Dossier requirements for non-prescription medicines

Registered complementary and over-the-counter medicines

The Common Technical Document (CTD)  sets out the format for an application when applying to register a medicine in the Australian Register of Therapeutic Goods (ARTG).

The CTD specifies the organisation of the information across 5 modules so they are grouped logically and can be easily located:

• Module 1: Administrative information and prescribing information for Australia
• Module 2: Summaries of quality, safety and clinical data
• Module 3: Quality
• Module 4: Non-clinical data (safety)
• Module 5: Clinical data (efficacy)

The actual content of the dossier for a registered non-prescription medicine application will vary according to the application category.

Assessed listed medicines

The application dossier for assessed listed medicines is based on a simplified version of the CTD structure. This structure allows evaluators to quickly and efficiently locate specific information.

You are encouraged to request a pre-submission meeting with the TGA to ensure you are aware of the legislative requirements for the assessed listed pathway and the data required for an application to be accepted for assessment. If it is determined at the meeting that the proposed data dossier is likely to be critically deficient, sponsors have the opportunity to address these deficiencies prior to submitting their application.

Listed medicines

Listed medicines are considered to pose a low risk to consumers than registered medicines based on their ingredients and/or the therapeutic indications.

Listed medicines can be sold without undergoing a full pre-market assessment of safety, quality and efficacy by the TGA because they satisfy certain criteria. Sponsors certify at the time of listing their medicine on the ARTG that they have met legislative requirements and hold evidence to support their medicine.

An evidence package should contain a critical appraisal of your evidence and demonstrate how it supports the listed medicine’s efficacy.