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.
• 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
• 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 (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.