OTC N2 applications and OTC medicine monographs

10 May 2016

Overview

The N2 application route is available for proposed medicines that comply fully with a specific OTC medicine monograph and with associated general requirements.

N2 applications involve reduced requirements for data assessment by the TGA and consequently shorter evaluation timelines. In lieu of providing full supporting data with the application, sponsors need to complete a list of assurances confirming that the product meets the specified requirements.

Post-market monitoring of products approved via the N2 route will be conducted by the TGA to gain assurance regarding sponsor compliance with requirements.

Requirements

OTC medicine monographs

Further OTC medicine monographs will become available as they are developed.

A B D G H I L M P R T

A

B

D

G

  • Guaifenesin: OTC medicine monograph
    Requirements for Australian market authorisation of a cough expectorant containing guaifenesin as a single active ingredient when applied for as an OTC new medicine N2 application

H

  • Hand sanitisers: OTC medicine monograph
    Requirements for Australian market authorisation of hand sanitisers (hand rubs or hand washes) excluding those for presurgical use, when applied for as an OTC New Medicine N2 application

I

L

M

  • Mebendazole: OTC medicine monograph
    Requirements for Australian market authorisation of oral medicines containing mebendazole as a single active ingredient when applied for as an OTC New Medicine N2 application

P

  • Paracetamol for oral use: OTC medicine monograph
    Requirements for Australian market authorisation of oral medicines containing paracetamol as a single active ingredient when applied for as an OTC New Medicine N2 application
  • Pholcodine: OTC medicine monograph
    Requirements for Australian market authorisation of oral liquid preparations containing pholcodine as a single active ingredient when applied for as an OTC new medicine N2 application

R

T