{"id":436,"date":"2026-01-15T15:39:28","date_gmt":"2026-01-15T14:39:28","guid":{"rendered":"https:\/\/www.lifescienceslaw.de\/allgemein\/produkthaftung-im-wandel-neue-anforderungen-fuer-apotheken\/"},"modified":"2026-04-24T07:49:48","modified_gmt":"2026-04-24T05:49:48","slug":"product-liability-in-transition-new-requirements-for-pharmacies","status":"publish","type":"post","link":"https:\/\/www.lifescienceslaw.de\/en\/rechtsbeitraege\/produkthaftung-im-wandel-neue-anforderungen-fuer-apotheken\/","title":{"rendered":"Product liability in transition: New requirements for pharmacies"},"content":{"rendered":"","protected":false},"excerpt":{"rendered":"","protected":false},"author":2,"featured_media":413,"menu_order":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[6],"tags":[161,160,155],"class_list":["post-436","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-rechtsbeitraege","tag-med-tech-und-health-care","tag-pharma-und-biotech","tag-ralph-schaefer"],"acf":{"header_address.Content":"","header_opening_hours.Content":"","header_phone_number.Content":"","child_entity.Value":"","001_page_meta.page_image10.Id":10,"001_page_meta.page_image9.Id":10,"001_page_meta.page_image8.Id":10,"001_page_meta.page_image7.Id":10,"001_page_meta.page_image6.Id":10,"001_page_meta.page_image5.Id":10,"001_page_meta.page_image4.Id":10,"001_page_meta.page_image3.Id":10,"001_page_meta.page_image2.Id":10,"001_page_meta.page_image1.Id":10,"0001_website_meta.site_logo.Id":1356,"galleries_enabled.Value":"true","multi_language_maps_enabled.Value":"false","001_page_meta.featured_image_mobile.Id":413,"001_page_meta.featured_image.Id":414,"001_page_meta.content_image_3.Id":null,"001_page_meta.content_image_2.Id":null,"001_page_meta.content_image_1.Id":null,"parent_entity.Value":"Ralph Schaefer","type_entity.Value":"rechtsbeitraege","0001_website_meta.site_logo_inverted.Id":368,"02_hero_content.hero_image3.Id":null,"02_hero_content.image_hero_content3.Id":null,"02_hero_content.image_hero_content2.Id":null,"02_hero_content.image_hero_content1.Id":null,"heading_hero_benefit3.Content":"","heading_hero_benefit2.Content":"","heading_hero_benefit1.Content":"","heading_hero_slider.Content":"","02_hero_content.hero_image8.Id":null,"02_hero_content.hero_image7.Id":null,"02_hero_content.hero_image6.Id":null,"02_hero_content.hero_image5.Id":null,"02_hero_content.hero_image4.Id":null,"top_heading_hero.Content":"<div>LIFE SCIENCES LAW - Ralph Sch\u00e4fer \u2013 Rechtsanwalt - Ihr Experte f\u00fcr rechtliche Fragen im Life Sciences-Sektor<\/div>","02_hero_content.hero_image2.Id":null,"02_hero_content.hero_image1.Id":null,"hero_content_form_benefit2.Content":"","hero_content_form_benefit1.Content":"","hero_content_form_benefit3.Content":"","hero_content_form.Value":"","hero_gallery_enabled.Value":"false","main_heading_hero_cta.Value":"\/kontakt","main_heading_hero_cta.Attribute":"Kontakt","sub_heading_hero.Content":"Fachbeitrag im Medizinprodukterecht","main_heading_hero.Content":"Produkthaftung im Wandel: Neue Anforderungen f\u00fcr Apotheken","subheading_contact_form.Content":"","contact_area_contact_form_phone_text.Content":"","contact_area_contact_form_name_text.Content":"","contact_area_contact_form_message_text.Content":"","contact_area_contact_form_mail_text.Content":"","contact_area_contact_form_button_text.Content":"","contact_form.Value":"","contact_address.Content":"","opening_hours.Content":"","map.Value":"","heading_contact_form.Content":"","telephone.Value":"","e-mail.Value":"","e-mail.Attribute":"","calendly_enabled.Value":"false","contact_image_enabled.Value":"","contact_maps_enabled.Value":"","calendly_url.Value":"","calendly_url.Attribute":"","online_form_name.Content":"","online_form_source.Value":"","testimonial3_customer.Content":"","04_social_proof.testimonial1_image.Id":null,"04_social_proof.testimonial2_image.Id":null,"04_social_proof.testimonial3_image.Id":null,"04_social_proof.google_places_review_image.Id":null,"04_social_proof.social_proof_background_image.Id":null,"heading_social_proof.Content":"","google_places_id2.Value":"","google_places_id.Value":"","testimonial1_customer.Content":"","testimonial1_text.Content":"","testimonial2_customer.Content":"","testimonial3_text.Content":"","testimonial2_text.Content":"","custom_reviews_enabled.Value":"","anwalt_de_widgetcode.Value":"","anwalt_de_enabled.Value":"","google_places_enabled.Value":"","google_places_reviews_enabled2.Value":"","google_places_reviews_enabled.Value":"","google_places_review_url2.Value":"","subheading_social_proof.Content":"","google_places_review_url.Value":"","social_proof_enabled.Value":"true","social_proof_disclaimer.Content":"","benefit_1_text.Content":"","05a_benefit_area.benefit_3_image.Id":null,"05a_benefit_area.benefit_2_image.Id":null,"05a_benefit_area.benefit_1_image.Id":null,"05a_benefit_area_enabled.Value":"true","benefit_heading_enabled.value":"false","benefit_heading.Content":"","benefit_3_text.Content":"","benefit_3_heading.Content":"","benefit_3_icon.Id":"","benefit_2_text.Content":"","benefit_2_heading.Content":"","benefit_2_icon.Id":"","benefit_1_icon.Id":"","benefit_1_heading.Content":"","benefit_1_widgetcode.Content":"","benefit_2_widgetcode.Content":"","benefit_3_widgetcode.Content":"","intro_heading.Content":"","intro_text.Content":"<div>Apotheken stehen vor erweiterten Haftungsrisiken. Die geplante Reform des Produkthaftungsrechts bringt neue Pflichten mit sich, insbesondere im Umgang mit Medizinprodukten, digitalen Gesundheitsanwendungen und softwarebasierten Systemen. Ein aktueller Gesetzentwurf sieht deutlich ausgeweitete Haftungsregeln sowie erh\u00f6hte Sorgfaltsanforderungen f\u00fcr Marktakteure vor.<\/div>","intro_gallery_enabled.Value":"false","05a_content_intro_enabled.Value":"true","overview_heading.Content":"","overview_text.Content":"","overview_cta_lead_in.Content":"","overview_cta.Attribute":"","overview_cta.Value":"","05b_content_overview_enabled.Value":"true","detail_heading_opt2.Content":"NO_SHOW","05c_content_detail.image_product5.Id":null,"detail_text_opt2.Content":"NO_SHOW","detail_call_to_action_enabled.Value":"false","detail_slider_enabled.Value":"false","detail_heading.Content":"Strukturwandel im Apothekenwesen","detail_text.Content":"<div>\n<p data-start=\"576\" data-end=\"1209\">Erstmals seit 1989 soll das deutsche Produkthaftungsrecht umfassend modernisiert werden. Hintergrund ist die Umsetzung der EU-Richtlinie 2024\/2853, die bis zum 9. Dezember 2026 in nationales Recht \u00fcberf\u00fchrt werden muss. Das Bundesministerium der Justiz und f\u00fcr Verbraucherschutz hat hierzu einen Referentenentwurf f\u00fcr ein neues Produkthaftungsgesetz vorgelegt. Ziel der Reform ist es, das Haftungsrecht an die fortschreitende Digitalisierung, neue Formen der Wertsch\u00f6pfung und globale Lieferketten anzupassen. Dabei wird insbesondere ber\u00fccksichtigt, dass viele Produkte heute von Herstellern au\u00dferhalb der Europ\u00e4ischen Union stammen.<\/p>\n<p data-start=\"1211\" data-end=\"1906\">Die ABDA hat zu dem Entwurf Stellung genommen und auf zentrale Neuerungen hingewiesen. K\u00fcnftig wird der Produktbegriff deutlich ausgeweitet. Neben klassischen Sachprodukten sollen auch Software, Systeme mit k\u00fcnstlicher Intelligenz sowie digitale Konstruktions- und Entwicklungsunterlagen unter das Produkthaftungsrecht fallen. Dar\u00fcber hinaus soll die Haftung nicht mehr ausschlie\u00dflich Hersteller treffen. Auch weitere Marktakteure wie Importeure, Lieferanten, Fulfilment-Dienstleister und bestimmte Plattformbetreiber k\u00f6nnen in Anspruch genommen werden, insbesondere dann, wenn der Hersteller seinen Sitz au\u00dferhalb der EU hat. Eine Haftungsh\u00f6chstgrenze ist im neuen Gesetz nicht mehr vorgesehen.<\/p>\n<p data-start=\"1908\" data-end=\"2247\">F\u00fcr Apotheken gewinnt das reformierte Produkthaftungsrecht vor allem im Bereich der Medizinprodukte, digitalen Gesundheitsanwendungen und eingesetzten Softwarel\u00f6sungen an Bedeutung. Arzneimittel selbst bleiben von der Reform ausgenommen, da hier weiterhin die spezielle Haftungsregelung des Arzneimittelgesetzes vorrangig Anwendung findet.<\/p>\n<\/div>","detail_cta_lead_in.Content":"","detail_cta.Attribute":"Kontakt","detail_cta.Value":"\/kontakt","detail_heading_opt1.Content":"Erh\u00f6hte Sorgfaltspflichten und IT-bezogene Risiken","detail_text_opt1.Content":"<div>\n<p data-start=\"2305\" data-end=\"2731\">Besonders relevant ist die geplante subsidi\u00e4re Lieferantenhaftung. Apotheken k\u00f6nnen k\u00fcnftig als Lieferanten haftbar gemacht werden, wenn sie Produkte au\u00dferhalb des Arzneimittelbereichs aus dem EU-Ausland beziehen und auf Nachfrage den tats\u00e4chlichen Hersteller oder Vorlieferanten nicht benennen k\u00f6nnen. Um dieses Risiko zu vermeiden, gewinnt eine l\u00fcckenlose Dokumentation der Liefer- und Herkunftskette erheblich an Bedeutung.<\/p>\n<p data-start=\"2733\" data-end=\"3177\">Neu ist au\u00dferdem, dass k\u00fcnftig auch die Zerst\u00f6rung oder Besch\u00e4digung von Daten als ersatzf\u00e4higer Schaden gilt. Dies betrifft insbesondere fehlerhafte Software oder digitale Systeme, etwa Warenwirtschaftsprogramme oder E-Rezept-Infrastrukturen. Zwar liegt die prim\u00e4re Haftung in diesen F\u00e4llen regelm\u00e4\u00dfig beim Systemhersteller, dennoch ergeben sich f\u00fcr Apotheken erh\u00f6hte Anforderungen an IT-Sicherheit, Dokumentation und interne Kontrollprozesse.<\/p>\n<p data-start=\"3179\" data-end=\"3490\" data-is-last-node=\"\" data-is-only-node=\"\">Die Reform macht deutlich, dass Apotheken ihre Rolle in der Liefer- und Nutzungskette technischer Produkte neu bewerten m\u00fcssen. Sorgf\u00e4ltige Organisation, transparente Lieferantenstrukturen und ein bewusster Umgang mit digitalen Systemen werden k\u00fcnftig entscheidend sein, um Haftungsrisiken wirksam zu begrenzen.<\/p>\n<\/div>","detail_cta_lead_in_opt1.Content":"NO_SHOW","detail_cta_opt1.Attribute":"NO_SHOW","detail_cta_opt1.Value":"NO_SHOW","05c_content_detail.image_person_slider3.Id":null,"05c_content_detail_enabled.Value":"true","detail_cta_lead_in_opt2.Content":"NO_SHOW","detail_cta_opt2.Attribute":"NO_SHOW","detail_cta_opt2.Value":"NO_SHOW","detail_heading_opt3.Content":"NO_SHOW","detail_text_opt3.Content":"NO_SHOW","detail_cta_lead_in_opt3.Content":"NO_SHOW","05c_content_detail.image_product1.Id":null,"detail_cta_opt3.Attribute":"NO_SHOW","05c_content_detail.image_product2.Id":null,"detail_cta_opt3.Value":"NO_SHOW","05c_content_detail.image_product3.Id":null,"detail_heading_opt4.Content":"NO_SHOW","05c_content_detail.image_product4.Id":null,"detail_cta_opt6.Attribute":"NO_SHOW","detail_cta_lead_in_opt4.Content":"NO_SHOW","detail_cta_opt4.Attribute":"NO_SHOW","05c_content_detail.image_product6.Id":null,"05c_content_detail.image_product7.Id":null,"detail_cta_opt4.Value":"NO_SHOW","05c_content_detail.image_product8.Id":null,"05c_content_detail.image_product9.Id":null,"detail_heading_opt5.Content":"NO_SHOW","detail_text_opt5.Content":"NO_SHOW","detail_cta_lead_in_opt5.Content":"NO_SHOW","detail_cta_opt5.Attribute":"NO_SHOW","detail_cta_opt5.Value":"NO_SHOW","detail_heading_opt6.Content":"NO_SHOW","detail_text_opt6.Content":"NO_SHOW","detail_cta_opt6.Value":"NO_SHOW","detail_text_opt4.Content":"NO_SHOW","05c_content_detail.image_staff_1.Id":null,"05c_content_detail.image_staff_2.Id":null,"05c_content_detail.image_staff_3.Id":null,"05c_content_detail.image_staff_4.Id":null,"05c_content_detail.image_staff_5.Id":null,"05c_content_detail.image_staff_6.Id":null,"05c_content_detail.image_person_slider1.Id":null,"05c_content_detail.image_office.Id":null,"detail_cta_lead_in_opt6.Content":"NO_SHOW","05c_content_detail.image_person_slider4.Id":null,"05c_content_detail.image_person.Id":null,"05c_content_detail.image_person_slider2.Id":null,"competence_heading.Content":"","competence_text.Content":"","competence_cta_lead_in.Content":"","competence_cta.Attribute":"","competence_cta.Value":"","05d_content_competence_enabled.Value":"true","05d_content_competence.competence_image1.Id":null,"05d_content_competence.competence_image2.Id":null,"services_heading.Content":"","services_text.Content":"","services_cta_lead_in.Content":"","services_cta.Attribute":"","services_cta.Value":"","05e_content_services_enabled.Value":"true","faq_heading.Content":"FAQs \u2013 H\u00e4ufig gestellte Fragen zur Produkthaftungsreform","question2.Content":"<div>Ab wann gelten die neuen Regelungen zum Produkthaftungsrecht?<\/div>","question3.Content":"<div>Welche Bedeutung hat die Reform konkret f\u00fcr Apotheken?<\/div>","question4.Content":"<div>Sind Arzneimittel von der neuen Produkthaftung betroffen?<\/div>","question5.Content":"<div>K\u00f6nnen Apotheken k\u00fcnftig selbst haftbar gemacht werden?<\/div>","question6.Content":"<div>Was bedeutet die subsidi\u00e4re Lieferantenhaftung f\u00fcr Apotheken?<\/div>","question7.Content":"<div>Welche Rolle spielt Software im neuen Produkthaftungsrecht?<\/div>","question8.Content":"<div>Sind auch Datenverluste k\u00fcnftig ersatzf\u00e4hige Sch\u00e4den?<\/div>","question9.Content":"<div>Welche organisatorischen Ma\u00dfnahmen sollten Apotheken jetzt pr\u00fcfen?<\/div>","question10.Content":"<div>Wann ist rechtliche Beratung im Zusammenhang mit der Produkthaftungsreform sinnvoll?<\/div>","question1.Content":"<div>Was \u00e4ndert sich durch die Reform des Produkthaftungsrechts?<\/div>","answer10.Content":"<div>Eine spezialisierte Beratung ist insbesondere bei der Bewertung neuer Haftungsrisiken, der Gestaltung von Lieferanten- und Softwarevertr\u00e4gen, der Dokumentation von Lieferketten sowie bei beh\u00f6rdlichen oder haftungsrechtlichen Fragestellungen sinnvoll. Life Sciences Law unterst\u00fctzt Apotheken dabei, die neuen Anforderungen rechtssicher und praxisnah umzusetzen.<\/div>","answer3.Content":"<div>F\u00fcr Apotheken ist die Reform insbesondere relevant im Umgang mit Medizinprodukten, digitalen Gesundheitsanwendungen, Warenwirtschaftssystemen und sonstiger Software. In diesen Bereichen k\u00f6nnen neue Haftungs- und Sorgfaltspflichten entstehen.<\/div>","answer4.Content":"<div>Nein. Arzneimittel unterliegen weiterhin der speziellen Haftungsregelung des Arzneimittelgesetzes. Das neue Produkthaftungsgesetz greift hier nicht, da das AMG als spezielles Haftungsregime vorrangig bleibt.<\/div>","answer5.Content":"<div>Ja, unter bestimmten Voraussetzungen. Apotheken k\u00f6nnen als Lieferanten in Anspruch genommen werden, insbesondere wenn sie Produkte aus dem EU-Ausland beziehen und den Hersteller oder Vorlieferanten auf Anfrage nicht benennen k\u00f6nnen.<\/div>","answer6.Content":"<div>Die subsidi\u00e4re Lieferantenhaftung greift, wenn der eigentliche Hersteller au\u00dferhalb der EU sitzt oder nicht identifizierbar ist. In solchen F\u00e4llen kann die Haftung auf den Lieferanten \u00fcbergehen. F\u00fcr Apotheken macht dies eine sorgf\u00e4ltige Dokumentation der Lieferkette unverzichtbar.<\/div>","answer7.Content":"<div>Software, einschlie\u00dflich Warenwirtschaftssystemen, E-Rezept-L\u00f6sungen und digitalen Anwendungen, gilt k\u00fcnftig ausdr\u00fccklich als Produkt. Fehlerhafte Software kann daher haftungsrelevante Sch\u00e4den ausl\u00f6sen, etwa durch Datenverlust oder Systemausf\u00e4lle.<\/div>","answer8.Content":"<div>\n<p data-start=\"2458\" data-end=\"2758\">Ja. Nach dem neuen Produkthaftungsrecht sollen auch die Zerst\u00f6rung oder Besch\u00e4digung von Daten als ersatzf\u00e4higer Schaden gelten. Dies erh\u00f6ht die Bedeutung von IT-Sicherheit, Datensicherung und dokumentierten Schutzma\u00dfnahmen in Apotheken.<\/p>\n<\/div>","answer9.Content":"<div>Apotheken sollten ihre Lieferanten- und Herstellerdokumentation \u00fcberpr\u00fcfen, IT-Systeme und Softwarevertr\u00e4ge kritisch betrachten und interne Prozesse zur Dokumentation und Nachvollziehbarkeit st\u00e4rken, um Haftungsrisiken zu reduzieren.<\/div>","answer1.Content":"<div>Das Produkthaftungsrecht wird erstmals seit 1989 umfassend reformiert. K\u00fcnftig sollen digitale Produkte wie Software, KI-Systeme und digitale Konstruktionsunterlagen ausdr\u00fccklich als Produkte gelten. Zudem wird der Kreis der haftenden Marktakteure erweitert und eine Haftungsh\u00f6chstgrenze abgeschafft.<\/div>","answer2.Content":"<div>Die zugrunde liegende EU-Richtlinie 2024\/2853 muss bis zum 9. Dezember 2026 in deutsches Recht umgesetzt werden. Mit dem Inkrafttreten des neuen Produkthaftungsgesetzes ist daher sp\u00e4testens ab diesem Zeitpunkt zu rechnen.<\/div>","05f_questions_and_answers_enabled.Value":"true","seoarea1heading.Content":"","seoarea1text.Content":"","seoarea2heading.Content":"","seoarea2text.Content":"","seoarea3heading.Content":"","seoarea3text.Content":"","seoarea4heading.Content":"","seoarea4text.Content":"","05g_seoarea_enabled.Value":"true","06_gallery_related1.gallery_related.TypeEntityName":"rechtsgebiete","06_gallery_related1.gallery_related.SubHeading":"","06_gallery_related1.gallery_related.Heading":"Branche","06_gallery_related1.background_image.Id":381,"06_gallery_related1.gallery_related.ButtonCtaText":"Kontakt","06_gallery_related1.gallery_related.ButtonCtaUrl":"\/kanzlei\/kontakt","gallery_related1_filterable_tabs_enabled.Value":"false","06_gallery_related1_enabled.Value":"true","06_gallery_related2.gallery_related.TypeEntityName":"","06_gallery_related2.gallery_related.SubHeading":"","06_gallery_related2.gallery_related.Heading":"","06_gallery_related2.background_image.Id":381,"06_gallery_related2.gallery_related.ButtonCtaText":"","06_gallery_related2.gallery_related.ButtonCtaUrl":"","06_gallery_related2_enabled.Value":"false","06_gallery_related3.gallery_related.TypeEntityName":"","06_gallery_related3.gallery_related.SubHeading":"","06_gallery_related3.background_image.Id":381,"06_gallery_related3.gallery_related.ButtonCtaText":"","06_gallery_related3.gallery_related.ButtonCtaUrl":"","06_gallery_related3.gallery_related.Heading":"","06_gallery_related3_enabled.Value":"false","06_gallery_related4.gallery_related.EnityId":"","06_gallery_related4.gallery_related.SubHeading":"","06_gallery_related4.gallery_related.Heading":"","06_gallery_related4.background_image.Id":null,"06_gallery_related4.gallery_related.ButtonCtaText":"","06_gallery_related4.gallery_related.ButtonCtaUrl":"","06_gallery_related4_enabled.Value":"","06_gallery_related5.gallery_related.EnityId":"","06_gallery_related5.gallery_related.SubHeading":"","06_gallery_related5.gallery_related.Heading":"","06_gallery_related5.background_image.Id":null,"06_gallery_related5.gallery_related.ButtonCtaText":"","06_gallery_related5.gallery_related.ButtonCtaUrl":"","06_gallery_related5_enabled.Value":"","instagram_feed.Content":"","toc_heading.Content":"Inhalt","heading_call_to_action.Content":"<div>Jetzt Anfrage stellen<\/div>","subheading_call_to_action.Content":"<div>Wir beraten Sie gerne umfassend und pers\u00f6nlich bei Ihrem Anliegen.<\/div>","cta_call_to_action.Attribute":"Kontakt","cta_call_to_action.Value":"\/kontakt","call_to_action_video_enabled.Value":"","video_call_to_action_youtube_url.Value":"","video_call_to_action_youtube_url2.Value":"","06a_home_call_to_action.image_call_to_action.Id":385,"06a_home_call_to_action_enabled.Value":"true","benefit1_call_to_action.Content":"true","benefit2_call_to_action.Content":"true","benefit3_call_to_action.Content":"true","benefit4_call_to_action.Content":"true","footer_contact_address.Content":"<div>M\u00fcnchner Strasse 33 <br>82319 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