Upgraded over-the-counter medicines online application system

As announced on 7 March 2014, the upgraded system will become available on 9 April 2014.

Aspects that will commence with the upgraded system

1. Paper copy of application no longer necessary

As foreshadowed in the staged implementation plan published 12 months ago, it will no longer be necessary to submit a paper copy of the application. The electronic format copy alone will be acceptable from that date.

This is facilitated by the upgraded online application system. Applicants can submit their dossier and covering letter online, and this is the recommended approach. Help text appears in the user screen, and all guidance will continue to apply. See Over the counter medicines / Standards guidelines and publications. In particular refer to ARGOM: Guidelines on electronic OTC dossiers.

2. Target time for C2 application type will reduce

As foreshadowed in the staged implementation plan, the TGA has conducted a review of processing times. As a result with the introduction of the upgraded portal, the target time for evaluation of C2 type applications will fall from 105 working days to 90 working days. As more data becomes available on other types of applications that have been fully evaluated, target times for those will also be reviewed.

3. Introduction of a target time for initial evaluation of C2 type applications

With the introduction of the upgraded portal, a target time of 60 working days will be introduced for the initial evaluation of C2 type applications. Hence if no request for further information from the applicant is required, C2 type application will usually be completed within 60 days of acceptance for evaluation.

4. Interim arrangements for establishing page count fees

From the date of introduction of the upgraded portal until the OTC fee restructure has been implemented, interim arrangements will apply for those few applications that are liable for a page count fee. These are explained fully on page 15 ('Fees') in an update to the ARGOM: Guidelines for the pre-market application and evaluation process for OTC medicines which can be found on this website. See Over the counter medicines / Standards guidelines and publications.

5. Arrangements for assessing requests for certain types of fee reduction

From the date of introduction of the upgraded portal, revised arrangements for those few applications where, under Regulation 45 of the Therapeutic Goods Regulations, a fee reduction may be granted by the Secretary upon request from the applicant for concurrent applications with certain common characteristics. These are explained fully on page 15 ('Fees') in an update to the ARGOM: Guidelines for the pre-market application and evaluation process for OTC medicines which can be found on this website. See Over the counter medicines / Standards guidelines and publications.