OTC N2 applications and OTC medicine monographs

13 November 2017

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


Version history
Version Description of change Author Effective date
V1.0

Original publication:

  • aspirin tablets for oral use
  • paracetamol for oral use
  • ibuprofen for oral use
Therapeutic Goods Administration 6 September 2013
V2.0

Added:

  • pholcodine
  • topical imidazole antifungals
  • topical nasal decongestants
Therapeutic Goods Administration 10 June 2014
V3.0

Added:

  • guaifenesin
Therapeutic Goods Administration 15 December 2014
V4.0

Added:

  • loperamide hydrochloride
  • mebendazole
  • ranitidine hydrochloride
Therapeutic Goods Administration 16 December 2014
V5.0

Added:

  • bromhexine hydrochloride
  • dextromethorphan hydrobromide
  • Laxatives: docusate sodium and/or sennosides
  • hand sanitisers
Therapeutic Goods Administration 15 September 2015
V5.1 Updated web page text Therapeutic Goods Administration 10 May 2016
V5.2 Reformatted web page Therapeutic Goods Administration 18 May 2016
V5.3 Added version history table Therapeutic Goods Administration 13 November 2017