirement for supporting module 4 and/or module 5 data. For example, where the PI is essentially the same as the PI of the originator product. A 5 C2 9D(3)
DPD Introduction of a PI for an existing product where supporting module 4 and/or module 5 data or a justification for not providing the supporting data is required. For example, where the PI includes information on clinical trials and module 5 data are provided to substantiate the information included in the PI. A 5 C3 9D(3)
DAB

Minor editorial changes that have no regulatory compliance impact (under the Therapeutic Goods Act 1989). The changes are limited to the following:

  • correction of misspelt words and/or deletion of a duplicated word - this does not involve rewording or the deletion of sentences or phrases;
  • deletion of sponsor logo provided the name and address of the sponsor is included in the PI;
  • inclusion, removal or changes to:
    1. country of origin statement (e.g. 'Made in XX')
    2. sponsor address and/or contact details provided the information is consistent with the current approved product details and where the name and address of the sponsor of the goods is included in the PI
    3. supplier/manufacturer name, address and/or contact details
    4. ABN/ACN
    5. product code number (or equivalent) or an overseas registration number
    6. trade mark (™) or registration (®)symbols or similar or trademark statements e.g. Company XXY is a registered trademark of Company XXZ
O
DAC

Updating the PI to reflect the currently approved product details or changes consequential to other changes made in the same application. Changes are limited to the following:

  1. storage conditions
  2. sponsor details including sponsor name and/or logo (inclusion of a logo or change of an existing logo) except where DAB applies
  3. container or pack size details
  4. visual identification
  5. dosage form
  6. route of administration
  7. formulation details
  8. poisons schedule
  9. proprietary name
  10. indications (where the wording is identical to that included on the ARTG or that proposed for the ARTG as part of the same application)

Does not include changes to the directions for use

SAR 5 C1 9D(3)
DRS

Addition of more restrictive safety-related statements including:

  • reduction in the class of person for whom the goods are suitable e.g. changing a statement from 'not recommended for children under 12 years' to 'not recommended for children or adolescents under 18 years'
  • addition of a warning or precaution including a new RASML statement or an ARGOM warning statement

(See also LSR for consequential changes to labelling)

SRR 5 C1 9D(2)
DOT Changes (including addition or deletion of text or the rewording or reformatting of existing text) where there is no requirement for supporting module 4 and/or module 5 data, other than as specified in change DAB, DAC or DRS. A 5 C2 9D(3)
DOD Changes other than the addition of more restrictive safety-related statements where supporting module 4 and/or module 5 data or a justification for not providing the supporting data is required. For example, updating the section on Clinical Trials where the changes made are supported by module 5 data. A 5 C3 9D(3)
DRP Removal of a PI where the PI is not required under section 25AA of the Act. For example, removal of a PI for an unscheduled paracetamol 500mg tablet. A 5 C2 9D(3)

Book pagination