title: The regulatory system in europe with special emphasis on allergen products.
abstract: For each medicinal product quality, safety and efficacy have to be proven to obtain a marketing authorisation. The national competent health authorities and the European Medicines Agency (EMEA) with support of the Heads of Medicines Agencies (HMA) work together to grant marketing authorisations for medicinal products. Several regulatory procedures to apply for a marketing authorisation in the European Community (EC) and associated countries exist. After approval by a national procedure a medicinal product can be marketed in only one country. If a medicinal product should enter the markets of two or more European countries of choice the application has to undergo the Mutual Recognition Procedure (MRP) or the Decentralised Procedure (DCP). A marketing authorisation granted by the Centralised Procedure (CP) is valid in the whole EC. The CP is mandatory for certain medicinal products, for example all products derived from recombinant DNA technology including recombinant allergens. The guidance documents applicable to allergen products comprise general as well as product-specific guidelines such as the Note for Guidance on Allergen Products and the Monograph on Allergen Products of the European Pharmacopoeia. So-called 'named patient products' have a special status and are applied to patients without having a marketing authorisation. Recombinant allergens as medicinal products are insufficiently covered by the existing allergen product-specific guidelines, but product-specific guidelines are in the development stage.
authors.affiliation: Division of Allergology, Paul-Ehrlich-Institut, Langen, Germany.
authors.forename: A R
authors.initials: AR
authors.lastname: Lorenz
authors.forename: D
authors.initials: D
authors.lastname: Luttkopf
authors.forename: R
authors.initials: R
authors.lastname: Seitz
authors.forename: S
authors.initials: S
authors.lastname: Vieths
mesh_terms: D000485:Allergens; D000818:Animals; D002986:Clinical Trials as Topic; D004274:DNA, Recombinant; D004335:Drug and Narcotic Control; D005060:Europe; D017408:Guidelines as Topic; D006801:Humans; D007167:Immunotherapy; D007880:Legislation, Drug; D010602:Pharmacopoeias as Topic
chemical_list: D000485:Allergens; D004274:DNA, Recombinant