Over-the-counter (OTC) N2 applications and medicine monographs

The N2 application route is available for proposed medicines that comply fully with a specific over-the-counter (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.

• For information on the N2 application process and how to submit N2 applications, see OTC new medicines registration process.
• Requirements for OTC new medicines N2 applications (using OTC medicine monographs)
  This document outlines the requirements for market authorisation of OTC medicines applied for via the New Medicine N2 application route
• Assurances to accompany an OTC new medicine N2 application
  This form is to be submitted as part of an OTC New Medicine N2 application

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

• Aspirin tablets for oral use: OTC medicine monograph
  Requirements for Australian market authorisation of tablets containing aspirin as a single active ingredient when applied for as an OTC New Medicine N2 application

B

• Bromhexine hydrochloride: OTC medicine monograph
  Requirements for Australian market authorisation of bromhexine hydrochloride as a single active ingredient when applied for as an OTC new medicine N2 application

D

• Dextromethorphan hydrobromide: OTC medicine monograph
  Requirements for Australian market authorisation of oral preparations containing dextromethorphan hydrobromide as a single active ingredient when applied for as an OTC new medicine N2 application

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

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

L

• Laxatives: Docusate sodium and/or sennosides: OTC medicine monograph
  Requirements for Australian market authorisation of oral laxative medicines containing docusate sodium and/or sennosides, when applied for as an OTC New Medicine N2 application
• Loperamide hydrochloride: OTC medicine monograph
  Requirements for Australian market authorisation of oral medicines containing ranitidine hydrochloride as a single active ingredient when applied for as an OTC New Medicine N2 application

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

R

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

T

• Topical imidazole antifungals for dermal use - clotrimazole and miconazole nitrate: OTC medicine monograph
  Requirements for Australian market authorisation of topical imidazole antifungal medicines for dermal use containing clotrimazole or miconazole nitrate as a single active ingredient when applied for as an OTC New Medicine N2 application
• Topical nasal decongestants: OTC medicine monograph
  Requirements for Australian market authorisation of topical nasal decongestant medicines containing oxymetazoline hydrochloride or xylometazoline hydrochloride as a single active ingredient when applied for as an OTC New Medicine N2 application