European Medicines Agency Evaluation of Medicines for Human Use

This Guideline replaces the Note for Guidance on " Allergen products " (CPMP/BWP/243/96). This Guideline lays down the quality recommendations for allergen products of biological origin, including allergen extracts derived from natural source material and allergens produced through recombinant DNA technology, used for specific immunotherapy (SIT) or in vivo diagnosis of immunoglobulin E (IgE)-mediated allergic diseases.