{"id":169,"date":"2024-01-26T12:34:00","date_gmt":"2024-01-26T11:34:00","guid":{"rendered":"https:\/\/blogs.dlapiper.com\/paragraph\/?p=169"},"modified":"2024-09-06T17:14:26","modified_gmt":"2024-09-06T15:14:26","slug":"prevod-registrace-leciveho-pripravku-pri-ma-transakcich","status":"publish","type":"post","link":"https:\/\/blogs.dlapiper.com\/paragraph\/2024\/01\/prevod-registrace-leciveho-pripravku-pri-ma-transakcich\/","title":{"rendered":"P\u0159evod registrace l\u00e9\u010div\u00e9ho p\u0159\u00edpravku p\u0159i M&amp;A transakc\u00edch"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong><em>Minul\u00fd rok p\u0159inesl do farmaceutick\u00e9ho pr\u016fmyslu n\u011bkolik v\u00fdznamn\u00fdch zm\u011bn, mezi nimi\u017e vynik\u00e1 rostouc\u00ed trend f\u00faz\u00ed a akvizic. Tato situace potvrdila p\u0159edpov\u011bdi odborn\u00edk\u016f, kte\u0159\u00ed zd\u016fraz\u0148ovali, \u017ee p\u0159edev\u0161\u00edm velk\u00e9 farmaceutick\u00e9 spole\u010dnosti disponuj\u00ed v\u00fdznamn\u00fdmi finan\u010dn\u00edmi prost\u0159edky, je\u017e slou\u017e\u00ed jako pohon pro jejich akvizi\u010dn\u00ed aktivity. I proto, \u017ee \u010d\u00e1st t\u011bchto prost\u0159edk\u016f z\u016fstala v\u00a0lo\u0148sk\u00e9m roce nevyu\u017eita, lze p\u0159edpokl\u00e1dat, \u017ee rok 2024 bude pokra\u010dov\u00e1n\u00edm nastaven\u00e9ho trendu. M&amp;A transakce v \u010cesku v\u00a0sektoru life sciences, kam pat\u0159\u00ed i farmaceutick\u00fd pr\u016fmysl, mohou ale vyvolat ot\u00e1zku, zda registrace l\u00e9\u010div\u00e9ho p\u0159\u00edpravku automaticky p\u0159ech\u00e1z\u00ed na nabyvatele, respektive n\u00e1stupnickou spole\u010dnost, a jak\u00e9 kroky je t\u0159eba u\u010dinit ve vztahu k\u00a0regulatorn\u00edm \u00fa\u0159ad\u016f.<\/em><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Pokud se jedn\u00e1 o f\u00fazi, p\u0159evod (\u010d\u00e1sti) podniku \u010di jin\u00e9 p\u0159\u00edpady univerz\u00e1ln\u00ed sukcese, kdy p\u0159ech\u00e1zej\u00ed v\u0161echna pr\u00e1va a povinnosti z&nbsp;jedn\u00e9 z\u00fa\u010dastn\u011bn\u00e9 spole\u010dnosti na druhou z\u00fa\u010dastn\u011bnou spole\u010dnost, tak nov\u00fd dr\u017eitel rozhodnut\u00ed o registraci vstupuje automaticky do pr\u00e1v a povinnost\u00ed p\u0159ede\u0161l\u00e9ho dr\u017eitele rozhodnut\u00ed o registraci. Podle Na\u0159\u00edzen\u00ed Komise (ES) \u010d. 1234\/2008 ze dne 24. listopadu 2008 o posuzov\u00e1n\u00ed zm\u011bn registrac\u00ed hum\u00e1nn\u00edch a veterin\u00e1rn\u00edch l\u00e9\u010div\u00fdch p\u0159\u00edpravk\u016f je zm\u011bna dr\u017eitele rozhodnut\u00ed o registraci zm\u011bnou \u010dist\u011b administrativn\u00ed povahy, a je tedy klasifikov\u00e1na jako zm\u011bna typu IA.&nbsp; Zm\u011bny typu IA jsou mal\u00e9 zm\u011bny, kter\u00e9 maj\u00ed minim\u00e1ln\u00ed nebo v\u016fbec \u017e\u00e1dn\u00fd dopad na bezpe\u010dnost, \u00fa\u010dinnost nebo kvalitu l\u00e9\u010div\u00e9ho p\u0159\u00edpravku. Proto sta\u010d\u00ed zm\u011bnu dr\u017eitele rozhodnut\u00ed o registraci ozn\u00e1mit St\u00e1tn\u00edmu \u00fastavu pro kontrolu l\u00e9\u010div a\u017e n\u00e1sledn\u011b, tedy po dokon\u010den\u00ed obchodn\u00ed transakce.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">V&nbsp;t\u011bchto p\u0159\u00edpadech se postupuje podle \u00a7 35 z\u00e1kona \u010d. 378\/2007 Sb., o l\u00e9\u010divech, ve zn\u011bn\u00ed pozd\u011bj\u0161\u00edch p\u0159edpis\u016f (\u201eZ\u00e1kon\u201c), kter\u00fd upravuje \u201ezm\u011bny registrace\u201c. \u017d\u00e1dost se pod\u00e1v\u00e1 na standardn\u00edm formul\u00e1\u0159i, a to do 12 m\u011bs\u00edc\u016f po uskute\u010dn\u011bn\u00ed transakce. Pokud se st\u00e1vaj\u00edc\u00ed dr\u017eitel rozhodne zm\u011bnu ohl\u00e1sit p\u0159edem, pak lze zm\u011bnu registrace implementovat do 6 m\u011bs\u00edc\u016f od p\u0159edpokl\u00e1dan\u00e9ho schv\u00e1len\u00ed zm\u011bny.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Jin\u00fd postup se uplatn\u00ed p\u0159i p\u0159evodu registrace l\u00e9\u010div\u00e9ho p\u0159\u00edpravku jako\u017eto izolovan\u00e9ho majetku (tzv. asset deal).&nbsp; V&nbsp;t\u011bchto p\u0159\u00edpadech st\u00e1vaj\u00edc\u00ed dr\u017eitel rozhodnut\u00ed o registraci mus\u00ed p\u0159edlo\u017eit St\u00e1tn\u00edmu \u00fastavu pro kontrolu l\u00e9\u010div \u017e\u00e1dost o p\u0159evod registrace na jinou osobu podle \u00a7 36 Z\u00e1kona. I tato \u017e\u00e1dost se pod\u00e1v\u00e1 na standardizovan\u00e9m formul\u00e1\u0159i, p\u0159i\u010dem\u017e pro ka\u017ed\u00e9 registra\u010dn\u00ed \u010d\u00edslo l\u00e9\u010div\u00e9ho p\u0159\u00edpravku je nutno podat samostatnou \u017e\u00e1dost. V \u017e\u00e1dosti mus\u00ed b\u00fdt krom\u011b jin\u00e9ho uvedeno datum, ke kter\u00e9mu m\u00e1 b\u00fdt p\u0159evod registrace uskute\u010dn\u011bn. \u017d\u00e1dost mus\u00ed b\u00fdt dolo\u017eena souhlasem osoby, na kterou m\u00e1 b\u00fdt registrace p\u0159evedena. St\u00e1tn\u00ed \u00fastav pro kontrolu l\u00e9\u010div o \u017e\u00e1dosti rozhodne do 30 dn\u016f, p\u0159i\u010dem\u017e ji m\u016f\u017ee zam\u00edtnout pouze pokud (a) \u00fadaje a dokumentace p\u0159edlo\u017een\u00e9 s \u017e\u00e1dost\u00ed jsou i po v\u00fdzv\u011b k dopln\u011bn\u00ed ne\u00fapln\u00e9 nebo jinak vadn\u00e9, nebo (b) osoba, na kterou se registrace m\u00e1 p\u0159ev\u00e9st, nem\u00e1 bydli\u0161t\u011b nebo nen\u00ed usazena na \u00fazem\u00ed n\u011bkter\u00e9ho z \u010dlensk\u00fdch st\u00e1t\u016f EU. V rozhodnut\u00ed je pak uveden den, ke kter\u00e9mu se p\u0159evod registrace uskute\u010dn\u00ed. Rozhodnut\u00ed pak zas\u00edl\u00e1 st\u00e1vaj\u00edc\u00edmu i navrhovan\u00e9mu dr\u017eiteli.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">V&nbsp;obou p\u0159\u00edpadech lze l\u00e9\u010div\u00fd p\u0159\u00edpravek odpov\u00eddaj\u00edc\u00ed \u00fadaj\u016fm a dokumentaci p\u0159ed proveden\u00edm zm\u011bny\/p\u0159evodu registrace, pokud nebylo v rozhodnut\u00ed o zm\u011bn\u011b\/p\u0159evodu registrace stanoveno jinak, nad\u00e1le uv\u00e1d\u011bt na trh nejd\u00e9le po dobu 180 dn\u016f od schv\u00e1len\u00ed zm\u011bny\/dne p\u0159evodu registrace. Distribuovat, vyd\u00e1vat, v p\u0159\u00edpad\u011b vyhrazen\u00fdch l\u00e9\u010div\u00fdch p\u0159\u00edpravk\u016f prod\u00e1vat, a pou\u017e\u00edvat p\u0159i poskytov\u00e1n\u00ed zdravotn\u00edch slu\u017eeb je takov\u00fd l\u00e9\u010div\u00fd p\u0159\u00edpravek mo\u017en\u00e9 d\u00e1le po dobu jeho pou\u017eitelnosti.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\" \/>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Minul\u00fd rok p\u0159inesl do farmaceutick\u00e9ho pr\u016fmyslu n\u011bkolik v\u00fdznamn\u00fdch zm\u011bn, mezi nimi\u017e vynik\u00e1 rostouc\u00ed trend f\u00faz\u00ed a akvizic. Tato situace potvrdila p\u0159edpov\u011bdi odborn\u00edk\u016f, kte\u0159\u00ed zd\u016fraz\u0148ovali, \u017ee p\u0159edev\u0161\u00edm velk\u00e9 farmaceutick\u00e9 spole\u010dnosti disponuj\u00ed v\u00fdznamn\u00fdmi finan\u010dn\u00edmi prost\u0159edky, je\u017e slou\u017e\u00ed jako pohon pro jejich akvizi\u010dn\u00ed aktivity. I proto, \u017ee \u010d\u00e1st t\u011bchto prost\u0159edk\u016f z\u016fstala v\u00a0lo\u0148sk\u00e9m roce nevyu\u017eita, lze p\u0159edpokl\u00e1dat, \u017ee rok [&hellip;]<\/p>\n","protected":false},"author":791,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[28,46],"tags":[],"coauthors":[44,39],"class_list":["post-169","post","type-post","status-publish","format-standard","hentry","category-corporate","category-life-science"],"_links":{"self":[{"href":"https:\/\/blogs.dlapiper.com\/paragraph\/wp-json\/wp\/v2\/posts\/169","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.dlapiper.com\/paragraph\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.dlapiper.com\/paragraph\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.dlapiper.com\/paragraph\/wp-json\/wp\/v2\/users\/791"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.dlapiper.com\/paragraph\/wp-json\/wp\/v2\/comments?post=169"}],"version-history":[{"count":0,"href":"https:\/\/blogs.dlapiper.com\/paragraph\/wp-json\/wp\/v2\/posts\/169\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.dlapiper.com\/paragraph\/wp-json\/wp\/v2\/media?parent=169"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.dlapiper.com\/paragraph\/wp-json\/wp\/v2\/categories?post=169"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.dlapiper.com\/paragraph\/wp-json\/wp\/v2\/tags?post=169"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.dlapiper.com\/paragraph\/wp-json\/wp\/v2\/coauthors?post=169"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}