The EAMG position on the regulation of existing products for treatment with special reference to named patient products (NPPs).

Abstract

Allergen products have a long history in both diagnosis and management of allergic disease. It is emphasized that the availability of named patient products presents a valuable and indispensable option for the effective and safe treatment of patients suffering from IgE-mediated allergic diseases. A regulatory climate should be achieved in which these products can survive until a safe and effective alternative is borne out. Within the context of the paper the following definition is used: A named patient product or NPP is an allergen product, prepared with a specific reference number in accordance with a prescription for an individual patient, identified by the name of this patient and the reference number, and delivered after control of consistency with previous treatments. It is stressed that the standards of quality that hold for registered products are also applicable for named patient preparations which, for various reasons, can not be filed for registration. The paper frequently refers to a Position Paper that has recently been adopted by the European Allergen Manufacturers Group, the EAMG. The presentation breaks a lance for a concerted approach of the NPP-concept by striving at harmonization of legal, regulatory, manufacturing, and distribution conditions.