OTC new medicines registration process

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22 December 2015

This guidance is intended to assist applicants to register a non-prescription over-the-counter (OTC) medicine on the Australian Register of Therapeutic Goods (ARTG).

The following webpages:

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

Steps in the OTC registration process

  1. Verifying your OTC medicine and access to Business services
    Skip this step if you have already determined that you have:
    • an OTC medicine that requires registration
    • access to Business services.
  2. Checking for new medicine ingredients
  3. Determining your application level
  4. Checking guidelines and mandatory requirements
  5. Ensuring valid GMP evidence
  6. Compiling data for your application
  7. Completing and submitting your application
  8. Paying your fees
  9. Screening your application
  10. Evaluating and requesting information
  11. Making the OTC registration decision
  12. Finalising your OTC registration

Version history

Version Description of change Author Effective date
V1.0
  • Original publication
  • Replaces ARGOM Guidelines on pre - market application and evaluation process for OTC medicines v1.3 09/04/2014
OTC Medicines Regulatory Guidance November 2015
V1.1
  • Update to step 3 and step 8 of the process to reflect the new OTC fee structure commencing on 1 January 2016
COMB - OTC Medicines Evaluation Section December 2015

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