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Eudralex Volume 3 GUIDELINE ON ALLERGEN PRODUCTS: PRODUCTION AND QUALITY ISSUES

Short Title:
EMEA/CHMP/BWP/304831/2007
Origin/Publisher:

European Commission Enterprise and Industry DG, BREY 13/ 092, B - 1049 Brussels (Belgium), http://ec.europa.eu/enterprise/

Document Type:
CHMP Guideline
Content:
This document provides principles and guidance for the manufacturing and quality control of allergen products of biological origin, including allergen extracts from natural origin and allergens produced through recombinant DNA technology, used for specific immunotherapy (SIT) or in vivo diagnosis of immunoglobulin E (IgE) mediated allergic diseases.

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