title: Impact of changed legislation on skin tests: the present and future.
abstract: To discuss the impact of current European Union regulations on the availability of commercially available skin test allergens in European member states.
  
  
  
  European Union legislations now define diagnostic allergens to be medicine requiring market authorization of every individual diagnostic allergen with obligations including clinical trials, application dossiers, a regular update of the dossiers, handling of variation processes and ongoing stability testing of the source material and periodic safety update reporting. The financial expenses of the initiation and maintenance of approvals for diagnostic allergens far exceed their related revenues. Thus, the numbers of authorized test allergens are steadily decreasing.
  
  
  
  The current European Union regulations are anticipated to have an immense impact on in-vivo allergy diagnosis in Europe. Available skin test allergens decreased to less than half of what has been before in recent years. EAACI has addressed both the EU and EMA to resolve this situation.
authors.affiliation: aCenter for Rhinology and Allergology, Wiesbaden, Germany bDepartment of Clinical Medicine, Aarhus University, Aarhus C, Denmark cDepartment of Women and Child Health, Padua General University Hospital, Padua, Italy dDepartment of Otorhinolaryngology, University Hospitals Leuven, Leuven, Belgium eDepartment of Otorhinolaryngology, Academic Medical Centre Amsterdam, The Netherlands fDepartment of Respiratory Disease and Allergy, Aarhus University Hospital, Denmark.
authors.forename: Ludger
authors.initials: L
authors.lastname: Klimek
authors.forename: Hans Jürgen
authors.initials: HJ
authors.lastname: Hoffmann
authors.forename: Alexa
authors.initials: A
authors.lastname: Kugler
authors.forename: Antonella
authors.initials: A
authors.lastname: Muraro
authors.forename: Peter W
authors.initials: PW
authors.lastname: Hellings
mesh_terms: D000485:Allergens / Q000276:immunology; D000818:Animals; D003362:Cost-Benefit Analysis; D005060:Europe; D005062:European Union; D033161:Government Regulation; D006801:Humans; D006967:Hypersensitivity / Q000175:diagnosis / Q000191:economics / Q000453:epidemiology*; D007878:Legislation as Topic; D012882:Skin Tests / Q000191:economics / Q000592:standards*
chemical_list: D000485:Allergens