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

The N2 application route is available for new over-the-counter (OTC) medicines that comply fully with a specific over-the-counter (OTC) medicine monograph and with associated general requirements.

Making an N2 application:

• reduces the amount of data that needs to be submitted to the TGA at the initial application stage, which reduces the evaluation time
• does not reduce the amount of data that the sponsor is required to hold.

Instead of providing full supporting data with the application, an applicant completes a list of assurances confirming that the product meets the specified requirements. You will find the list on Assurances to accompany an OTC new medicine N2 application.

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 OTC new medicine application process, see Understanding the OTC new medicines registration process.
• Understanding requirements for OTC new medicines N2 applications (using OTC medicine monographs)
  To be able to use the N2 application pathway, you need to ensure that your application meets the requirements for N2 applications.
• 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

A B G H I L M P T

A

• Aspirin tablets for oral use: OTC medicine monograph
  Understanding the requirements for an OTC new medicine N2 application for tablets containing aspirin as a single active ingredient.

B

• Bromhexine hydrochloride: OTC medicine monograph
  Understanding the requirements for an OTC new medicine N2 application for a preparation containing bromhexine hydrochloride as a single active ingredient.

G

• Guaifenesin: OTC medicine monograph
  Understanding the requirements for an OTC new medicine N2 application for a cough expectorant containing guaifenesin as a single active ingredient.

H

• Hand sanitisers: OTC medicine monograph
  Understanding the requirements for OTC new medicine N2 applications for hand sanitisers excluding those for presurgical use.

I

• Ibuprofen for oral use: OTC medicine monograph
  Understanding the requirements for an OTC new medicine N2 application for an oral medicine containing ibuprofen as a single active ingredient.

L

• Laxatives: Docusate sodium and/or sennosides: OTC medicine monograph
  Understanding the requirements for an OTC new medicine N2 application for an oral laxative medicine containing docusate sodium and/or sennosides.
• Loperamide hydrochloride: OTC medicine monograph
  Understanding the requirements for an OTC new medicine N2 application for an oral medicine containing loperamide hydrochloride as a single active ingredient.

M

• Mebendazole: OTC medicine monograph
   Understanding the requirements for an OTC new medicine N2 application for an oral medicine containing mebendazole as a single active ingredient.

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.

T

• Topical imidazole antifungals for dermal use - clotrimazole and miconazole nitrate: OTC medicine monograph
  Understanding the requirements for an OTC new medicine N2 application for a topical imidazole antifungal medicine for dermal use containing clotrimazole or miconazole nitrate as a single active ingredient.
• Topical nasal decongestants containing oxymetazoline hydrochloride or xylometazoline: OTC medicine monograph
  Understanding the requirements for an OTC new medicine N2 application for a topical nasal decongestant medicine containing oxymetazoline hydrochloride or xylometazoline hydrochloride as a single active ingredient.