Registered medicine variation form (OTC medicines)

Use this form for applications for prior approval of, or to notify, changes to registered OTC Medicines. This form should only be used when you wish to vary the particulars of OTC medicines which are already registered in the ARTG.

This form should only be used after prior agreement with the OTC Medicines Section, if you are unable to use the online OTC Products Application Lodgement (OPAL) system.

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Registered medicine variation form (OTC medicines) (pdf,68kb)

Registered medicine variation form (OTC medicines) (zipped MS Word,92kb)