You are here

TGA Internet site archive

The content on this page and other TGA archive pages is provided to assist research and may contain references to activities or policies that have no current application. See the full archive disclaimer.

ARGOM: Guidelines on changes to OTC medicines

V1.1, April 2013

29 November 2015

Book pagination

What data/information do I need to include with my application?

Once the sponsor has identified the correct application level for their application (refer Pre-market application and evaluation process), the sponsor can then refer to the OTC dossier documents matrix and appendices 1–5 of ARGOM to ascertain the data requirements for their application. Applications which include new or changed analytical procedures and associated validation data also need to include completed OTC analytical validation summary forms.

Book pagination