{"id":60919,"date":"2023-12-08T20:22:24","date_gmt":"2023-12-08T11:22:24","guid":{"rendered":"https:\/\/monolith.law\/cs\/?p=60919"},"modified":"2024-01-29T17:37:52","modified_gmt":"2024-01-29T08:37:52","slug":"medical-supplies-law","status":"publish","type":"post","link":"https:\/\/monolith.law\/cs\/general-corporate\/medical-supplies-law","title":{"rendered":"Pr\u00e1vn\u00ed regulace reklamy na l\u00e9ky: Vysv\u011btlen\u00ed Japonsk\u00e9ho z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch p\u0159\u00edstroj\u00edch"},"content":{"rendered":"\n<p>Dne 12. \u010dervna 2014 (v gregori\u00e1nsk\u00e9m kalend\u00e1\u0159i) byla \u010d\u00e1st Japonsk\u00e9ho z\u00e1kona o l\u00e9\u010divech (nyn\u00ed Z\u00e1kon 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;) zm\u011bn\u011bna, co\u017e umo\u017enilo prodej l\u00e9\u010div na internetu s v\u00fdjimkou n\u011bkter\u00fdch l\u00e9\u010div.<\/p>\n\n\n\n<p>V d\u016fsledku toho se zv\u00fd\u0161il po\u010det p\u0159\u00edle\u017eitost\u00ed vid\u011bt reklamy na l\u00e9\u010diva na internetu, ale mezi reklamami na l\u00e9\u010diva nejsou nez\u0159\u00eddka tak\u00e9 ty, kter\u00e9 maj\u00ed pr\u00e1vn\u00ed probl\u00e9my.<\/p>\n\n\n\n<p>V tomto \u010dl\u00e1nku proto p\u0159edstav\u00edme pr\u00e1vn\u00ed p\u0159edpisy t\u00fdkaj\u00edc\u00ed se reklamy na l\u00e9\u010diva pro podnikatele, kte\u0159\u00ed uva\u017euj\u00ed o um\u00edst\u011bn\u00ed reklamy na l\u00e9\u010diva.<\/p>\n\n\n\n<p><a href=\"https:\/\/monolith.law\/corporate\/quasi-drug-advertisement-guidelines\" target=\"_blank\" rel=\"noreferrer noopener\">https:\/\/monolith.law\/corporate\/quasi-drug-advertisement-guidelines[ja]<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/monolith.law\/corporate\/supplement-advertisement\" target=\"_blank\" rel=\"noreferrer noopener\">https:\/\/monolith.law\/corporate\/supplement-advertisement[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-supplies-law\/#Regulace_reklamy_podle_Japonskeho_zakona_o_lecivech_a_zdravotnickych_prostredcich\" title=\"Regulace reklamy podle Japonsk\u00e9ho z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch\">Regulace reklamy podle Japonsk\u00e9ho z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch<\/a><ul class='ez-toc-list-level-3'><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/monolith.law\/cs\/general-corporate\/medical-supplies-law\/#Pravni_definice_leku\" title=\"Pr\u00e1vn\u00ed definice l\u00e9k\u016f\">Pr\u00e1vn\u00ed definice l\u00e9k\u016f<\/a><\/li><\/ul><\/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-supplies-law\/#Regulace_reklamnich_projevu_leciv\" title=\"Regulace reklamn\u00edch projev\u016f l\u00e9\u010div\">Regulace reklamn\u00edch projev\u016f l\u00e9\u010div<\/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-supplies-law\/#Definice_%E2%80%9Creklamy%E2%80%9D\" title=\"Definice &#8220;reklamy&#8221;\">Definice &#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-supplies-law\/#Subjekty_regulovane_%E2%80%9Creklamou%E2%80%9D\" title=\"Subjekty regulovan\u00e9 &#8220;reklamou&#8221;\">Subjekty regulovan\u00e9 &#8220;reklamou&#8221;<\/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-supplies-law\/#Jake_projevy_jsou_predmetem_regulace\" title=\"Jak\u00e9 projevy jsou p\u0159edm\u011btem regulace?\">Jak\u00e9 projevy 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-supplies-law\/#Zakaz_prehnane_reklamy_atd_clanek_66\" title=\"Z\u00e1kaz p\u0159ehnan\u00e9 reklamy atd. (\u010dl\u00e1nek 66)\">Z\u00e1kaz p\u0159ehnan\u00e9 reklamy atd. (\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-supplies-law\/#Omezeni_reklamy_na_leciva_urcena_pro_specificke_nemoci_a_vyrobky_regenerativni_mediciny_clanek_67\" title=\"Omezen\u00ed reklamy na l\u00e9\u010diva ur\u010den\u00e1 pro specifick\u00e9 nemoci a v\u00fdrobky regenerativn\u00ed medic\u00edny (\u010dl\u00e1nek 67)\">Omezen\u00ed reklamy na l\u00e9\u010diva ur\u010den\u00e1 pro specifick\u00e9 nemoci a v\u00fdrobky regenerativn\u00ed medic\u00edny (\u010dl\u00e1nek 67)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/monolith.law\/cs\/general-corporate\/medical-supplies-law\/#Zakaz_reklamy_na_leciva_zdravotnicke_prostredky_a_vyrobky_regenerativni_mediciny_pred_jejich_schvalenim_clanek_68\" title=\"Z\u00e1kaz reklamy na l\u00e9\u010diva, zdravotnick\u00e9 prost\u0159edky a v\u00fdrobky regenerativn\u00ed medic\u00edny p\u0159ed jejich schv\u00e1len\u00edm (\u010dl\u00e1nek 68)\">Z\u00e1kaz reklamy na l\u00e9\u010diva, zdravotnick\u00e9 prost\u0159edky a v\u00fdrobky regenerativn\u00ed medic\u00edny 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-10\" href=\"https:\/\/monolith.law\/cs\/general-corporate\/medical-supplies-law\/#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-11\" href=\"https:\/\/monolith.law\/cs\/general-corporate\/medical-supplies-law\/#Predstaveni_opatreni_nasi_kancelare\" title=\"P\u0159edstaven\u00ed opat\u0159en\u00ed na\u0161\u00ed kancel\u00e1\u0159e\">P\u0159edstaven\u00ed 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_podle_Japonskeho_zakona_o_lecivech_a_zdravotnickych_prostredcich\"><\/span>Regulace reklamy podle Japonsk\u00e9ho z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<figure class=\"wp-block-image size-full\"><img decoding=\"async\" src=\"https:\/\/monolith.law\/wp-content\/uploads\/2022\/04\/medical-supplies-law4.jpg\" alt=\"\" class=\"wp-image-44115\" \/><\/figure>\n\n\n\n<p>Japonsk\u00fd z\u00e1kon o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch (Pharmaceuticals and Medical Devices Act) zaji\u0161\u0165uje kvalitu, \u00fa\u010dinnost a bezpe\u010dnost l\u00e9k\u016f a podobn\u00fdch produkt\u016f, a tak\u00e9 prevenci \u0161kod zp\u016fsoben\u00fdch jejich pou\u017eit\u00edm. Z\u00e1kon stanovuje n\u00e1sleduj\u00edc\u00ed regulace:<\/p>\n\n\n\n<ul>\n<li>Z\u00e1kaz p\u0159ehnan\u00e9 reklamy (\u010dl\u00e1nek 66)<\/li>\n\n\n\n<li>Omezen\u00ed reklamy na l\u00e9ky a produkty regenerativn\u00ed medic\u00edny ur\u010den\u00e9 pro specifick\u00e9 nemoci (\u010dl\u00e1nek 67)<\/li>\n\n\n\n<li>Z\u00e1kaz reklamy na l\u00e9ky, zdravotnick\u00e9 prost\u0159edky a produkty regenerativn\u00ed medic\u00edny p\u0159ed jejich schv\u00e1len\u00edm (\u010dl\u00e1nek 68)<\/li>\n<\/ul>\n\n\n\n<p>Pokud dojde k poru\u0161en\u00ed v\u00fd\u0161e uveden\u00fdch ustanoven\u00ed, m\u016f\u017ee b\u00fdt od ministra zdravotnictv\u00ed a soci\u00e1ln\u00edch v\u011bc\u00ed nebo od guvern\u00e9ra prefektury vy\u017eadov\u00e1no zastaven\u00ed poru\u0161ov\u00e1n\u00ed, p\u0159ijet\u00ed nezbytn\u00fdch opat\u0159en\u00ed k zabr\u00e1n\u011bn\u00ed opakov\u00e1n\u00ed poru\u0161en\u00ed, nebo jin\u00fdch opat\u0159en\u00ed k zabr\u00e1n\u011bn\u00ed vzniku ve\u0159ejn\u00e9ho zdravotn\u00edho rizika.<\/p>\n\n\n\n<p>Pokud se v reklam\u011b na l\u00e9ky uv\u00e1d\u011bj\u00ed nepravdiv\u00e9 nebo p\u0159ehnan\u00e9 informace, m\u016f\u017ee b\u00fdt od ministra zdravotnictv\u00ed a soci\u00e1ln\u00edch v\u011bc\u00ed vy\u017eadov\u00e1na platba pokuty.<\/p>\n\n\n\n<p>N\u00ed\u017ee podrobn\u011bji vysv\u011btl\u00edme regulaci reklamy podle Japonsk\u00e9ho z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Pravni_definice_leku\"><\/span>Pr\u00e1vn\u00ed definice l\u00e9k\u016f<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Ne v\u0161echny l\u00e9ky jsou pova\u017eov\u00e1ny za &#8220;l\u00e9ky&#8221; podle Japonsk\u00e9ho z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch. L\u00e9k je pova\u017eov\u00e1n za &#8220;l\u00e9k&#8221; podle tohoto z\u00e1kona, pokud spl\u0148uje definici stanovenou v z\u00e1kon\u011b.<\/p>\n\n\n\n<p>Definice &#8220;l\u00e9ku&#8221; je stanovena v \u010dl\u00e1nku 2 odstavec 1 Japonsk\u00e9ho z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>(Definice)<br>\u010cl\u00e1nek 2 Tento z\u00e1kon definuje &#8220;l\u00e9k&#8221; jako n\u00e1sleduj\u00edc\u00ed:<br>1. Produkty uveden\u00e9 v Japonsk\u00e9 farmakopeji<br>2. Produkty ur\u010den\u00e9 k diagnostice, l\u00e9\u010den\u00ed nebo prevenci nemoc\u00ed u lid\u00ed nebo zv\u00ed\u0159at, kter\u00e9 nejsou stroje nebo n\u00e1stroje (stroje, n\u00e1stroje, dent\u00e1ln\u00ed materi\u00e1ly, zdravotnick\u00e9 pot\u0159eby, hygienick\u00e9 pot\u0159eby a programy (instrukce pro elektronick\u00e9 po\u010d\u00edta\u010de, kter\u00e9 jsou kombinov\u00e1ny tak, aby bylo mo\u017en\u00e9 dos\u00e1hnout ur\u010dit\u00e9ho v\u00fdsledku. Stejn\u011b tak d\u00e1le.) a m\u00e9dia zaznamen\u00e1vaj\u00edc\u00ed tyto programy. Stejn\u011b tak d\u00e1le.) (s v\u00fdjimkou l\u00e9k\u016f pro extern\u00ed pou\u017eit\u00ed a produkt\u016f regenerativn\u00ed medic\u00edny)<br>3. Produkty ur\u010den\u00e9 k ovlivn\u011bn\u00ed struktury nebo funkce t\u011bla lid\u00ed nebo zv\u00ed\u0159at, kter\u00e9 nejsou stroje nebo n\u00e1stroje (s v\u00fdjimkou l\u00e9k\u016f pro extern\u00ed pou\u017eit\u00ed, kosmetiky a produkt\u016f regenerativn\u00ed medic\u00edny)<\/p>\n<\/blockquote>\n\n\n\n<p>Mnoho lid\u00ed mo\u017en\u00e1 nikdy nesly\u0161elo o Japonsk\u00e9 farmakopeji.<\/p>\n\n\n\n<p>Japonsk\u00e1 farmakopej je prezentov\u00e1na na webov\u00fdch str\u00e1nk\u00e1ch Ministerstva zdravotnictv\u00ed, pr\u00e1ce a soci\u00e1ln\u00edch v\u011bc\u00ed n\u00e1sledovn\u011b:<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>Japonsk\u00e1 farmakopej je standardn\u00ed kniha l\u00e9k\u016f stanoven\u00e1 ministrem zdravotnictv\u00ed, pr\u00e1ce a soci\u00e1ln\u00edch v\u011bc\u00ed na z\u00e1klad\u011b konzultace s Radou pro l\u00e9ky a potraviny podle \u010dl\u00e1nku 41 z\u00e1kona o zaji\u0161t\u011bn\u00ed kvality, \u00fa\u010dinnosti a bezpe\u010dnosti l\u00e9k\u016f a zdravotnick\u00fdch prost\u0159edk\u016f atd.<\/p>\n<cite><a href=\"https:\/\/www.mhlw.go.jp\/stf\/seisakunitsuite\/bunya\/0000066530.html\" target=\"_blank\" rel=\"noreferrer noopener\">https:\/\/www.mhlw.go.jp\/stf\/seisakunitsuite\/bunya\/0000066530.html[ja]<\/a><\/cite><\/blockquote>\n\n\n\n<p>Produkty uveden\u00e9 v Japonsk\u00e9 farmakopeji jsou pova\u017eov\u00e1ny za &#8220;l\u00e9ky&#8221; podle \u010dl\u00e1nku 2 odstavec 1 bod 1.<\/p>\n\n\n\n<p>D\u00e1le, i kdy\u017e produkt nen\u00ed uveden v Japonsk\u00e9 farmakopeji, pokud je ur\u010den k diagnostice, l\u00e9\u010den\u00ed nebo prevenci nemoc\u00ed u lid\u00ed nebo zv\u00ed\u0159at, nebo pokud je ur\u010den k ovlivn\u011bn\u00ed struktury nebo funkce t\u011bla lid\u00ed nebo zv\u00ed\u0159at, a nen\u00ed to stroj nebo n\u00e1stroj, a tak\u00e9 nespad\u00e1 pod l\u00e9ky pro extern\u00ed pou\u017eit\u00ed atd. stanoven\u00e9 v Japonsk\u00e9m z\u00e1kon\u011b o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch, je pova\u017eov\u00e1n za &#8220;l\u00e9k&#8221; podle \u010dl\u00e1nku 2 odstavec 1 bod 2 nebo 3.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Regulace_reklamnich_projevu_leciv\"><\/span>Regulace reklamn\u00edch projev\u016f l\u00e9\u010div<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<figure class=\"wp-block-image size-full\"><img decoding=\"async\" src=\"https:\/\/monolith.law\/wp-content\/uploads\/2022\/04\/medical-supplies-law1.jpg\" alt=\"\" class=\"wp-image-44114\" \/><\/figure>\n\n\n\n<p>Regulace reklamn\u00edch projev\u016f t\u00fdkaj\u00edc\u00edch se l\u00e9\u010div se vztahuje, jak bylo uvedeno v\u00fd\u0161e, na p\u0159ehnanou reklamu, reklamu l\u00e9\u010div ur\u010den\u00fdch pro specifick\u00e9 nemoci a v\u00fdrobky regenerativn\u00ed medic\u00edny, a tak\u00e9 na reklamu l\u00e9\u010div, zdravotnick\u00fdch prost\u0159edk\u016f a v\u00fdrobk\u016f regenerativn\u00ed medic\u00edny p\u0159ed jejich schv\u00e1len\u00edm.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Definice_%E2%80%9Creklamy%E2%80%9D\"><\/span>Definice &#8220;reklamy&#8221;<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Term\u00edn &#8220;reklama&#8221; se objevuje v z\u00e1kon\u011b o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch (japonsk\u00fd z\u00e1kon o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch), ale v tomto z\u00e1kon\u011b neexistuje \u017e\u00e1dn\u00e9 ustanoven\u00ed definuj\u00edc\u00ed &#8220;reklamu&#8221;.<\/p>\n\n\n\n<p>Co se t\u00fd\u010de &#8220;reklamy&#8221; podle z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch, jsou uvedeny n\u00e1sleduj\u00edc\u00ed t\u0159i po\u017eadavky v &#8220;Ozn\u00e1men\u00ed o relevanci reklamy na l\u00e9\u010diva atd. podle z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch&#8221; (Ozn\u00e1men\u00ed \u0159editele odd\u011blen\u00ed dohledu a pokyn\u016f pro bezpe\u010dnost l\u00e9\u010div 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)):<\/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 po n\u00e1kupu)<\/li>\n\n\n\n<li>N\u00e1zev konkr\u00e9tn\u00edho l\u00e9\u010diva atd. je jasn\u011b uveden<\/li>\n\n\n\n<li>Je v takov\u00e9m stavu, \u017ee ho m\u016f\u017ee vn\u00edmat ve\u0159ejnost<\/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<p>Pokud je proveden konkr\u00e9tn\u00ed projev a spl\u0148uje v\u0161echny t\u0159i v\u00fd\u0161e uveden\u00e9 po\u017eadavky, je pova\u017eov\u00e1n za &#8220;reklamu&#8221; podle z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Subjekty_regulovane_%E2%80%9Creklamou%E2%80%9D\"><\/span>Subjekty regulovan\u00e9 &#8220;reklamou&#8221;<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Subjekty regulovan\u00e9 reklamou mohou b\u00fdt podle n\u011bkter\u00fdch n\u00e1zor\u016f pouze podnikatel\u00e9 prod\u00e1vaj\u00edc\u00ed p\u0159\u00edslu\u0161n\u00e1 l\u00e9\u010diva.<\/p>\n\n\n\n<p>Av\u0161ak \u00fa\u010delem z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch je, jak bylo uvedeno v\u00fd\u0161e, zajistit kvalitu, \u00fa\u010dinnost a bezpe\u010dnost l\u00e9\u010div atd. a zabr\u00e1nit vzniku a \u0161\u00ed\u0159en\u00ed zdravotn\u00edch rizik spojen\u00fdch s pou\u017e\u00edv\u00e1n\u00edm l\u00e9\u010div atd.<\/p>\n\n\n\n<p>V souvislosti s t\u011bmito c\u00edli nelze dos\u00e1hnout \u00fa\u010delu, pokud se regulace nevztahuje tak\u00e9 na p\u0159\u00edpady, kdy reklamu prov\u00e1d\u00ed n\u011bkdo jin\u00fd ne\u017e podnikatel prod\u00e1vaj\u00edc\u00ed p\u0159\u00edslu\u0161n\u00e1 l\u00e9\u010diva.<\/p>\n\n\n\n<p>Proto z\u00e1kon o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch neomezuje subjekty regulovan\u00e9 reklamou a pokud obecn\u00e1 osoba nebo podnikatel, kter\u00fd neprod\u00e1v\u00e1 l\u00e9\u010diva, provede reklamu t\u00fdkaj\u00edc\u00ed se l\u00e9\u010div, bude podl\u00e9hat regulaci podle z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Jake_projevy_jsou_predmetem_regulace\"><\/span>Jak\u00e9 projevy jsou p\u0159edm\u011btem regulace?<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Jak bylo uvedeno v\u00fd\u0161e, p\u0159edm\u011btem regulace podle z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch jsou z\u00e1kaz p\u0159ehnan\u00e9 reklamy atd. (\u010dl\u00e1nek 66), omezen\u00ed reklamy na l\u00e9\u010diva ur\u010den\u00e1 pro specifick\u00e9 nemoci a v\u00fdrobky regenerativn\u00ed medic\u00edny (\u010dl\u00e1nek 67) a z\u00e1kaz reklamy na l\u00e9\u010diva, zdravotnick\u00e9 prost\u0159edky a v\u00fdrobky regenerativn\u00ed medic\u00edny p\u0159ed jejich schv\u00e1len\u00edm (\u010dl\u00e1nek 68).<\/p>\n\n\n\n<p>N\u00ed\u017ee vysv\u011btl\u00edme ka\u017edou z t\u011bchto regulac\u00ed.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Zakaz_prehnane_reklamy_atd_clanek_66\"><\/span>Z\u00e1kaz p\u0159ehnan\u00e9 reklamy atd. (\u010dl\u00e1nek 66)<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p>Z\u00e1kaz p\u0159ehnan\u00e9 reklamy atd. je stanoven v \u010dl\u00e1nku 66 z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch 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 fale\u0161n\u00e9 nebo p\u0159ehnan\u00e9 \u010dl\u00e1nky t\u00fdkaj\u00edc\u00ed se n\u00e1zvu, v\u00fdrobn\u00ed metody, \u00fa\u010dinnosti, \u00fa\u010dinku nebo vlastnost\u00ed l\u00e9\u010div, l\u00e9\u010div\u00fdch p\u0159\u00edpravk\u016f mimo l\u00e9k\u00e1rny, kosmetiky, zdravotnick\u00fdch prost\u0159edk\u016f nebo v\u00fdrobk\u016f regenerativn\u00ed medic\u00edny, a\u0165 u\u017e jsou explicitn\u00ed nebo implicitn\u00ed.<br>2 \u010cl\u00e1nky, kter\u00e9 by mohly v\u00e9st k nedorozum\u011bn\u00ed, \u017ee l\u00e9ka\u0159 nebo jin\u00e1 osoba zaru\u010duje \u00fa\u010dinnost, \u00fa\u010dinek nebo vlastnosti l\u00e9\u010div, l\u00e9\u010div\u00fdch p\u0159\u00edpravk\u016f mimo l\u00e9k\u00e1rny, kosmetiky, zdravotnick\u00fdch prost\u0159edk\u016f nebo v\u00fdrobk\u016f regenerativn\u00ed medic\u00edny, jsou pova\u017eov\u00e1ny za p\u0159\u00edslu\u0161n\u00e9 k p\u0159edchoz\u00edmu odstavci, pokud jsou inzerov\u00e1ny, pops\u00e1ny nebo \u0161\u00ed\u0159eny.<br>3 Nikdo nesm\u00ed pou\u017e\u00edvat dokumenty nebo obr\u00e1zky nazna\u010duj\u00edc\u00ed potrat nebo obsc\u00e9nnost v souvislosti s l\u00e9\u010divy, l\u00e9\u010div\u00fdmi p\u0159\u00edpravky mimo l\u00e9k\u00e1rny, kosmetikou, zdravotnick\u00fdmi prost\u0159edky nebo v\u00fdrobky regenerativn\u00ed medic\u00edny.<\/p>\n<\/blockquote>\n\n\n\n<p>Z\u00e1kaz p\u0159ehnan\u00e9 reklamy atd. lze shrnout n\u00e1sledovn\u011b:<\/p>\n\n\n\n<ul>\n<li>Z\u00e1kaz reklamy, popisu a \u0161\u00ed\u0159en\u00ed fale\u0161n\u00fdch nebo p\u0159ehnan\u00fdch \u010dl\u00e1nk\u016f t\u00fdkaj\u00edc\u00edch se n\u00e1zvu, v\u00fdrobn\u00ed metody, \u00fa\u010dinnosti, \u00fa\u010dinku nebo vlastnost\u00ed l\u00e9\u010div atd.<\/li>\n\n\n\n<li>Z\u00e1kaz reklamy, popisu a \u0161\u00ed\u0159en\u00ed \u010dl\u00e1nk\u016f, kter\u00e9 by mohly v\u00e9st k nedorozum\u011bn\u00ed, \u017ee l\u00e9ka\u0159 atd. zaru\u010duje \u00fa\u010dinnost, \u00fa\u010dinek nebo vlastnosti l\u00e9\u010div atd.<\/li>\n\n\n\n<li>Z\u00e1kaz pou\u017eit\u00ed dokument\u016f nebo obr\u00e1zk\u016f nazna\u010duj\u00edc\u00edch potrat nebo obsc\u00e9nnost<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Omezeni_reklamy_na_leciva_urcena_pro_specificke_nemoci_a_vyrobky_regenerativni_mediciny_clanek_67\"><\/span>Omezen\u00ed reklamy na l\u00e9\u010diva ur\u010den\u00e1 pro specifick\u00e9 nemoci a v\u00fdrobky regenerativn\u00ed medic\u00edny (\u010dl\u00e1nek 67)<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p>Omezen\u00ed reklamy na l\u00e9\u010diva ur\u010den\u00e1 pro specifick\u00e9 nemoci a v\u00fdrobky regenerativn\u00ed medic\u00edny je stanoveno v \u010dl\u00e1nku 67 z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch n\u00e1sledovn\u011b:<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>(Omezen\u00ed reklamy na l\u00e9\u010diva ur\u010den\u00e1 pro specifick\u00e9 nemoci a v\u00fdrobky regenerativn\u00ed medic\u00edny)<br>\u010cl\u00e1nek 67 U l\u00e9\u010div nebo v\u00fdrobk\u016f regenerativn\u00ed medic\u00edny, kter\u00e9 jsou ur\u010deny k pou\u017eit\u00ed pro rakovinu nebo jin\u00e9 speci\u00e1ln\u00ed nemoci stanoven\u00e9 vl\u00e1dn\u00edm na\u0159\u00edzen\u00edm a kter\u00e9 by mohly zp\u016fsobit zvl\u00e1\u0161t\u011b velk\u00e9 \u0161kody, pokud by nebyly pou\u017e\u00edv\u00e1ny pod veden\u00edm l\u00e9ka\u0159e nebo zubn\u00edho l\u00e9ka\u0159e, m\u016f\u017ee Ministerstvo zdravotnictv\u00ed, pr\u00e1ce a soci\u00e1ln\u00edch v\u011bc\u00ed ur\u010dit l\u00e9\u010diva nebo v\u00fdrobky regenerativn\u00ed medic\u00edny a omezit metody reklamy zam\u011b\u0159en\u00e9 na ve\u0159ejnost mimo l\u00e9ka\u0159sk\u00e9 odborn\u00edky a jin\u00e9 nezbytn\u00e9 opat\u0159en\u00ed pro zaji\u0161t\u011bn\u00ed spr\u00e1vn\u00e9ho pou\u017eit\u00ed t\u011bchto l\u00e9\u010div nebo v\u00fdrobk\u016f regenerativn\u00ed medic\u00edny.<br>2 Ministr zdravotnictv\u00ed, pr\u00e1ce a soci\u00e1ln\u00edch v\u011bc\u00ed mus\u00ed p\u0159ed po\u017e\u00e1d\u00e1n\u00edm o kabinetn\u00ed rozhodnut\u00ed o vyd\u00e1n\u00ed nebo zru\u0161en\u00ed vl\u00e1dn\u00edho na\u0159\u00edzen\u00ed stanovuj\u00edc\u00edho speci\u00e1ln\u00ed nemoci podle p\u0159edchoz\u00edho odstavce v\u017edy konzultovat n\u00e1zory Rady pro l\u00e9\u010diva a potravinovou hygienu. Toto v\u0161ak neplat\u00ed pro p\u0159\u00edpady, kter\u00e9 Rada pro l\u00e9\u010diva a potravinovou hygienu pova\u017euje za drobn\u00e9.<\/p>\n<\/blockquote>\n\n\n\n<p>Omezen\u00ed reklamy na l\u00e9\u010diva ur\u010den\u00e1 pro specifick\u00e9 nemoci a v\u00fdrobky regenerativn\u00ed medic\u00edny se vztahuje na l\u00e9\u010diva pro rakovinu, sarkom a leukemii, kter\u00e1 vy\u017eaduj\u00ed vysokou odbornost p\u0159i pou\u017eit\u00ed, a omezuje reklamu zam\u011b\u0159enou na ve\u0159ejnost mimo l\u00e9ka\u0159sk\u00e9 odborn\u00edky.<\/p>\n\n\n\n<p>Proto, pokud je c\u00edlem l\u00e9ka\u0159sk\u00fd odborn\u00edk, nebude p\u0159edm\u011btem regulace.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Zakaz_reklamy_na_leciva_zdravotnicke_prostredky_a_vyrobky_regenerativni_mediciny_pred_jejich_schvalenim_clanek_68\"><\/span>Z\u00e1kaz reklamy na l\u00e9\u010diva, zdravotnick\u00e9 prost\u0159edky a v\u00fdrobky regenerativn\u00ed medic\u00edny p\u0159ed jejich schv\u00e1len\u00edm (\u010dl\u00e1nek 68)<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p>Z\u00e1kaz reklamy na l\u00e9\u010diva, zdravotnick\u00e9 prost\u0159edky a v\u00fdrobky regenerativn\u00ed medic\u00edny p\u0159ed jejich schv\u00e1len\u00edm je stanoven v \u010dl\u00e1nku 68 z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch n\u00e1sledovn\u011b:<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>(Z\u00e1kaz reklamy na l\u00e9\u010diva, zdravotnick\u00e9 prost\u0159edky a v\u00fdrobky regenerativn\u00ed medic\u00edny p\u0159ed jejich schv\u00e1len\u00edm)<br>\u010cl\u00e1nek 68 Nikdo nesm\u00ed inzerovat n\u00e1zev, v\u00fdrobn\u00ed metodu, \u00fa\u010dinnost, \u00fa\u010dinek nebo vlastnosti l\u00e9\u010div nebo zdravotnick\u00fdch prost\u0159edk\u016f nebo v\u00fdrobk\u016f regenerativn\u00ed medic\u00edny, kter\u00e9 jsou stanoveny v \u010dl\u00e1nku 14 odstavec 1, \u010dl\u00e1nku 23-2-5 odstavec 1 nebo \u010dl\u00e1nku 23-2-23 odstavec 1 a kter\u00e9 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 l\u00e9\u010diva, zdravotnick\u00e9 prost\u0159edky a v\u00fdrobky regenerativn\u00ed medic\u00edny p\u0159ed jejich schv\u00e1len\u00edm se vztahuje na reklamu t\u00fdkaj\u00edc\u00ed se n\u00e1zvu, v\u00fdrobn\u00ed metody, \u00fa\u010dinnosti, \u00fa\u010dinku nebo vlastnost\u00ed l\u00e9\u010div nebo zdravotnick\u00fdch prost\u0159edk\u016f, kter\u00e9 je\u0161t\u011b neobdr\u017eely schv\u00e1len\u00ed (nebo certifikaci).<\/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\n<figure class=\"wp-block-image size-full\"><img decoding=\"async\" src=\"https:\/\/monolith.law\/wp-content\/uploads\/2022\/04\/medical-supplies-law2.jpg\" alt=\"\" class=\"wp-image-44116\" \/><\/figure>\n\n\n\n<p>V\u00fd\u0161e jsme p\u0159edstavili pr\u00e1vn\u00ed regulaci reklamy na l\u00e9\u010diva pro podnikatele, kte\u0159\u00ed uva\u017euj\u00ed o jej\u00edm um\u00edst\u011bn\u00ed.<\/p>\n\n\n\n<p>Pokud se do reklamy na l\u00e9\u010diva pust\u00edte bez d\u016fkladn\u00e9ho pr\u016fzkumu, m\u016f\u017eete poru\u0161it z\u00e1kon.<\/p>\n\n\n\n<p>Je t\u0159eba b\u00fdt obzvl\u00e1\u0161t\u011b opatrn\u00fd, proto\u017ee se \u010dasto vyskytuj\u00ed p\u0159\u00edpady, kter\u00e9 poru\u0161uj\u00ed z\u00e1kaz p\u0159ehnan\u00e9 reklamy a podobn\u011b. Pokud jste podnikatel, kter\u00fd uva\u017euje o reklam\u011b na l\u00e9\u010diva, je t\u0159eba b\u00fdt opatrn\u00fd.<\/p>\n\n\n\n<p>Ur\u010den\u00ed, zda reklama na l\u00e9\u010diva poru\u0161uje regulaci reklamy, vy\u017eaduje konkr\u00e9tn\u00ed posouzen\u00ed v souvislosti s obsahem reklamy, kterou pl\u00e1nujete um\u00edstit. Pokud jste podnikatel, kter\u00fd uva\u017euje o um\u00edst\u011bn\u00ed reklamy na l\u00e9\u010diva, doporu\u010dujeme se poradit s pr\u00e1vn\u00edkem, kter\u00fd m\u00e1 odborn\u00e9 znalosti.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Predstaveni_opatreni_nasi_kancelare\"><\/span>P\u0159edstaven\u00ed opat\u0159en\u00ed na\u0161\u00ed kancel\u00e1\u0159e<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Pr\u00e1vn\u00ed kancel\u00e1\u0159 Monolis je pr\u00e1vn\u00ed 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 ozna\u010dov\u00e1n\u00ed zbo\u017e\u00ed, jako je klamav\u00e1 reklama na internetu, st\u00e1v\u00e1 velk\u00fdm probl\u00e9mem 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 co nejv\u00edce bez jeho zastaven\u00ed. Podrobnosti jsou uvedeny v n\u00e1sleduj\u00edc\u00edm \u010dl\u00e1nku.<\/p>\n\n\n<figure class=\"is-type-wp-embed\">\n<div>practices\/corporate<\/div>\n<\/figure>","protected":false},"excerpt":{"rendered":"<p>Dne 12. \u010dervna 2014 (v gregori\u00e1nsk\u00e9m kalend\u00e1\u0159i) byla \u010d\u00e1st Japonsk\u00e9ho z\u00e1kona o l\u00e9\u010divech (nyn\u00ed Z\u00e1kon 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 [&hellip;]<\/p>\n","protected":false},"author":32,"featured_media":62445,"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\/60919"}],"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=60919"}],"version-history":[{"count":3,"href":"https:\/\/monolith.law\/cs\/wp-json\/wp\/v2\/posts\/60919\/revisions"}],"predecessor-version":[{"id":62526,"href":"https:\/\/monolith.law\/cs\/wp-json\/wp\/v2\/posts\/60919\/revisions\/62526"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/monolith.law\/cs\/wp-json\/wp\/v2\/media\/62445"}],"wp:attachment":[{"href":"https:\/\/monolith.law\/cs\/wp-json\/wp\/v2\/media?parent=60919"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/monolith.law\/cs\/wp-json\/wp\/v2\/categories?post=60919"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/monolith.law\/cs\/wp-json\/wp\/v2\/tags?post=60919"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}