Process to change a registered OTC medicine

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V1.2 June 2017

10 July 2017

This guidance is intended for sponsors applying to change the entry in the ARTG for a registered non-prescription over-the-counter (OTC) medicine.

The following webpages:

  • identify the regulatory process you need to follow
  • navigate you through the process, step by step
  • hyperlink to relevant guidance and forms.

Steps in the process

  1. Verifying your change requires prior approval from the TGA
  2. Determining your application level and change codes
  3. Checking relevant guidelines and requirements
  4. Obtaining an ID number for new proprietary ingredients
    • Skip this step if you are not including a new proprietary ingredient in the medicine
  5. Ensuring GMP evidence is valid
  6. Compiling data for your application
  7. Changing more than one medicine
    • Skip this step if you only want to change one medicine
  8. Completing and submitting your application
  9. Paying your fees
  10. Screening your application
  11. Evaluating and requesting information
  12. Making the decision
  13. Finalising your application

Version history

Version Description of change Author Effective date
V1.0 Original publication OTC Medicines Regulatory Guidance November 2015
V1.1 Update to steps 2, 8 and 9 of the process to reflect the new OTC fee structure commencing on 1 January 2016. COMB - OTC Medicines Evaluation Section December 2015
V1.2 Update to steps to reflect the new notification process commencing 1 July 2017. OTC Medicines Evaluation Section / Scientific Operations Management Section June 2017

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