Type
Guidance
Subjects
Processing, Veterinary Medicines, Agricultural Compounds & Veterinary Medicines (ACVM), Documents for veterinary medicines
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.
Published
Last updated