Download ACVM REGISTRATION STANDARD AND GUIDELINE FOR EFFICACY OF ANTIHISTAMINE PRODUCTS

This document specifies the minimum study and reporting requirements, i.e. the standard,
for efficacy studies submitted in support of an application to register an antihistamine
product, or to vary the conditions on a registered antihistamine product. It also
incorporates guidelines, which are intended to provide more detailed information and
guidance to applicants to assist them in complying with the standard.