Abstract Background:Beside the skin prick test, the intracu-taneous test represents the most important skin test method for detecting type-1 allergies. With the in-corporation 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 (Arzneimittel-gesetz) and therefore require marketing authorisa-tion for distribution in Germany. ­e high costs of acquiring and maintaining these authorisations have lead to no new €nished intracutaneous test products being authorized in Germany for more than 20 years. Instead, most manufacturers have
voluntarily withdrawn their existing marketing au-thorisations for intracutaneous test extracts. ­e last manufacturer to o†er approved €nished aller-gen products for intracutaneous tests recently an-nounced 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 home-page (www.pei.de) as well as in the Bundesanzeiger (Federal Gazette).