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ARGOM Appendix 1: Guidelines on efficacy and safety aspects of OTC applications

Version 1.0

29 November 2015

Book pagination

7. Product specific requirements

7.1 Nasal corticosteroid sprays/aerosols

Given the specialised clinical and quality data requirements for registration of these products, applications for registration of these products have routinely been referred to the prescription medicines evaluation area for evaluation. Such applications should be submitted to the Office of Medicines Authorisation of prescription and other medicines in accordance with the Australian Regulatory Guidelines for Prescription Medicines (ARGPM). The safety and efficacy data required to support the registration of OTC corticosteroid nasal sprays/aerosols are as indicated in the ARGPM Appendix 19 Metered dose aerosols (pressurised and non-pressurised).

7.2 Nicotine replacement therapy products

The safety and efficacy data requirements for nicotine replacement therapy (NRT) products are included in ARGOM Appendix 5 Guidelines on OTC applications: Nicotine replacement therapy. Applications for new transdermal NRT products should be submitted to the Office of Medicines Authorisation of prescription and other medicines in accordance with the Australian Regulatory Guidelines for Prescription Medicines (ARGPM), in accordance with Part 1 of Schedule 10 of the Therapeutic Goods Regulations 1990 (the Regulations).

7.3 Antiseptics/skin disinfectants

The safety and efficacy data requirements for antiseptics and skin disinfectants are specified in the ARGOM Appendix 6 Antiseptics/skin disinfectants [still to be finalised].

7.4 Metered-dose inhalers

Given the specialised clinical and quality data requirements for registration of these products, applications for registration of these products have routinely been referred to the prescription medicines evaluation area for evaluation. Such applications should be submitted to the Office of Medicines Authorisation of prescription and other medicines in accordance with the Australian Regulatory Guidelines for Prescription Medicines (ARGPM). The safety and efficacy data required to support the registration of OTC metered dose inhalers for use in asthma are as indicated in the ARGPM Appendix 19 Metered dose aerosols (pressurised and non-pressurised).

7.5 Oral nitrate products

Given the specialised clinical and quality data requirements for registration of these products and the serious nature of the conditions being treated, applications for registration of these products have routinely been referred to the prescription medicines evaluation area for evaluation. Such applications should be submitted to the Office of Medicines Authorisation of prescription and other medicines in accordance with the Australian Regulatory Guidelines for Prescription Medicines (ARGPM).

Book pagination