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Allergologie select, Volume 8 (2024) - 1st issue (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, Vera Mahler¹,²
¹ Allergology Division, Paul-Ehrlich-Institut (PEI), Langen (Hesse), ² Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, ³ Institute for Prevention and Occupational Medicine of the German Social Accident Insurance (DGUV), Institute of the Ruhr-Universität Bochum (IPA), Bochum, ⁴ Sonnenschein Apotheke, Koblenz, ⁵ Pharmacy Department, Erlangen University Hospital, Erlangen, ⁶ Thuringian State Authority for Consumer Protection, Department Pharmacy, Bad Langensalza, ⁷ Bundeswehr Commissioner for the Surveillance of Medicinal Products, Supervisory Agency for Public Law Tasks of the Bundeswehr Medical Service South, Munich, ⁸ Drug Supervision, State Social Services Agency of Land Schleswig-Holstein, Neumünster, ⁹ Pharmacy Inspector, Local inspectorate for pharmacies, District of Wesel, Moers, and ¹ ⁰ State Agency for Social Affairs, Youth and Care, Rhineland-Palatinate, Koblenz, Germany

DOI 10.5414/ALX02514E

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.

Author Details

Authors

Departments

¹ Allergology Division, Paul-Ehrlich-Institut (PEI), Langen (Hesse),
² Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen,
³ Institute for Prevention and Occupational Medicine of the German Social Accident Insurance (DGUV), Institute of the Ruhr-Universität Bochum (IPA), Bochum,
⁴ Sonnenschein Apotheke, Koblenz,
⁵ Pharmacy Department, Erlangen University Hospital, Erlangen,
⁶ Thuringian State Authority for Consumer Protection, Department Pharmacy, Bad Langensalza,
⁷ Bundeswehr Commissioner for the Surveillance of Medicinal Products, Supervisory Agency for Public Law Tasks of the Bundeswehr Medical Service South, Munich,
⁸ Drug Supervision, State Social Services Agency of Land Schleswig-Holstein, Neumünster,
⁹ Pharmacy Inspector, Local inspectorate for pharmacies, District of Wesel, Moers, and
¹
⁰ State Agency for Social Affairs, Youth and Care, Rhineland-Palatinate, Koblenz, Germany

Address

Prof. Dr. Vera Mahler, Paul-Ehrlich-Institut, Paul-Ehrlich-Straße 51-59, 63225 Langen, Germany
Email: [email protected]

Citation

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.Possible manufacture of test allergens in public pharmacies for the diagnosis of type I allergies: Legal aspects. Allergologie Select. 2024; 8: 251-264. doi: 10.5414/ALX02514E.

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