Allergen products: production and quality issues

Current effective version

PDF iconAdopted guideline

Reference number CHMP/BWP/304831/07
Published 20/11/2008
Effective from 20/05/2009
Keywords Allergen products, homologous groups
Description This document provides the quality recommendations for allergen products of biological origin. It applies to allergen extracts derived from natural source material and allergens produced through recombinant DNA technology, used for specific immunotherapy or in vivo diagnosis of IgE-mediated allergic diseases.

Document history

First version

Current version

PDF iconAdopted guideline


PDF iconOverview of comments


PDF iconDraft guideline

In operation: 20/05/2009–present


Published: 24/07/2008


Published: 19/07/2006

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