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General dossier requirements

27 July 2018

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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.

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.

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