Guidelines on OTC applications for specific substances

Purpose

This guidance document is intended to assist sponsors in submitting acceptable applications for registration of over-the-counter (OTC) medicines.

Products are assessed according to the best clinical and scientific information at the time of evaluation. If a sponsor believes that a particular application warrants a departure from the guidelines, a justification should be submitted with the application.

Sponsors of products that were approved before the introduction of a new guideline should bring the product into compliance with the guideline at the earliest opportunity, for example, when any changes are proposed to the product labelling.

Sponsors should also refer to the Required Advisory Statements for Medicine Labels (RASML).