Allergen products: production and quality issues

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Current effective version

Adopted guideline

Reference numberCHMP/BWP/304831/07
Published20/11/2008
Effective from20/05/2009
KeywordsAllergen products, homologous groups
DescriptionThis 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

Adopted guideline


Overview of comments


Draft guideline

In operation: 20/05/2009–present


Published: 24/07/2008


Published: 19/07/2006


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