AI Article Synopsis

  • * The German Medicinal Products Act (AMG) allows pharmacies to prepare medicinal products, including test allergens, without needing a marketing authorization, which could help fill the diagnostic gap.
  • * The text discusses the practical and legal challenges of creating skin prick test solutions in pharmacies while exploring potential allergen sources and their implications.

Article Abstract

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 (MAs) by pharmaceutical companies and the lack of new MAs 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 providing in vivo diagnostics. The German Medicinal Products Act (Arzneimittelgesetz = AMG) allows for the possibility of preparing medicinal products in pharmacies without the need for an 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 manufacturing skin prick test solutions in public pharmacies are presented based on examples of different allergen source materials.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11270336PMC
http://dx.doi.org/10.5414/ALX02514EDOI Listing

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