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.
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.
- PageManufacturing evidence for non-prescription medicinesManufacturing evidence for non-prescription medicines
- PageSafety and Quality of non-prescription medicinesAssuring the safety and quality of non-prescription medicines
- GuidanceListed medicines trainingLearning modules for sponsors of listed medicines as a supplement to Evidence Guidelines.