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

Current effective version

PDF iconAdopted guideline

Currently under revision - see below

Reference number 7BIm11a
Published 01/09/1994
Effective from 01/09/1994
Keywords Allergen, veterinary
Description 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.

Document history

Revision 1

In progress

PDF iconDraft guideline



PDF icon Concept paper

Published: 19/12/2018

Deadline for comments: 31/08/2019


Published: 18/09/2015

First version

Current version

PDF iconAdopted guideline

In operation: 01/09/1994-present


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