Jost R, Kespohl S, Paulus-Tremel KE, Zimmer J, Bonertz A, Sander I, Klose T, Altin LM, Heller S, Heimke-Brinck R, Dörje F, Philippus S, Meyer M, Segebrecht S, Wessel T, Starke D, Schülke S, Raulf M, Mahler V (2024)
Publication Type: Journal article, Review article
Publication year: 2024
Book Volume: 47
Pages Range: 411-424
Journal Issue: 6
DOI: 10.5414/ALX02514
The availability of high-quality skin test allergens is a prerequisite for the reliable diagnosis of occupational type I allergies. Due to the withdrawal of existing marketing authorizations (MA) by pharmaceutical companies and the lack of new MA for commercial test allergens, there is an increasing diagnostic gap in Germany and other EU member states, which makes it necessary to investigate alternative ways of the provision of in vivo diagnostics. The German Medicinal Products Act (AMG) allows for the possibility of preparing medicinal products in pharmacies without the need for a MA or a manufacturing authorization pursuant to Section 13 (2) No. 1 in conjunction with Section 13 (2a) Sentence 2 No. 3 AMG. This also includes test allergens. In addition to the AMG, the requirements of the German Ordinance on the Operation of Pharmacies (Apothekenbetriebsordnung – ApBetrO) and the European Pharmacopoeia apply in particular. Medicolegal and practical challenges, as well as potentials of the production of skin prick test solutions in public pharmacies are presented based on examples of different allergen source materials.
APA:
Jost, R., Kespohl, S., Paulus-Tremel, K.E., Zimmer, J., Bonertz, A., Sander, I.,... Mahler, V. (2024). Möglichkeiten der Fertigung von Testallergenen in öffentlichen Apotheken zur Diagnostik von Typ I-Allergien – rechtliche Aspekte. Allergologie, 47(6), 411-424. https://doi.org/10.5414/ALX02514
MLA:
Jost, R., et al. "Möglichkeiten der Fertigung von Testallergenen in öffentlichen Apotheken zur Diagnostik von Typ I-Allergien – rechtliche Aspekte." Allergologie 47.6 (2024): 411-424.
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