title: Authorised allergen products for intracutaneous testing may no longer be available in Germany: Allergy textbooks have to be re-written.
abstract: BACKGROUND
  Beside the skin prick test, the intracutaneous test represents the most important skin test method for detecting type-1 allergies. With the incorporation of European directives into national law, test allergens used for allergy diagnosis are deemed medicinal products within the meaning of the German Medicinal Products Act (Arzneimittelgesetz) and therefore require marketing authorisation for distribution in Germany. The high costs of acquiring and maintaining these authorisations have lead to no new finished intracutaneous test products being authorized in Germany for more than 20 years. Instead, most manufacturers have voluntarily withdrawn their existing marketing authorisations for intracutaneous test extracts. The last manufacturer to offer approved finished allergen products for intracutaneous tests recently announced that it would now cease production and distribution of these solutions.
  
  
  METHODS
  Research on the current European and German legislation; selective literature search in Medline, including national and international guidelines and Cochrane meta-analyses; licensing information on the Paul-Ehrlich-Institute homepage (www.pei.de) as well as in the Bundesanzeiger (Federal Gazette).
  
  
  RESULTS
  According to information on www.pei.de, marketing authorisations still existed as of 31.01.2015 for intracutaneous test solutions of six grass/cereal/herbal pollens, seven tree pollens, ten food allergens, twelve moulds and yeasts as well as two fungal mixtures, five house dust and storage mites and five animal epithelia/danders, all held by only one company in Germany. These marketing authorisations were granted between 16th March 1987 and 17th January 1992; more recent marketing authorisations do not exist.
  
  
  CONCLUSIONS
  European legislation and the associated increase in production and licensing costs have already lead to numerous suppliers withdrawing their marketing authorisation for diagnostic test allergens - marketing authorisations for 443 diagnostic allergens were voluntarily withdrawn by manufacturers in 2013 alone. If the announced restrictions on the allergen portfolio go ahead, considerable problems in the management of allergy patients in Germany due to the discontinuation of the intracutaneous test are likely to be encountered. Moreover, the fact that a diagnostic procedure that has been established for decades seems set to disappear quite simply because all the requisite substances vanish from the market in one fell swoop may well be without parallel in modern medicine. The situation for skin prick test allergens is less dramatic, although, here again, the available range is becoming increasingly limited.
authors.affiliation: Centre for Rhinology and Allergology, An den Quellen 10, 65183 Wiesbaden, Germany ; Medical Association of German Allergologists (Ärzteverband Deutscher Allergologen, AeDA), Dreieich, Germany.
authors.forename: Ludger
authors.initials: L
authors.lastname: Klimek
authors.affiliation: Dept of Dermatology, Allergology and Venereology, Division of Immunodermatology and Experimental Allergology, Hannover Medical University, Hannover, Germany ; German Society for Allergology and Clinical Immunology (Deutsche Gesellschaft für Allergologie und Klinische Immunologie, DGAKI), Aystetten, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Werfel
authors.affiliation: Department of Pediatrics and Adolescent Medicine, Dresden University Allergy Centre (UAC), Dresden, Germany ; German Society for Pediatric Allergology (Deutsche Gesellschaft für Pädiatrische Allergologie, GPA), Aachen, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Vogelberg
authors.affiliation: Group Practice for Dermatology, Immunology and Allergology, Erfurt, Germany ; Medical Association of German Allergologists (Ärzteverband Deutscher Allergologen, AeDA), Dreieich, Germany.
authors.forename: Kirsten
authors.initials: K
authors.lastname: Jung
keywords: allergen products; allergic rhinitis; diagnostic test allergens; intracutaneous testing; marketing authorisation