Allergen products: production and quality issues - Scientific guideline

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.

Keywords: Allergen products, homologous groups

Current effective version

Guideline on Allergen products: Production and quality issues

Adopted Reference Number: EMEA/CHMP/BWP/304831/2007 Legal effective date: 20/05/2009

Document history - First version (current)

Guideline on Allergen products: Production and quality issues

Adopted Reference Number: EMEA/CHMP/BWP/304831/2007 Legal effective date: 20/05/2009

Overview of comments received on the draft guideline on Allergen products: Production and quality issues

Reference Number: EMEA/CHMP/BWP/596200/2008

Draft guideline on Allergen products: Production and quality issues

Draft: consultation closed Reference Number: EMEA/CHMP/BWP/304831/2007