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Submit your application and dossier: prescription medicines

Find out how to submit your prescription medicine application and dossier.

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Certain information must be submitted to the TGA for prescription medicine applications to proceed to evaluation. 

Before you lodge your application, make sure you read Mandatory requirements for an effective application

Key information for applicants

Guidance and resources

More information

Dossier requirements

Common technical document

Electronic submissions

Orphan designations

Priority Determinations

Provisional determinations

Minor Variations (includes Cat 3, SAR, SRR, MEC, EOI Generics, 9D(2C) Notifications

Additional Trade Name Applications

Section 14 exemption requests

Product types