You are here
OTC new medicines registration process
Step 4 - Checking guidelines and mandatory requirements
When planning your OTC medicine application you will need to identify and understand the relevant mandatory requirements and guidelines.
Check all of the relevant guidelines for any specific requirements or advice that apply to your application:
- OTC-specific guidelines
- 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.
The mandatory requirements explain what you need to do for your application to be effective, pass screening and be accepted for evaluation:
- Mandatory requirements for an effective OTC medicine application
- CTD Module 1 - OTC medicines
- Note the requirement in CTD Module 1.5.8 to submit your own umbrella brand assessment for applications that require a higher level assessment due to the umbrella segment of the product name.
- Common Technical Documentation (CTD)
- General dossier requirements
- Cover letter
If you have read the applicable guidance and need our assistance, you can contact OTC Medicines by email. We will usually respond in writing as meetings are not needed for most OTC medicine applications.