Inhalation and nasal spray registered medicines

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Application pathways and data requirements for registration of new generic medicines and variations to existing medicines

10 May 2018

1. Introduction

This guidance is for sponsors of inhalation and nasal spray registered medicines (prescription and OTC medicines) and provides guidance on application pathways and data requirements for:

  • new generic medicines
  • variations to existing medicines

This guidance applies to inhalation and nasal spray medicines that are any of the following:

  • metered-dose asthma inhalers
  • nasal corticosteroids
  • prescription medicines

This guidance does not cover the following dosage forms:

  • nasal drops
  • sublingual drops
  • medicinal gases.

1.1 About inhalation and nasal spray medicines

Nasal spray and inhalation products usually include a delivery device. The site of intended action of the active ingredient may be local or systemic.

  • Inhalation medicines are intended to be deposited in the respiratory tract
  • Nasal spray medicines are intended to be deposited in the nasal or pharyngeal region

Inhalation and nasal spray medicines typically have more variable bioavailability than medicines delivered by other routes of administration because of variability in use (e.g. in the patient's inspiratory flow pattern).

1.2 Systemically acting inhalation or nasal spray medicines

Arrange a pre-submission meeting with us if you wish to register a generic of a systemically acting inhalation or nasal spray medicine. Currently there are very few systemically acting inhalation and nasal spray medicines registered in Australia. The guidance below on establishing therapeutic equivalence does not apply to systemically acting medicines.

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