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.
More information
- 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