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ARGOM: Guidelines on changes to OTC medicines
V1.1, April 2013
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.