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.
- To list an assessed listed medicine (where information is required for evaluation)
- For medical device (including IVD) conformity assessment certification
- For evaluation of new ingredients for use in listed medicines
This guidance does not apply to the following applications:
- To list a complementary or OTC medicine (where 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.