Requirements for the quality (production and control), safety and efficacy of allergen products for use in horses, dogs and cats - Scientific guideline

This document provides guidance on the type of data which should be included in applications for marketing authorisation for allergens. The revised guideline will encompass production and quality issues concerning natural and biotechnology derived allergen products including derivatives with reduced IgE binding capacity and/or enhanced immunogenicity, fusion constructs containing polypeptides derived from allergens and non allergenic functional polypeptides.

Keywords: Allergen, veterinary