[Governmental batch sample testing of allergen products]

Allergen products for specific immunotherapy of type I allergies were first authorized for the German market in the 1970s. In addition to finished products manufactured in advance and in batches, so-called named patient products have recently been defined as Medicinal Products by the German Medicinal Products Act ("Arzneimittelgesetz", AMG 14th Revision 2005). Some allergen products previously marketed as named patient products are now required to obtain marketing authorization according to the German ordinance for therapy allergens. Products have to be batch released by the competent German Federal Agency, the Paul-Ehrlich-Institut (PEI). Samples of product batches are delivered to the PEI in order to perform experimental quality controls. With regard to named patient products, PEI tests batch samples of the bulk extract preparations used for manufacturing of the respective, named patient products. The institute releases approximately 2,800 allergen product batches annually.