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Possible manufacture of test allergens in public pharmacies for the diagnosis of type I allergies: Legal aspects

Robin Jost, Sabine Kespohl, Kathrin E. Paulus-Tremel, Julia Zimmer, Andreas Bonertz, Ingrid Sander, Thomas Klose, Lena-Maria Altin, Simone Heller, Ralph Heimke-Brinck, Frank Dörje, Susanne Philippus, Matthias Meyer, Sabrina Segebrecht, Torsten Wessel, Dieter Starke, Stefan Schülke, Monika Raulf, and Vera Mahler

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Volume 8 (2024) p. 251 - 264

Abstract

Allergologie select, Vol. 8/2024 (251-264)

Possible manufacture of test allergens in public pharmacies for the diagnosis of type I allergies: Legal aspects

Robin Jost¹,², Sabine Kespohl³, Kathrin E. Paulus-Tremel¹, Julia Zimmer¹, Andreas Bonertz¹, Ingrid Sander³, Thomas Klose⁴, Lena-Maria Altin⁴, Simone Heller⁴, Ralph Heimke-Brinck⁵, Frank Dörje⁵, Susanne Philippus⁶, Matthias Meyer⁷, Sabrina Segebrecht⁸, Torsten Wessel⁹, Dieter Starke¹⁰, Stefan Schülke¹, Monika Raulf³, and Vera Mahler¹,²

¹Allergology Division, Paul-Ehrlich-Institut (PEI), Langen (Hesse), ²Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, ³Institute for Prevention and Occupational Medicine of the German Social Accident Insurance (DGUV), Institute of the Ruhr-Universität Bochum (IPA), Bochum, ⁴Sonnenschein Apotheke, Koblenz, ⁵Pharmacy Department, Erlangen University Hospital, Erlangen, ⁶Thuringian State Authority for Consumer Protection, Department Pharmacy, Bad Langensalza, ⁷Bundeswehr Commissioner for the Surveillance of Medicinal Products, Supervisory Agency for Public Law Tasks of the Bundeswehr Medical Service South, Munich, ⁸Drug Supervision, State Social Services Agency of Land Schleswig-Holstein, Neumünster, ⁹Pharmacy Inspector, Local inspectorate for pharmacies, District of Wesel, Moers, and ¹⁰ State Agency for Social Affairs, Youth and Care, Rhineland-Palatinate, Koblenz, Germany
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.Correspondence to:
Prof. Dr. Vera Mahler, Paul-Ehrlich-Institut, Paul-Ehrlich-Straße 51-59, 63225 Langen, Germany
Email: [email protected]

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