General dossier requirements
This guidance assists you as the applicant, to meet our requirements for the dossier of information you send to us for evaluation in support of the following types of applications:
- To register a medicine (prescription, OTC or complementary) on the ARTG
- To include a biological on the ARTG that requires evaluation of information
- To include a medical device (including IVD) on the ARTG if you have been advised that it will be audited and requested to provide information for the audit.
- For medical device (including IVD) conformity assessment certification
- To vary the ARTG record which requires supporting information
This guidance does not apply to the following applications:
- To list a complementary or OTC medicine (information is not required for evaluation)
- To include medical device on the ARTG (other than those selected for audit).
- To vary the ARTG record if supporting information is not required.
Note: An application for a variation to a prescription medicine will be submitted as an eCTD sequence.
- For Good Manufacturing Practice (GMP) certification or GMP clearance of overseas manufacturers.
Make sure to follow parts A to D of this guidance. Only follow Part E for hard copy paper dossiers if you are unable to send your information electronically.