{"id":61603,"date":"2023-12-08T20:25:38","date_gmt":"2023-12-08T11:25:38","guid":{"rendered":"https:\/\/monolith.law\/cs\/?p=61603"},"modified":"2024-03-30T14:08:43","modified_gmt":"2024-03-30T05:08:43","slug":"medical-equipment-regulation","status":"publish","type":"post","link":"https:\/\/monolith.law\/cs\/general-corporate\/medical-equipment-regulation","title":{"rendered":"Regulace t\u00fdkaj\u00edc\u00ed se reklamy na zdravotnick\u00e9 prost\u0159edky: Co je to 'Japonsk\u00fd z\u00e1kon o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch'?"},"content":{"rendered":"\n<p>Existuje mnoho druh\u016f zdravotnick\u00fdch prost\u0159edk\u016f. N\u011bkter\u00e9 z nich mohou m\u00edt velk\u00fd vliv na na\u0161e t\u011blo a zdrav\u00ed.<\/p>\n\n\n\n<p>Pokud dojde k nevhodn\u00e9mu um\u00edst\u011bn\u00ed reklamy na takov\u00e9 zdravotnick\u00e9 prost\u0159edky, existuje riziko, \u017ee lid\u00e9, kte\u0159\u00ed v\u011b\u0159\u00ed obsahu t\u00e9to nevhodn\u00e9 reklamy, zakoup\u00ed zdravotnick\u00fd prost\u0159edek a v d\u016fsledku jeho pou\u017eit\u00ed m\u016f\u017ee doj\u00edt k v\u00e1\u017en\u00fdm zdravotn\u00edm \u0161kod\u00e1m.<\/p>\n\n\n\n<p>Proto je um\u00edst\u011bn\u00ed reklamy na zdravotnick\u00e9 prost\u0159edky regulov\u00e1no z\u00e1konem o zaji\u0161t\u011bn\u00ed kvality, \u00fa\u010dinnosti a bezpe\u010dnosti l\u00e9\u010div, zdravotnick\u00fdch prost\u0159edk\u016f atd. (d\u00e1le jen &#8220;z\u00e1kon o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch&#8221;).<\/p>\n\n\n\n<p>V tomto \u010dl\u00e1nku p\u0159edstav\u00edme pr\u00e1vn\u00ed regulaci reklamy na zdravotnick\u00e9 prost\u0159edky pro podnikatele, kte\u0159\u00ed uva\u017euj\u00ed o um\u00edst\u011bn\u00ed reklamy na zdravotnick\u00e9 prost\u0159edky.<\/p>\n\n\n\n<p><a href=\"https:\/\/monolith.law\/corporate\/medical-supplies-law\" target=\"_blank\" rel=\"noreferrer noopener\">https:\/\/monolith.law\/corporate\/medical-supplies-law[ja]<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/monolith.law\/corporate\/cbd-ad-pmd-restriction\" target=\"_blank\" rel=\"noreferrer noopener\">https:\/\/monolith.law\/corporate\/cbd-ad-pmd-restriction[ja]<\/a><\/p>\n\n\n\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_53 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<span class=\"ez-toc-title-toggle\"><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/monolith.law\/cs\/general-corporate\/medical-equipment-regulation\/#Regulace_reklamy_na_zdravotnicke_prostredky_stanovene_v_Japonskem_zakone_o_lecivech_a_zdravotnickych_prostredcich_%E8%96%AC%E6%A9%9F%E6%B3%95\" title=\"Regulace reklamy na zdravotnick\u00e9 prost\u0159edky stanoven\u00e9 v Japonsk\u00e9m z\u00e1kon\u011b o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch (\u85ac\u6a5f\u6cd5)\">Regulace reklamy na zdravotnick\u00e9 prost\u0159edky stanoven\u00e9 v Japonsk\u00e9m z\u00e1kon\u011b o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch (\u85ac\u6a5f\u6cd5)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/monolith.law\/cs\/general-corporate\/medical-equipment-regulation\/#Pravni_definice_lekarskych_zarizeni\" title=\"Pr\u00e1vn\u00ed definice l\u00e9ka\u0159sk\u00fdch za\u0159\u00edzen\u00ed\">Pr\u00e1vn\u00ed definice l\u00e9ka\u0159sk\u00fdch za\u0159\u00edzen\u00ed<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/monolith.law\/cs\/general-corporate\/medical-equipment-regulation\/#Regulace_reklamnich_projevu_na_zdravotnicke_pristroje\" title=\"Regulace reklamn\u00edch projev\u016f na zdravotnick\u00e9 p\u0159\u00edstroje\">Regulace reklamn\u00edch projev\u016f na zdravotnick\u00e9 p\u0159\u00edstroje<\/a><ul class='ez-toc-list-level-3'><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/monolith.law\/cs\/general-corporate\/medical-equipment-regulation\/#Relevance_%E2%80%9CReklamy%E2%80%9D\" title=\"Relevance &#8220;Reklamy&#8221;\">Relevance &#8220;Reklamy&#8221;<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/monolith.law\/cs\/general-corporate\/medical-equipment-regulation\/#O_subjektech_na_ktere_se_vztahuje_regulace_reklamy_na_zdravotnicke_prostredky\" title=\"O subjektech, na kter\u00e9 se vztahuje regulace reklamy na zdravotnick\u00e9 prost\u0159edky\">O subjektech, na kter\u00e9 se vztahuje regulace reklamy na zdravotnick\u00e9 prost\u0159edky<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/monolith.law\/cs\/general-corporate\/medical-equipment-regulation\/#Jake_vyrazy_jsou_predmetem_regulace\" title=\"Jak\u00e9 v\u00fdrazy jsou p\u0159edm\u011btem regulace?\">Jak\u00e9 v\u00fdrazy jsou p\u0159edm\u011btem regulace?<\/a><ul class='ez-toc-list-level-4'><li class='ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/monolith.law\/cs\/general-corporate\/medical-equipment-regulation\/#Zakaz_prehnane_reklamy_na_zdravotnicke_prostredky_clanek_66\" title=\"Z\u00e1kaz p\u0159ehnan\u00e9 reklamy na zdravotnick\u00e9 prost\u0159edky (\u010dl\u00e1nek 66)\">Z\u00e1kaz p\u0159ehnan\u00e9 reklamy na zdravotnick\u00e9 prost\u0159edky (\u010dl\u00e1nek 66)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/monolith.law\/cs\/general-corporate\/medical-equipment-regulation\/#Zakaz_reklamy_na_zdravotnicke_prostredky_pred_jejich_schvalenim_clanek_68\" title=\"Z\u00e1kaz reklamy na zdravotnick\u00e9 prost\u0159edky p\u0159ed jejich schv\u00e1len\u00edm (\u010dl\u00e1nek 68)\">Z\u00e1kaz reklamy na zdravotnick\u00e9 prost\u0159edky p\u0159ed jejich schv\u00e1len\u00edm (\u010dl\u00e1nek 68)<\/a><\/li><\/ul><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/monolith.law\/cs\/general-corporate\/medical-equipment-regulation\/#Shrnuti\" title=\"Shrnut\u00ed\">Shrnut\u00ed<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/monolith.law\/cs\/general-corporate\/medical-equipment-regulation\/#Uvod_do_opatreni_nasi_kancelare\" title=\"\u00davod do opat\u0159en\u00ed na\u0161\u00ed kancel\u00e1\u0159e\">\u00davod do opat\u0159en\u00ed na\u0161\u00ed kancel\u00e1\u0159e<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Regulace_reklamy_na_zdravotnicke_prostredky_stanovene_v_Japonskem_zakone_o_lecivech_a_zdravotnickych_prostredcich_%E8%96%AC%E6%A9%9F%E6%B3%95\"><\/span>Regulace reklamy na zdravotnick\u00e9 prost\u0159edky stanoven\u00e9 v Japonsk\u00e9m z\u00e1kon\u011b o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch (\u85ac\u6a5f\u6cd5)<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Japonsk\u00fd z\u00e1kon o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch (\u85ac\u6a5f\u6cd5) stanovuje n\u00e1sleduj\u00edc\u00ed regulace t\u00fdkaj\u00edc\u00ed se reklamy na zdravotnick\u00e9 prost\u0159edky za \u00fa\u010delem zaji\u0161t\u011bn\u00ed kvality, \u00fa\u010dinnosti a bezpe\u010dnosti zdravotnick\u00fdch prost\u0159edk\u016f a prevence vzniku a \u0161\u00ed\u0159en\u00ed zdravotn\u00edch rizik spojen\u00fdch s pou\u017e\u00edv\u00e1n\u00edm zdravotnick\u00fdch prost\u0159edk\u016f:<\/p>\n\n\n\n<ul>\n<li>Z\u00e1kaz p\u0159ehnan\u00e9 reklamy atd. (\u010dl\u00e1nek 66)<\/li>\n\n\n\n<li>Z\u00e1kaz reklamy na zdravotnick\u00e9 prost\u0159edky p\u0159ed jejich schv\u00e1len\u00edm (\u010dl\u00e1nek 68)<\/li>\n<\/ul>\n\n\n\n<p>N\u00ed\u017ee podrobn\u011bji vysv\u011btl\u00edme regulace reklamy na zdravotnick\u00e9 prost\u0159edky stanoven\u00e9 v Japonsk\u00e9m z\u00e1kon\u011b o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch (\u85ac\u6a5f\u6cd5).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Pravni_definice_lekarskych_zarizeni\"><\/span>Pr\u00e1vn\u00ed definice l\u00e9ka\u0159sk\u00fdch za\u0159\u00edzen\u00ed<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full\"><img decoding=\"async\" src=\"https:\/\/monolith.law\/wp-content\/uploads\/2022\/05\/medical-equipment-regulation4.jpg\" alt=\"\" class=\"wp-image-45031\" \/><\/figure><\/div>\n\n\n<p>Definice &#8220;l\u00e9ka\u0159sk\u00fdch za\u0159\u00edzen\u00ed&#8221; je stanovena v n\u00e1sleduj\u00edc\u00edm \u010dl\u00e1nku 2 odstavec 4 japonsk\u00e9ho z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch (Japanese Pharmaceutical and Medical Device Act).<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>(Definice)<br>V tomto z\u00e1kon\u011b se &#8220;l\u00e9ka\u0159sk\u00fdm za\u0159\u00edzen\u00edm&#8221; rozum\u00ed stroje a n\u00e1stroje, kter\u00e9 jsou ur\u010deny k pou\u017eit\u00ed pro diagnostiku, l\u00e9\u010dbu nebo prevenci nemoc\u00ed u lid\u00ed nebo zv\u00ed\u0159at, nebo k ovlivn\u011bn\u00ed struktury nebo funkce t\u011bla lid\u00ed nebo zv\u00ed\u0159at (s v\u00fdjimkou produkt\u016f pro regenerativn\u00ed medic\u00ednu atd.), jak je stanoveno vl\u00e1dn\u00edm na\u0159\u00edzen\u00edm.<\/p>\n<\/blockquote>\n\n\n\n<p>Z v\u00fd\u0161e uveden\u00e9 definice vypl\u00fdv\u00e1, \u017ee aby bylo mo\u017en\u00e9 ozna\u010dit n\u011bco jako &#8220;l\u00e9ka\u0159sk\u00e9 za\u0159\u00edzen\u00ed&#8221;, mus\u00ed spl\u0148ovat jednu z n\u00e1sleduj\u00edc\u00edch podm\u00ednek:<\/p>\n\n\n\n<ul>\n<li>Pou\u017e\u00edv\u00e1 se k diagnostice, l\u00e9\u010db\u011b nebo prevenci nemoc\u00ed u lid\u00ed nebo zv\u00ed\u0159at<\/li>\n\n\n\n<li>Je ur\u010deno k ovlivn\u011bn\u00ed struktury nebo funkce t\u011bla lid\u00ed nebo zv\u00ed\u0159at<\/li>\n<\/ul>\n\n\n\n<p>Je t\u0159eba poznamenat, \u017ee produkty pro regenerativn\u00ed medic\u00ednu atd. jsou vylou\u010deny z definice &#8220;l\u00e9ka\u0159sk\u00fdch za\u0159\u00edzen\u00ed&#8221;, tak\u017ee se na n\u011b tento term\u00edn nevztahuje.<\/p>\n\n\n\n<p>Mezi konkr\u00e9tn\u00ed p\u0159\u00edklady l\u00e9ka\u0159sk\u00fdch za\u0159\u00edzen\u00ed, kter\u00e9 jsou b\u011b\u017enou sou\u010d\u00e1st\u00ed na\u0161eho \u017eivota, pat\u0159\u00ed teplom\u011bry, tlakom\u011bry, kontaktn\u00ed \u010do\u010dky atd.<\/p>\n\n\n\n<p>Za\u0159\u00edzen\u00ed jako AED (automatizovan\u00fd extern\u00ed defibril\u00e1tor) jsou tak\u00e9 pova\u017eov\u00e1ny za l\u00e9ka\u0159sk\u00e1 za\u0159\u00edzen\u00ed.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Regulace_reklamnich_projevu_na_zdravotnicke_pristroje\"><\/span>Regulace reklamn\u00edch projev\u016f na zdravotnick\u00e9 p\u0159\u00edstroje<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full\"><img decoding=\"async\" src=\"https:\/\/monolith.law\/wp-content\/uploads\/2022\/05\/medical-equipment-regulation2.jpg\" alt=\"\" class=\"wp-image-45028\" \/><\/figure><\/div>\n\n\n<p>Regulace reklamn\u00edch projev\u016f t\u00fdkaj\u00edc\u00edch se zdravotnick\u00fdch p\u0159\u00edstroj\u016f, jak bylo uvedeno v\u00fd\u0161e, se vztahuje na p\u0159ehnanou reklamu a reklamu na zdravotnick\u00e9 p\u0159\u00edstroje p\u0159ed jejich schv\u00e1len\u00edm.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Relevance_%E2%80%9CReklamy%E2%80%9D\"><\/span>Relevance &#8220;Reklamy&#8221;<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>V r\u00e1mci japonsk\u00e9ho &#8220;Z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch&#8221; (Pharmaceutical and Medical Device Act) nejsou pro term\u00edn &#8220;reklama&#8221; stanoveny \u017e\u00e1dn\u00e9 definice, podobn\u011b jako pro &#8220;zdravotnick\u00e9 prost\u0159edky&#8221;.<\/p>\n\n\n\n<p>Av\u0161ak, term\u00edn &#8220;reklama&#8221; je pou\u017eit v ustanoven\u00edch tohoto z\u00e1kona a pokud nev\u00edme, co p\u0159esn\u011b pod &#8220;reklamou&#8221; spad\u00e1, nem\u016f\u017eeme rozhodnout o tom, zda se z\u00e1kon vztahuje \u010di ne.<\/p>\n\n\n\n<p>Proto je t\u0159eba p\u0159em\u00fd\u0161let o v\u00fdznamu &#8220;reklamy&#8221;.<\/p>\n\n\n\n<p>Krit\u00e9ria pro &#8220;reklamu&#8221; v r\u00e1mci japonsk\u00e9ho &#8220;Z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch&#8221; byla zve\u0159ejn\u011bna v n\u00e1sleduj\u00edc\u00edm &#8220;Ozn\u00e1men\u00ed o relevanci reklamy na l\u00e9ky atd. podle z\u00e1kona o l\u00e9\u010divech&#8221; (Ozn\u00e1men\u00ed \u0159editele odd\u011blen\u00ed dohledu a pokyn\u016f pro bezpe\u010dnost l\u00e9k\u016f Ministerstva zdravotnictv\u00ed, pr\u00e1ce a soci\u00e1ln\u00edch v\u011bc\u00ed \u010d. 148 ze dne 29. z\u00e1\u0159\u00ed 1998 (rok 10 \u00e9ry Heisei, 1998 v gregori\u00e1nsk\u00e9m kalend\u00e1\u0159i) adresovan\u00e9 prefektur\u00e1ln\u00edm \u0159editel\u016fm odd\u011blen\u00ed hygieny).<\/p>\n\n\n\n<p>Konkr\u00e9tn\u011b, pokud jsou spln\u011bna n\u00e1sleduj\u00edc\u00ed t\u0159i krit\u00e9ria, je to pova\u017eov\u00e1no za &#8220;reklamu&#8221;:<\/p>\n\n\n\n<ul>\n<li>Je jasn\u011b zam\u00fd\u0161leno p\u0159il\u00e1kat z\u00e1kazn\u00edky (zv\u00fd\u0161it jejich touhu koupit)<\/li>\n\n\n\n<li>N\u00e1zev zdravotnick\u00e9ho prost\u0159edku je jasn\u011b uveden<\/li>\n\n\n\n<li>Je to ve stavu, kter\u00fd m\u016f\u017ee b\u00fdt rozpozn\u00e1n ve\u0159ejnost\u00ed<\/li>\n<\/ul>\n\n\n\n<p><a href=\"https:\/\/www.mhlw.go.jp\/bunya\/iyakuhin\/koukokukisei\/dl\/index_d.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">https:\/\/www.mhlw.go.jp\/bunya\/iyakuhin\/koukokukisei\/dl\/index_d.pdf[ja]<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"O_subjektech_na_ktere_se_vztahuje_regulace_reklamy_na_zdravotnicke_prostredky\"><\/span>O subjektech, na kter\u00e9 se vztahuje regulace reklamy na zdravotnick\u00e9 prost\u0159edky<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Je d\u016fle\u017eit\u00e9 si uv\u011bdomit, \u017ee regulace reklamy na zdravotnick\u00e9 prost\u0159edky se vztahuje na v\u0161echny subjekty bez omezen\u00ed, tedy na ka\u017ed\u00e9ho, kdo je jej\u00edm c\u00edlem.<\/p>\n\n\n\n<p>To znamen\u00e1, \u017ee i kdy\u017e nejste provozovatelem, kter\u00fd prod\u00e1v\u00e1 zdravotnick\u00e9 prost\u0159edky, pokud prov\u00e1d\u00edte reklamu na zdravotnick\u00e9 prost\u0159edky, budete podl\u00e9hat regulaci podle japonsk\u00e9ho z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch (Japanese Pharmaceutical and Medical Device Act).<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Jake_vyrazy_jsou_predmetem_regulace\"><\/span>Jak\u00e9 v\u00fdrazy jsou p\u0159edm\u011btem regulace?<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Jak ji\u017e bylo zm\u00edn\u011bno, p\u0159edm\u011btem regulace podle Japonsk\u00e9ho z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch (Pharmaceutical and Medical Device Act) jsou z\u00e1kazy p\u0159ehnan\u00e9 reklamy (\u010dl\u00e1nek 66) a reklamy na zdravotnick\u00e9 prost\u0159edky p\u0159ed jejich schv\u00e1len\u00edm (\u010dl\u00e1nek 68).<\/p>\n\n\n\n<p>N\u00ed\u017ee podrobn\u011b vysv\u011btl\u00edme ka\u017ed\u00fd z t\u011bchto reklamn\u00edch p\u0159edpis\u016f.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Zakaz_prehnane_reklamy_na_zdravotnicke_prostredky_clanek_66\"><\/span>Z\u00e1kaz p\u0159ehnan\u00e9 reklamy na zdravotnick\u00e9 prost\u0159edky (\u010dl\u00e1nek 66)<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p>\u010cl\u00e1nek 66 Japonsk\u00e9ho z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch stanovuje z\u00e1kaz p\u0159ehnan\u00e9 reklamy na zdravotnick\u00e9 prost\u0159edky n\u00e1sledovn\u011b:<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>(P\u0159ehnan\u00e1 reklama atd.)<br>\u010cl\u00e1nek 66 Nikdo nesm\u00ed inzerovat, popisovat nebo \u0161\u00ed\u0159it l\u017eiv\u00e9 nebo p\u0159ehnan\u00e9 informace o n\u00e1zvu, v\u00fdrobn\u00edm postupu, \u00fa\u010dinnosti, \u00fa\u010dinc\u00edch nebo vlastnostech l\u00e9k\u016f, l\u00e9k\u016f mimo l\u00e9k\u00e1rny, kosmetiky, zdravotnick\u00fdch prost\u0159edk\u016f nebo produkt\u016f regenerativn\u00ed medic\u00edny, a\u0165 u\u017e jsou tyto informace explicitn\u00ed nebo implicitn\u00ed.<br>2 Inzerov\u00e1n\u00ed, popisov\u00e1n\u00ed nebo \u0161\u00ed\u0159en\u00ed informac\u00ed, kter\u00e9 by mohly v\u00e9st k nedorozum\u011bn\u00ed, \u017ee l\u00e9ka\u0159 nebo jin\u00e1 osoba zaru\u010duje \u00fa\u010dinnost, \u00fa\u010dinky nebo vlastnosti l\u00e9k\u016f, l\u00e9k\u016f mimo l\u00e9k\u00e1rny, kosmetiky, zdravotnick\u00fdch prost\u0159edk\u016f nebo produkt\u016f regenerativn\u00ed medic\u00edny, se pova\u017euje za poru\u0161en\u00ed p\u0159edchoz\u00edho odstavce.<br>3 Nikdo nesm\u00ed nazna\u010dovat potrat nebo pou\u017e\u00edvat obsc\u00e9nn\u00ed dokumenty nebo obr\u00e1zky v souvislosti s l\u00e9ky, l\u00e9ky mimo l\u00e9k\u00e1rny, kosmetikou, zdravotnick\u00fdmi prost\u0159edky nebo produkty regenerativn\u00ed medic\u00edny.<\/p>\n<\/blockquote>\n\n\n\n<p>Z\u00e1kaz p\u0159ehnan\u00e9 reklamy na zdravotnick\u00e9 prost\u0159edky lze shrnout n\u00e1sledovn\u011b:<\/p>\n\n\n\n<ul>\n<li>Z\u00e1kaz inzerov\u00e1n\u00ed, popisov\u00e1n\u00ed nebo \u0161\u00ed\u0159en\u00ed l\u017eiv\u00fdch nebo p\u0159ehnan\u00fdch informac\u00ed o n\u00e1zvu, v\u00fdrobn\u00edm postupu, \u00fa\u010dinnosti, \u00fa\u010dinc\u00edch nebo vlastnostech zdravotnick\u00fdch prost\u0159edk\u016f<\/li>\n\n\n\n<li>Z\u00e1kaz inzerov\u00e1n\u00ed, popisov\u00e1n\u00ed nebo \u0161\u00ed\u0159en\u00ed informac\u00ed, kter\u00e9 by mohly v\u00e9st k nedorozum\u011bn\u00ed, \u017ee l\u00e9ka\u0159 nebo jin\u00e1 osoba zaru\u010duje \u00fa\u010dinnost, \u00fa\u010dinky nebo vlastnosti zdravotnick\u00fdch prost\u0159edk\u016f<\/li>\n\n\n\n<li>Z\u00e1kaz nazna\u010dov\u00e1n\u00ed potratu nebo pou\u017e\u00edv\u00e1n\u00ed obsc\u00e9nn\u00edch dokument\u016f nebo obr\u00e1zk\u016f v souvislosti se zdravotnick\u00fdmi prost\u0159edky<\/li>\n<\/ul>\n\n\n\n<p>Typick\u00fdm p\u0159\u00edkladem p\u0159ehnan\u00e9 reklamy na zdravotnick\u00e9 prost\u0159edky je p\u0159\u00edpad, kdy se inzeruje velk\u00fd \u00fa\u010dinek zdravotnick\u00e9ho prost\u0159edku, kter\u00fd je ve skute\u010dnosti ne\u00fa\u010dinn\u00fd nebo m\u00e1 jen minim\u00e1ln\u00ed \u00fa\u010dinek. Dal\u0161\u00edm p\u0159\u00edkladem m\u016f\u017ee b\u00fdt p\u0159\u00edpad, kdy se inzeruje, \u017ee existuj\u00ed d\u016fkazy o \u00fa\u010dinnosti zdravotnick\u00e9ho prost\u0159edku na z\u00e1klad\u011b konkr\u00e9tn\u00edch dat, i kdy\u017e tato data jsou ve skute\u010dnosti fal\u0161ovan\u00e1.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Zakaz_reklamy_na_zdravotnicke_prostredky_pred_jejich_schvalenim_clanek_68\"><\/span>Z\u00e1kaz reklamy na zdravotnick\u00e9 prost\u0159edky p\u0159ed jejich schv\u00e1len\u00edm (\u010dl\u00e1nek 68)<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p>\u010cl\u00e1nek 68 Japonsk\u00e9ho z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch stanovuje z\u00e1kaz reklamy na zdravotnick\u00e9 prost\u0159edky p\u0159ed jejich schv\u00e1len\u00edm n\u00e1sledovn\u011b:<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>(Z\u00e1kaz reklamy na l\u00e9ky, zdravotnick\u00e9 prost\u0159edky a produkty regenerativn\u00ed medic\u00edny p\u0159ed jejich schv\u00e1len\u00edm)<br>\u010cl\u00e1nek 68 Nikdo nesm\u00ed inzerovat n\u00e1zev, v\u00fdrobn\u00ed postup, \u00fa\u010dinnost, \u00fa\u010dinky nebo vlastnosti l\u00e9k\u016f, zdravotnick\u00fdch prost\u0159edk\u016f nebo produkt\u016f regenerativn\u00ed medic\u00edny, kter\u00e9 jsou uvedeny v \u010dl\u00e1nku 14 odstavec 1, \u010dl\u00e1nku 23-2-5 odstavec 1 nebo \u010dl\u00e1nku 23-2-23 odstavec 1, pokud je\u0161t\u011b neobdr\u017eely schv\u00e1len\u00ed nebo certifikaci podle \u010dl\u00e1nku 14 odstavec 1, \u010dl\u00e1nku 19-2 odstavec 1, \u010dl\u00e1nku 23-2-5 odstavec 1, \u010dl\u00e1nku 23-2-17 odstavec 1, \u010dl\u00e1nku 23-2-25 odstavec 1 nebo \u010dl\u00e1nku 23-2-37 odstavec 1, nebo certifikaci podle \u010dl\u00e1nku 23-2-23 odstavec 1.<\/p>\n<\/blockquote>\n\n\n\n<p>Z\u00e1kaz reklamy na zdravotnick\u00e9 prost\u0159edky p\u0159ed jejich schv\u00e1len\u00edm se t\u00fdk\u00e1 reklamy na n\u00e1zev, v\u00fdrobn\u00ed postup, \u00fa\u010dinnost, \u00fa\u010dinky nebo vlastnosti zdravotnick\u00fdch prost\u0159edk\u016f p\u0159ed jejich schv\u00e1len\u00edm (nebo certifikac\u00ed).<\/p>\n\n\n\n<p>Je t\u0159eba poznamenat, \u017ee i kdy\u017e je zdravotnick\u00fd prost\u0159edek ji\u017e schv\u00e1len v zahrani\u010d\u00ed, pokud je\u0161t\u011b nebyl schv\u00e1len v Japonsku, jeho reklama by poru\u0161ovala z\u00e1kaz reklamy na zdravotnick\u00e9 prost\u0159edky p\u0159ed jejich schv\u00e1len\u00edm.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Shrnuti\"><\/span>Shrnut\u00ed<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full\"><img decoding=\"async\" src=\"https:\/\/monolith.law\/wp-content\/uploads\/2022\/05\/medical-equipment-regulation3.jpg\" alt=\"\" class=\"wp-image-45030\" \/><\/figure><\/div>\n\n\n<p>V\u00fd\u0161e jsme p\u0159edstavili pr\u00e1vn\u00ed regulaci t\u00fdkaj\u00edc\u00ed se reklamy na zdravotnick\u00e9 prost\u0159edky, ur\u010denou pro podnikatele, kte\u0159\u00ed uva\u017euj\u00ed o um\u00edst\u011bn\u00ed takov\u00e9 reklamy.<\/p>\n\n\n\n<p>Je d\u016fle\u017eit\u00e9 si uv\u011bdomit, \u017ee pokud um\u00edst\u00edte reklamu na zdravotnick\u00fd prost\u0159edek bez d\u016fkladn\u00e9ho zkoum\u00e1n\u00ed jej\u00edho obsahu, m\u016f\u017eete poru\u0161it Japonsk\u00fd z\u00e1kon o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch.<\/p>\n\n\n\n<p>Proto je pro podnikatele, kte\u0159\u00ed uva\u017euj\u00ed o reklam\u011b na zdravotnick\u00e9 prost\u0159edky, nezbytn\u00e1 opatrnost.<\/p>\n\n\n\n<p>Zda reklama na zdravotnick\u00fd prost\u0159edek poru\u0161uje regulaci, se rozhoduje na z\u00e1klad\u011b skute\u010dn\u00e9ho \u00fa\u010dinku zdravotnick\u00e9ho prost\u0159edku a vztahu k obsahu reklamy, kterou pl\u00e1nujete um\u00edstit.<\/p>\n\n\n\n<p>Pro posouzen\u00ed, zda reklama na zdravotnick\u00fd prost\u0159edek poru\u0161uje Japonsk\u00fd z\u00e1kon o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch, je nutn\u00e9 prov\u00e9st odborn\u00e9 hodnocen\u00ed.<\/p>\n\n\n\n<p>Proto doporu\u010dujeme podnikatel\u016fm, kte\u0159\u00ed uva\u017euj\u00ed o um\u00edst\u011bn\u00ed reklamy na zdravotnick\u00e9 prost\u0159edky, konzultovat se s pr\u00e1vn\u00edkem s odborn\u00fdmi znalostmi v t\u00e9to oblasti.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Uvod_do_opatreni_nasi_kancelare\"><\/span>\u00davod do opat\u0159en\u00ed na\u0161\u00ed kancel\u00e1\u0159e<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Pr\u00e1vnick\u00e1 kancel\u00e1\u0159 Monolis je pr\u00e1vnick\u00e1 kancel\u00e1\u0159 s vysokou odbornost\u00ed v oblasti IT, zejm\u00e9na internetu a pr\u00e1va. V posledn\u00edch letech se poru\u0161en\u00ed Japonsk\u00e9ho z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch (Yakkihou) stalo velk\u00fdm probl\u00e9mem v oblasti internetov\u00e9 reklamy a pot\u0159eba pr\u00e1vn\u00ed kontroly se st\u00e1le zvy\u0161uje. Na\u0161e kancel\u00e1\u0159 analyzuje pr\u00e1vn\u00ed rizika souvisej\u00edc\u00ed s podnik\u00e1n\u00edm, kter\u00e9 bylo zah\u00e1jeno nebo se pl\u00e1nuje zah\u00e1jit, s ohledem na r\u016fzn\u00e9 pr\u00e1vn\u00ed p\u0159edpisy, a sna\u017e\u00ed se legalizovat podnik\u00e1n\u00ed bez jeho zastaven\u00ed, pokud je to mo\u017en\u00e9. Podrobnosti jsou uvedeny v n\u00e1sleduj\u00edc\u00edm \u010dl\u00e1nku.<\/p>\n\n\n\n<p><a href=\"https:\/\/monolith.law\/operationofmedia\" target=\"_blank\" rel=\"noreferrer noopener\">https:\/\/monolith.law\/operationofmedia[ja]<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Existuje mnoho druh\u016f zdravotnick\u00fdch prost\u0159edk\u016f. N\u011bkter\u00e9 z nich mohou m\u00edt velk\u00fd vliv na na\u0161e t\u011blo a zdrav\u00ed. Pokud dojde k nevhodn\u00e9mu um\u00edst\u011bn\u00ed reklamy na takov\u00e9 zdravotnick\u00e9 prost\u0159edky, existuje riziko, [&hellip;]<\/p>\n","protected":false},"author":32,"featured_media":64083,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[18],"tags":[30,24],"acf":[],"_links":{"self":[{"href":"https:\/\/monolith.law\/cs\/wp-json\/wp\/v2\/posts\/61603"}],"collection":[{"href":"https:\/\/monolith.law\/cs\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/monolith.law\/cs\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/monolith.law\/cs\/wp-json\/wp\/v2\/users\/32"}],"replies":[{"embeddable":true,"href":"https:\/\/monolith.law\/cs\/wp-json\/wp\/v2\/comments?post=61603"}],"version-history":[{"count":2,"href":"https:\/\/monolith.law\/cs\/wp-json\/wp\/v2\/posts\/61603\/revisions"}],"predecessor-version":[{"id":64084,"href":"https:\/\/monolith.law\/cs\/wp-json\/wp\/v2\/posts\/61603\/revisions\/64084"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/monolith.law\/cs\/wp-json\/wp\/v2\/media\/64083"}],"wp:attachment":[{"href":"https:\/\/monolith.law\/cs\/wp-json\/wp\/v2\/media?parent=61603"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/monolith.law\/cs\/wp-json\/wp\/v2\/categories?post=61603"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/monolith.law\/cs\/wp-json\/wp\/v2\/tags?post=61603"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}