Non-clinical local tolerance testing of medicinal products - Scientific guideline

This document provides guidance on the non-clinical local tolerance testing of medicinal products for human use. It addresses the development and evaluation of medicinal products that will, or have the potential to, come into contact with different sites of the human body following normal clinical use, as well as after unintentional administration.

Keywords: Non-clinical, local tolerance testing, toxicity studies, sensitising potential, oral, ocular, cutaneous, transdermal, parenteral, rectal, vaginal