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OTC medicines - Safety and efficacy data

30 November 2015

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1 - Specific OTC medicines

1.1 Higher risk medicines

The following higher risk OTC medicines are evaluated via the Prescription medicine pathway:

  • medicines containing oral nitrates for the treatment of heart disease
  • nasal corticosteroids and metered dose asthma inhalers
  • new transdermal patches (e.g. nicotine patches)

Refer to Guidance 19: Inhalation and nasal medicines for guidance on nasal corticosteroids and metered dose asthma inhalers.

Follow the prescription medicine registration process and submit data in accordance with the Australian Regulatory Guidelines for Prescription Medicines (ARGPM).

1.2 Nicotine replacement therapy

Refer to Nicotine replacement therapy (NRT) for specific guidance on safety and efficacy data for NRT medicines.

1.3 Other specific medicines

Refer to ARGOM Appendix 5: Guidelines on OTC applications for specific substances for guidance on safety and efficacy data requirements for various specific OTC medicines.

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