Your application to change an ARTG entry for a registered OTC medicine needs to clearly describe each proposed change and include information to support the change so that it will pass screening and be accepted for evaluation. Notification applications do not undergo a screening process.
To determine the information necessary to support the change, you need to identify and understand the relevant requirements and guidelines:
- CTD Module 1: OTC medicines
- relevant for all applications to change an OTC medicine.
- Mandatory requirements for an effective OTC medicine application
- relevant for change applications:
- made under s23 of the Act. For example, changing the indications or directions for use (change codes GID and GDD)
- when supplying CTD Modules 3, 4 or 5.
- relevant for change applications:
- OTC-specific guidelines, in particular:
- for quality related changes see Guidelines on quality aspects of OTC applications
- for safety and efficacy related changes see Guidelines on efficacy and safety aspects of OTC applications
- for changes to the presentation see Guidelines on presentation aspects of OTC applications.
- European Union and ICH guidelines adopted in Australia: guidelines prepared by the European Committee for Medicinal Products for Human Use (CHMP) and/or those prepared within the ICH process that have been adopted by the TGA.
Need assistance
If you have read the applicable guidance and need our assistance email OTC medicines with your enquiry.
We will usually provide written advice. Meetings are not needed for most OTC medicine applications.
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