{"id":12239,"date":"2016-04-07T16:19:40","date_gmt":"2016-04-07T14:19:40","guid":{"rendered":"https:\/\/www.vita34.de\/en\/genehmigungen\/"},"modified":"2016-08-30T12:47:08","modified_gmt":"2016-08-30T10:47:08","slug":"permits","status":"publish","type":"page","link":"https:\/\/www.vita34.ch\/en\/permits\/","title":{"rendered":"Permits"},"content":{"rendered":"<p>Vita 34 owns comprehensive permits, licenses, concessions, and accreditations.<\/p><p>The compliance with the strictest quality standards is reflected in the various permits and licenses. In addition to the license concerning the autologous release of umbilical cord blood, Vita 34 is the only private stem cell bank in Germany that owns the following licenses:<\/p><ul><li>Licenses issued by the German Federal Institute for Vaccines and Biomedicines (Paul Ehrlich Institute) concerning the release of umbilical cord blood preparations for therapeutic application in case of hematologic-oncological diseases for siblings and in order to help other people by means of donation<\/li><li>License to collect, process, cryo-preserve, and store umbilical cord tissue in Germany, Austria, and Switzerland (DACH region)<\/li><li>Licenses to offer customers the storage of whole blood and separated blood.<\/li><\/ul><p>This comprehensive range of licenses and permits helps Vita 34 to create the requirements to enhance the range of services and products constantly for our customers.<\/p><table><tbody><tr style=\"height: 24px;\"><td style=\"height: 24px;\"><strong> Type of License<\/strong><\/td><td style=\"height: 24px;\"> <strong>Description<\/strong><\/td><\/tr><tr style=\"height: 48px;\"><td style=\"height: 48px;\">Manufacturing license pursuant to \u00a7\u00a7 13, import license pursuant to \u00a7\u00a7 72 AMG<\/td><td style=\"height: 48px;\">Collection and import license issued by Saxon State Directorate (Landesdirektion Sachsen)<\/td><\/tr><tr style=\"height: 48px;\"><td style=\"height: 48px;\">Manufacturing (Deutscher Platz 5a), \u00a713 AMG (medicinal products for human use)<\/td><td style=\"height: 48px;\">Stem cells from umbilical cord blood, autologous and allogeneic blood, cryo-preserved, includes volume reduction (SEPAX method)<\/td><\/tr><tr style=\"height: 24px;\"><td style=\"height: 24px;\">Import license, \u00a7 72 AMG<\/td><td style=\"height: 24px;\">human cord blood from autologous blood (Switzerland\/Serbia)<\/td><\/tr><tr style=\"height: 48px;\"><td style=\"height: 48px;\">Manufacturing of investigational medicinal products, \u00a713 AMG<\/td><td style=\"height: 48px;\"> Stem cells from umbilical cord blood &#8211; autologous blood cryo-preserved for clinical investigation (limited to diabetes study, which is concluded already)<\/td><\/tr><tr style=\"height: 24px;\"><td style=\"height: 24px;\">Storage of preparations<\/td><td style=\"height: 24px;\"> <\/td><\/tr><tr style=\"height: 24px;\"><td style=\"height: 24px;\">Storage of preparations<\/td><td style=\"height: 24px;\"> <\/td><\/tr><tr style=\"height: 48px;\"><td style=\"height: 48px;\">Manufacturing license pursuant to \u00a7\u00a7 20b, 20c, 72b AMG<\/td><td style=\"height: 48px;\">License to collect tissue, process and prepare, preserve, and store tissue as well as import tissue<\/td><\/tr><tr style=\"height: 24px;\"><td style=\"height: 24px;\">Collection of tissue, \u00a7 20b AMG<\/td><td style=\"height: 24px;\">Human umbilical cord (autologous)<\/td><\/tr><tr style=\"height: 48px;\"><td style=\"height: 48px;\">Processing and preparation, preservation, and storage of tissue, \u00a7 20c AMG<\/td><td style=\"height: 48px;\">Human umbilical cord (autologous)<\/td><\/tr><tr style=\"height: 24px;\"><td style=\"height: 24px;\">Import license, \u00a7 72b AMG<\/td><td style=\"height: 24px;\">Human umbilical cord (autologous, Switzerland)<\/td><\/tr><\/tbody><\/table><p>In addition to the manufacturing\/import license pursuant to \u00a7\u00a7 13 and 72 AMG (German Medicinal Products Act) and the license to collect tissue, process and prepare, preserve, and store tissue as well as import tissue pursuant to \u00a7\u00a7 20b, 20c and 72b AMG and the related GMP certificate, Vita 34 AG owns permits and licenses issued by Paul Ehrlich Institute.<\/p><table style=\"width: 926px;\"><tbody><tr><td style=\"width: 308.867px;\">License as drug product<br \/> (allogeneic donation) pursuant to \u00a7 21 AMG<\/td><td style=\"width: 600.133px;\">Licenses and permits issued by Paul Ehrlich Institute <br \/>License no. \/ initial date of license (extension of license on April 13, 2015)<\/td><\/tr><tr><td style=\"width: 308.867px;\">Cord Blood VITA 34 &#8211; 2.5<\/td><td style=\"width: 600.133px;\">PEI.H.00601.02.1 \/ October 14, 2006<\/td><\/tr><tr><td style=\"width: 308.867px;\">Cord Blood VITA 34 &#8211; 5<\/td><td style=\"width: 600.133px;\">PEI.H.00601.01.1 \/ October 14, 2006<\/td><\/tr><tr><td style=\"width: 308.867px;\">Cord Blood VITA 34 mini<\/td><td style=\"width: 600.133px;\">PEI.H.00601.03.1 \/ December 20, 2007<\/td><\/tr><\/tbody><\/table><p>&nbsp;<\/p><table><tbody><tr><td>License on the application as directed donation pursuant to \u00a7 21a AMG<\/td><td><p>Permits and licenses issued by Paul Ehrlich Institute<br \/>License no.\/license date<\/p><\/td><\/tr><tr><td>Cord blood VITA 34-1 directed &#8211; allogeneic<\/td><td>PEI.G.04318.01.1 \/ August 2, 2011<\/td><\/tr><tr><td>Cord blood VITA 34-2 directed &#8211; allogeneic<\/td><td>PEI.G.04318.02.1 \/ August 2, 2011<\/td><\/tr><\/tbody><\/table><p>&nbsp;<\/p><table><tbody><tr><td>License on the application as autologous preparation pursuant to \u00a7 21a AMG<\/td><td><p>Permits and licenses issued by Paul Ehrlich Institute<br \/>License no.\/license date<\/p><\/td><\/tr><tr><td>Autologous cord blood VITA 34-1<\/td><td>PEI.G.03988.01.1 \/ January 12, 2012<\/td><\/tr><tr><td>Autologous cord blood VITA 34-2\/3<\/td><td>PEI.G.03988.02.1 \/ January 12, 2012<\/td><\/tr><\/tbody><\/table><div class=\"\"><p> Furthermore, cord blood Vita 34 was licensed as investigational medicinal product for the study on diabetes type 1 conducted by the University of Munich (ClinicalTrials.gov identifier: NCT00989547).<\/p><\/div><table><tbody><tr><td>Manufacturing license pursuant to the Austrian Tissue Safety Act (GSG)<\/td><td><p>Collection licenses issued by the Austrian Agency for Health and Food Safety (AGES) \/ date)<\/p><\/td><\/tr><tr><td>Manufacturing license \u00a719 (1) GSG<\/td><td>Collection of autologous umbilical cord blood \/ April 28, 2011<\/td><\/tr><tr><td>Manufacturing license \u00a7 19 (2) GSG<\/td><td>Expanded by collection of umbilical cord tissue \/ September 17, 2013<\/td><\/tr><tr><td>Manufacturing license \u00a7 19 (2) GSG<\/td><td>Expanded by collection of umbilical cord blood for allogeneic application \/ September 2, 2014<\/td><\/tr><\/tbody><\/table><div class=\"\"><p>&nbsp;<\/p><\/div>","protected":false},"excerpt":{"rendered":"<p>Vita 34 owns comprehensive permits, licenses, concessions, and accreditations.The compliance with the strictest quality standards is reflected in the various permits and licenses. In addition to the license concerning the [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"content-type":"","footnotes":""},"class_list":["post-12239","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Vita 34: Official licenses - permits granted by PEI (Paul Ehrlich Institute)<\/title>\n<meta name=\"description\" content=\"Vita 34 owns all the official licenses necessary to store and release preparations from umbilical cord blood and tissue safely.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.vita34.ch\/genehmigungen\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Vita 34: Official licenses - permits granted by PEI (Paul Ehrlich Institute)\" \/>\n<meta property=\"og:description\" content=\"Vita 34 owns all the official licenses necessary to store and release preparations from umbilical cord blood and tissue safely.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.vita34.ch\/genehmigungen\/\" \/>\n<meta property=\"og:site_name\" content=\"Vita34\" \/>\n<meta property=\"article:modified_time\" content=\"2016-08-30T10:47:08+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"3 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.vita34.ch\\\/genehmigungen\\\/\",\"url\":\"https:\\\/\\\/www.vita34.ch\\\/genehmigungen\\\/\",\"name\":\"Vita 34: Official licenses - permits granted by PEI (Paul Ehrlich Institute)\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.vita34.ch\\\/#website\"},\"datePublished\":\"2016-04-07T14:19:40+00:00\",\"dateModified\":\"2016-08-30T10:47:08+00:00\",\"description\":\"Vita 34 owns all the official licenses necessary to store and release preparations from umbilical cord blood and tissue safely.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/www.vita34.ch\\\/genehmigungen\\\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/www.vita34.ch\\\/genehmigungen\\\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/www.vita34.ch\\\/genehmigungen\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Startseite\",\"item\":\"https:\\\/\\\/www.vita34.ch\\\/en\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Permits\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/www.vita34.ch\\\/#website\",\"url\":\"https:\\\/\\\/www.vita34.ch\\\/\",\"name\":\"Vita34\",\"description\":\"Einlagerung von Stammzellen bei Vita 34 - die Stammzellbank\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/www.vita34.ch\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Vita 34: Official licenses - permits granted by PEI (Paul Ehrlich Institute)","description":"Vita 34 owns all the official licenses necessary to store and release preparations from umbilical cord blood and tissue safely.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.vita34.ch\/genehmigungen\/","og_locale":"en_US","og_type":"article","og_title":"Vita 34: Official licenses - permits granted by PEI (Paul Ehrlich Institute)","og_description":"Vita 34 owns all the official licenses necessary to store and release preparations from umbilical cord blood and tissue safely.","og_url":"https:\/\/www.vita34.ch\/genehmigungen\/","og_site_name":"Vita34","article_modified_time":"2016-08-30T10:47:08+00:00","twitter_card":"summary_large_image","twitter_misc":{"Est. reading time":"3 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/www.vita34.ch\/genehmigungen\/","url":"https:\/\/www.vita34.ch\/genehmigungen\/","name":"Vita 34: Official licenses - permits granted by PEI (Paul Ehrlich Institute)","isPartOf":{"@id":"https:\/\/www.vita34.ch\/#website"},"datePublished":"2016-04-07T14:19:40+00:00","dateModified":"2016-08-30T10:47:08+00:00","description":"Vita 34 owns all the official licenses necessary to store and release preparations from umbilical cord blood and tissue safely.","breadcrumb":{"@id":"https:\/\/www.vita34.ch\/genehmigungen\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.vita34.ch\/genehmigungen\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/www.vita34.ch\/genehmigungen\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Startseite","item":"https:\/\/www.vita34.ch\/en\/"},{"@type":"ListItem","position":2,"name":"Permits"}]},{"@type":"WebSite","@id":"https:\/\/www.vita34.ch\/#website","url":"https:\/\/www.vita34.ch\/","name":"Vita34","description":"Einlagerung von Stammzellen bei Vita 34 - die Stammzellbank","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.vita34.ch\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"}]}},"_links":{"self":[{"href":"https:\/\/www.vita34.ch\/en\/wp-json\/wp\/v2\/pages\/12239","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.vita34.ch\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.vita34.ch\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.vita34.ch\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.vita34.ch\/en\/wp-json\/wp\/v2\/comments?post=12239"}],"version-history":[{"count":0,"href":"https:\/\/www.vita34.ch\/en\/wp-json\/wp\/v2\/pages\/12239\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.vita34.ch\/en\/wp-json\/wp\/v2\/media?parent=12239"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}