{"id":6940,"date":"2025-09-03T09:11:25","date_gmt":"2025-09-03T07:11:25","guid":{"rendered":"https:\/\/fgk-group.com\/?post_type=news-events-news&p=6940"},"modified":"2025-11-20T12:02:10","modified_gmt":"2025-11-20T11:02:10","slug":"is-your-company-based-in-the-uk","status":"publish","type":"news-events-news","link":"https:\/\/fgk-group.com\/de\/news-konferenzen\/news\/is-your-company-based-in-the-uk\/","title":{"rendered":"Is your company based in the UK?"},"content":{"rendered":"\t\t
\n\t\t\t\t
\n\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t07\/Feb\/19\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t

Is your company based in the UK?<\/h1>\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t

Here\u2019s how to prepare for Brexit regarding Pharmacovigilance\/QPPV and Legal Representative requirements<\/span><\/strong><\/p>

Following two years of negotiations between the UK and the EU, the UK Parliament voted against the Brexit deal. If your company is based in UK, this may have profound impact on your clinical research programme and\/or the marketing status of your medicinal product\/s:\u00a0<\/b><\/p>

The European Medicines Agency (EMA)\u00a0expects UK based companies to pro-actively prepare<\/a><\/strong>\u00a0 in order to avoid any disruptions in March 2019.<\/p>

Get on board with FGK and start working with a company that is already operating on the continent!<\/p>

Our Pharmacovigilance services for UK companies:<\/span><\/strong><\/p>

Marketing Authorization Applicants\/Holders in the European Union are legally obliged to appoint a \u201cQualified Person for Pharmacovigilance (QPPV)\u201d within the EEA and also locate their \u201cPharmacovigilance System Master File (PSMF)\u201d there. After the Brexit, this will apply to all UK companies having their QPPV \/ PSMF within the UK.<\/p>

For more information about the services of \u201cFGK Pharmacovigilance GmbH<\/a><\/strong>\u201d\u00a0 please contact us directly:\u00a0info@fgk-pv.com<\/strong><\/a><\/p>

Our Legal Representative services for UK companies:<\/span><\/strong><\/p>

Sponsor companies that are not based in the EU\/EEA must appoint a legal representative when conducting clinical trials in the EU\/EEA. After the Brexit this will apply to UK companies planning to continue their clinical trial activities outside the UK, in the EU.<\/p>

\u201cFGK Representative Service BV<\/a><\/strong>\u201d can assist you by offering and providing the legal representation in the EU\/EEA for you. Get in touch with us:\u00a0 info@fgk-rs.com<\/a><\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

Here\u2019s how to prepare for Brexit regarding Pharmacovigilance\/QPPV and Legal Representative requirements<\/p>\n

Following two years of negotiations between\u2026<\/p>\n","protected":false},"template":"","class_list":["post-6940","news-events-news","type-news-events-news","status-publish","hentry"],"yoast_head":"\nIs your company based in the UK? - FGK Group<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/fgk-group.com\/de\/news-konferenzen\/news\/is-your-company-based-in-the-uk\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Is your company based in the UK? - FGK Group\" \/>\n<meta property=\"og:description\" content=\"Here\u2019s how to prepare for Brexit regarding Pharmacovigilance\/QPPV and Legal Representative requirements Following two years of negotiations between\u2026\" \/>\n<meta property=\"og:url\" content=\"https:\/\/fgk-group.com\/de\/news-konferenzen\/news\/is-your-company-based-in-the-uk\/\" \/>\n<meta property=\"og:site_name\" content=\"FGK Group\" \/>\n<meta property=\"article:modified_time\" content=\"2025-11-20T11:02:10+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Gesch\u00e4tzte Lesezeit\" \/>\n\t<meta name=\"twitter:data1\" content=\"2\u00a0Minuten\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/fgk-group.com\\\/de\\\/news-konferenzen\\\/news\\\/is-your-company-based-in-the-uk\\\/\",\"url\":\"https:\\\/\\\/fgk-group.com\\\/de\\\/news-konferenzen\\\/news\\\/is-your-company-based-in-the-uk\\\/\",\"name\":\"Is your company based in the UK? - FGK Group\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/fgk-group.com\\\/de\\\/#website\"},\"datePublished\":\"2025-09-03T07:11:25+00:00\",\"dateModified\":\"2025-11-20T11:02:10+00:00\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/fgk-group.com\\\/de\\\/news-konferenzen\\\/news\\\/is-your-company-based-in-the-uk\\\/#breadcrumb\"},\"inLanguage\":\"de\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/fgk-group.com\\\/de\\\/news-konferenzen\\\/news\\\/is-your-company-based-in-the-uk\\\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/fgk-group.com\\\/de\\\/news-konferenzen\\\/news\\\/is-your-company-based-in-the-uk\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/fgk-group.com\\\/de\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"News\",\"item\":\"https:\\\/\\\/fgk-group.com\\\/de\\\/news-konferenzen\\\/news\\\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"Is your company based in the UK?\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/fgk-group.com\\\/de\\\/#website\",\"url\":\"https:\\\/\\\/fgk-group.com\\\/de\\\/\",\"name\":\"FGK Group\",\"description\":\"Just another WordPress site\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/fgk-group.com\\\/de\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"de\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Is your company based in the UK? - FGK Group","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:\/\/fgk-group.com\/de\/news-konferenzen\/news\/is-your-company-based-in-the-uk\/","og_locale":"de_DE","og_type":"article","og_title":"Is your company based in the UK? - FGK Group","og_description":"Here\u2019s how to prepare for Brexit regarding Pharmacovigilance\/QPPV and Legal Representative requirements Following two years of negotiations between\u2026","og_url":"https:\/\/fgk-group.com\/de\/news-konferenzen\/news\/is-your-company-based-in-the-uk\/","og_site_name":"FGK Group","article_modified_time":"2025-11-20T11:02:10+00:00","twitter_card":"summary_large_image","twitter_misc":{"Gesch\u00e4tzte Lesezeit":"2\u00a0Minuten"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/fgk-group.com\/de\/news-konferenzen\/news\/is-your-company-based-in-the-uk\/","url":"https:\/\/fgk-group.com\/de\/news-konferenzen\/news\/is-your-company-based-in-the-uk\/","name":"Is your company based in the UK? - FGK Group","isPartOf":{"@id":"https:\/\/fgk-group.com\/de\/#website"},"datePublished":"2025-09-03T07:11:25+00:00","dateModified":"2025-11-20T11:02:10+00:00","breadcrumb":{"@id":"https:\/\/fgk-group.com\/de\/news-konferenzen\/news\/is-your-company-based-in-the-uk\/#breadcrumb"},"inLanguage":"de","potentialAction":[{"@type":"ReadAction","target":["https:\/\/fgk-group.com\/de\/news-konferenzen\/news\/is-your-company-based-in-the-uk\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/fgk-group.com\/de\/news-konferenzen\/news\/is-your-company-based-in-the-uk\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/fgk-group.com\/de\/"},{"@type":"ListItem","position":2,"name":"News","item":"https:\/\/fgk-group.com\/de\/news-konferenzen\/news\/"},{"@type":"ListItem","position":3,"name":"Is your company based in the UK?"}]},{"@type":"WebSite","@id":"https:\/\/fgk-group.com\/de\/#website","url":"https:\/\/fgk-group.com\/de\/","name":"FGK Group","description":"Just another WordPress site","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/fgk-group.com\/de\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"de"}]}},"_links":{"self":[{"href":"https:\/\/fgk-group.com\/de\/wp-json\/wp\/v2\/news-events-news\/6940","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/fgk-group.com\/de\/wp-json\/wp\/v2\/news-events-news"}],"about":[{"href":"https:\/\/fgk-group.com\/de\/wp-json\/wp\/v2\/types\/news-events-news"}],"version-history":[{"count":4,"href":"https:\/\/fgk-group.com\/de\/wp-json\/wp\/v2\/news-events-news\/6940\/revisions"}],"predecessor-version":[{"id":6945,"href":"https:\/\/fgk-group.com\/de\/wp-json\/wp\/v2\/news-events-news\/6940\/revisions\/6945"}],"wp:attachment":[{"href":"https:\/\/fgk-group.com\/de\/wp-json\/wp\/v2\/media?parent=6940"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}