Dossier requirements for non-prescription medicines
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 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.
Listed and assessed listed medicines
- Guidance for completing the application form for an assessed listed medicine
- Mandatory requirements for an assessed listed medicine application to pass preliminary assessment
- CTD Module 1: Administrative information for assessed listed medicines
- Module 1.2.1: Assessed listed medicine general application information form
- CTD Module 1.5 - Assessed listed medicines - Restricted information certification form
- Assurances to accompany a L(A)1 application
- Australian regulatory guidelines for sunscreens (ARGS)
Registered non-prescription medicines
- Application for a new registered complementary medicine - grouped medicine
- OTC application placement flowchart
- OTC application placement question and answer tool
- Preparing an OTC application cover letter
- OTC new medicines registration process
- Registered complementary and OTC medicines application and submissions
- Mandatory requirements for an effective registered complementary medicine application
- OTC medicines advisory committee process