{"id":61592,"date":"2023-12-08T20:25:38","date_gmt":"2023-12-08T11:25:38","guid":{"rendered":"https:\/\/monolith.law\/cs\/?p=61592"},"modified":"2024-03-30T18:18:40","modified_gmt":"2024-03-30T09:18:40","slug":"pharmaceuticals-law-revision","status":"publish","type":"post","link":"https:\/\/monolith.law\/cs\/general-corporate\/pharmaceuticals-law-revision","title":{"rendered":"Obsah zm\u011bny l\u00e9k\u00e1rensk\u00e9ho z\u00e1kona v prvn\u00edm roce Reiwa (2019) ~ Budoucnost l\u00e9k\u00e1ren a l\u00e9k\u00e1rn\u00edk\u016f, syst\u00e9m pokut ~"},"content":{"rendered":"\n<p>Novela z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch, kter\u00e1 byla vyhl\u00e1\u0161ena 4. prosince prvn\u00edho roku \u00e9ry Reiwa (2019), a jej\u00ed\u017e postupn\u00e9 zav\u00e1d\u011bn\u00ed je pl\u00e1nov\u00e1no, je tak rozs\u00e1hl\u00e1, \u017ee je ozna\u010dov\u00e1na jako &#8220;Velk\u00e1 novela \u00e9ry Reiwa&#8221;, a byla provedena v mnoha oblastech.<\/p>\n\n\n\n<p>Tato novela se zam\u011b\u0159uje p\u0159edev\u0161\u00edm na t\u0159i oblasti: \u2460 zlep\u0161en\u00ed syst\u00e9mu od v\u00fdvoje l\u00e9k\u016f a dal\u0161\u00edch produkt\u016f a\u017e po jejich prodej, \u2461 p\u0159ehodnocen\u00ed role l\u00e9k\u00e1rn\u00edk\u016f a l\u00e9k\u00e1ren, a \u2462 vytvo\u0159en\u00ed syst\u00e9mu pro dodr\u017eov\u00e1n\u00ed z\u00e1kon\u016f a na\u0159\u00edzen\u00ed za \u00fa\u010delem zaji\u0161t\u011bn\u00ed d\u016fv\u011bry. Zejm\u00e9na v p\u0159\u00edpad\u011b bodu \u2462 budou v d\u016fsledku nov\u00e9ho syst\u00e9mu nutn\u00e1 opat\u0159en\u00ed ze strany podnik\u016f.<\/p>\n\n\n\n<p>V tomto \u010dl\u00e1nku se zam\u011b\u0159\u00edme na bod \u2461 a na zaveden\u00ed syst\u00e9mu pokut v r\u00e1mci bodu \u2462.<\/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\/pharmaceuticals-law-revision\/#Co_je_to_zakon_o_lecivech_a_zdravotnickych_prostredcich_drive_zakon_o_lecivech\" title=\"Co je to z\u00e1kon o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch (d\u0159\u00edve z\u00e1kon o l\u00e9\u010divech)\">Co je to z\u00e1kon o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch (d\u0159\u00edve z\u00e1kon o l\u00e9\u010divech)<\/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\/pharmaceuticals-law-revision\/#Ucel_zakona_o_lecivech_a_zdravotnickych_prostredcich_Japonsky_zakon_o_lecivech_a_zdravotnickych_prostredcich\" title=\"\u00da\u010del z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch (Japonsk\u00fd z\u00e1kon o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch)\">\u00da\u010del z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch (Japonsk\u00fd z\u00e1kon o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/monolith.law\/cs\/general-corporate\/pharmaceuticals-law-revision\/#Regulace_podle_Japonskeho_zakona_o_lecivech_a_zdravotnickych_prostredcich_Pharmaceuticals_and_Medical_Devices_Act\" title=\"Regulace podle Japonsk\u00e9ho z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch (Pharmaceuticals and Medical Devices Act)\">Regulace podle Japonsk\u00e9ho z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch (Pharmaceuticals and Medical Devices Act)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/monolith.law\/cs\/general-corporate\/pharmaceuticals-law-revision\/#Regulace_tykajici_se_reklamy\" title=\"Regulace t\u00fdkaj\u00edc\u00ed se reklamy\">Regulace t\u00fdkaj\u00edc\u00ed se reklamy<\/a><ul class='ez-toc-list-level-4'><li class='ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/monolith.law\/cs\/general-corporate\/pharmaceuticals-law-revision\/#Zakaz_lzive_a_prehnane_reklamy\" title=\"Z\u00e1kaz l\u017eiv\u00e9 a p\u0159ehnan\u00e9 reklamy\">Z\u00e1kaz l\u017eiv\u00e9 a p\u0159ehnan\u00e9 reklamy<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/monolith.law\/cs\/general-corporate\/pharmaceuticals-law-revision\/#Omezeni_reklamy_na_leky_a_produkty_regenerativni_mediciny_pro_specificke_nemoci\" title=\"Omezen\u00ed reklamy na l\u00e9ky a produkty regenerativn\u00ed medic\u00edny pro specifick\u00e9 nemoci\">Omezen\u00ed reklamy na l\u00e9ky a produkty regenerativn\u00ed medic\u00edny pro specifick\u00e9 nemoci<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/monolith.law\/cs\/general-corporate\/pharmaceuticals-law-revision\/#Zakaz_reklamy_na_nepovolene_leky_a_podobne_produkty\" title=\"Z\u00e1kaz reklamy na nepovolen\u00e9 l\u00e9ky a podobn\u00e9 produkty\">Z\u00e1kaz reklamy na nepovolen\u00e9 l\u00e9ky a podobn\u00e9 produkty<\/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-8\" href=\"https:\/\/monolith.law\/cs\/general-corporate\/pharmaceuticals-law-revision\/#Prehodnoceni_role_lekarniku_a_lekaren\" title=\"P\u0159ehodnocen\u00ed role l\u00e9k\u00e1rn\u00edk\u016f a l\u00e9k\u00e1ren\">P\u0159ehodnocen\u00ed role l\u00e9k\u00e1rn\u00edk\u016f a l\u00e9k\u00e1ren<\/a><ul class='ez-toc-list-level-3'><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/monolith.law\/cs\/general-corporate\/pharmaceuticals-law-revision\/#Zjasneni_role_lekarniku_a_lekaren\" title=\"Zjasn\u011bn\u00ed role l\u00e9k\u00e1rn\u00edk\u016f a l\u00e9k\u00e1ren\">Zjasn\u011bn\u00ed role l\u00e9k\u00e1rn\u00edk\u016f a l\u00e9k\u00e1ren<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/monolith.law\/cs\/general-corporate\/pharmaceuticals-law-revision\/#System_certifikovanych_lekaren\" title=\"Syst\u00e9m certifikovan\u00fdch l\u00e9k\u00e1ren\">Syst\u00e9m certifikovan\u00fdch l\u00e9k\u00e1ren<\/a><ul class='ez-toc-list-level-4'><li class='ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/monolith.law\/cs\/general-corporate\/pharmaceuticals-law-revision\/#Co_je_to_lekarna_spolupracujici_s_komunitou\" title=\"Co je to l\u00e9k\u00e1rna spolupracuj\u00edc\u00ed s komunitou?\">Co je to l\u00e9k\u00e1rna spolupracuj\u00edc\u00ed s komunitou?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-12\" href=\"https:\/\/monolith.law\/cs\/general-corporate\/pharmaceuticals-law-revision\/#Co_je_to_lekarna_spolupracujici_se_specializovanymi_zdravotnickymi_zarizenimi\" title=\"Co je to l\u00e9k\u00e1rna spolupracuj\u00edc\u00ed se specializovan\u00fdmi zdravotnick\u00fdmi za\u0159\u00edzen\u00edmi?\">Co je to l\u00e9k\u00e1rna spolupracuj\u00edc\u00ed se specializovan\u00fdmi zdravotnick\u00fdmi za\u0159\u00edzen\u00edmi?<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-13\" href=\"https:\/\/monolith.law\/cs\/general-corporate\/pharmaceuticals-law-revision\/#Online_pokyny_pro_uzivani_leku\" title=\"Online pokyny pro u\u017e\u00edv\u00e1n\u00ed l\u00e9k\u016f\">Online pokyny pro u\u017e\u00edv\u00e1n\u00ed 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-14\" href=\"https:\/\/monolith.law\/cs\/general-corporate\/pharmaceuticals-law-revision\/#Co_je_to_system_pokut_pridany_v_ramci_novely_Japonskeho_zakona_o_lecivech_a_zdravotnickych_prostredcich\" title=\"Co je to syst\u00e9m pokut p\u0159idan\u00fd v r\u00e1mci novely Japonsk\u00e9ho z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch\">Co je to syst\u00e9m pokut p\u0159idan\u00fd v r\u00e1mci novely 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-15\" href=\"https:\/\/monolith.law\/cs\/general-corporate\/pharmaceuticals-law-revision\/#Pokuta_cini_45_z_obratu\" title=\"Pokuta \u010din\u00ed 4,5% z obratu\">Pokuta \u010din\u00ed 4,5% z obratu<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-16\" href=\"https:\/\/monolith.law\/cs\/general-corporate\/pharmaceuticals-law-revision\/#Regulovane_subjekty\" title=\"Regulovan\u00e9 subjekty\">Regulovan\u00e9 subjekty<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-17\" href=\"https:\/\/monolith.law\/cs\/general-corporate\/pharmaceuticals-law-revision\/#Dodatecne_prikazy_v_ramci_zmeny_zakona_o_lecivech_a_zdravotnickych_prostredcich\" title=\"Dodate\u010dn\u00e9 p\u0159\u00edkazy v r\u00e1mci zm\u011bny z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch\">Dodate\u010dn\u00e9 p\u0159\u00edkazy v r\u00e1mci zm\u011bny z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-18\" href=\"https:\/\/monolith.law\/cs\/general-corporate\/pharmaceuticals-law-revision\/#Opatreni_ktera_by_mely_podniky_prijmout_v_dusledku_zmeny_Japonskeho_zakona_o_lecivech_a_zdravotnickych_prostredcich\" title=\"Opat\u0159en\u00ed, kter\u00e1 by m\u011bly podniky p\u0159ijmout v d\u016fsledku zm\u011bny Japonsk\u00e9ho z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch\">Opat\u0159en\u00ed, kter\u00e1 by m\u011bly podniky p\u0159ijmout v d\u016fsledku zm\u011bny 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-19\" href=\"https:\/\/monolith.law\/cs\/general-corporate\/pharmaceuticals-law-revision\/#Znovu_zkontrolujte_reklamu_na_vlastni_vyrobky\" title=\"Znovu zkontrolujte reklamu na vlastn\u00ed v\u00fdrobky\">Znovu zkontrolujte reklamu na vlastn\u00ed v\u00fdrobky<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-20\" href=\"https:\/\/monolith.law\/cs\/general-corporate\/pharmaceuticals-law-revision\/#Vytvorte_vlastni_smernice_a_informujte_o_nich\" title=\"Vytvo\u0159te vlastn\u00ed sm\u011brnice a informujte o nich\">Vytvo\u0159te vlastn\u00ed sm\u011brnice a informujte o nich<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-21\" href=\"https:\/\/monolith.law\/cs\/general-corporate\/pharmaceuticals-law-revision\/#Shrnuti_Nejasnosti_vyplyvajici_ze_zmeny_Japonskeho_zakona_o_lecivech_a_zdravotnickych_prostredcich_by_mely_byt_konzultovany_s_pravnikem\" title=\"Shrnut\u00ed: Nejasnosti vypl\u00fdvaj\u00edc\u00ed ze zm\u011bny Japonsk\u00e9ho z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch by m\u011bly b\u00fdt konzultov\u00e1ny s pr\u00e1vn\u00edkem\">Shrnut\u00ed: Nejasnosti vypl\u00fdvaj\u00edc\u00ed ze zm\u011bny Japonsk\u00e9ho z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch by m\u011bly b\u00fdt konzultov\u00e1ny s pr\u00e1vn\u00edkem<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-22\" href=\"https:\/\/monolith.law\/cs\/general-corporate\/pharmaceuticals-law-revision\/#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=\"Co_je_to_zakon_o_lecivech_a_zdravotnickych_prostredcich_drive_zakon_o_lecivech\"><\/span>Co je to z\u00e1kon o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch (d\u0159\u00edve z\u00e1kon o l\u00e9\u010divech)<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\/08\/shutterstock_1080775979.jpg\" alt=\"Z\u00e1kon o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch (d\u0159\u00edve z\u00e1kon o l\u00e9\u010divech)\" class=\"wp-image-50166\" \/><\/figure>\n\n\n\n<p>Z\u00e1kon o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch je z\u00e1kon, kter\u00fd byl zaveden za \u00fa\u010delem zaji\u0161t\u011bn\u00ed kvality, \u00fa\u010dinnosti a bezpe\u010dnosti l\u00e9\u010div a zdravotnick\u00fdch prost\u0159edk\u016f a zlep\u0161en\u00ed ve\u0159ejn\u00e9ho zdrav\u00ed. Jeho ofici\u00e1ln\u00ed n\u00e1zev je &#8220;Z\u00e1kon o zaji\u0161t\u011bn\u00ed kvality, \u00fa\u010dinnosti a bezpe\u010dnosti l\u00e9\u010div a zdravotnick\u00fdch prost\u0159edk\u016f a podobn\u00fdch v\u00fdrobk\u016f&#8221;.<\/p>\n\n\n\n<p>P\u016fvodn\u011b se naz\u00fdval z\u00e1kon o l\u00e9\u010divech, ale v roce Heisei 26 (2014) byl zm\u011bn\u011bn na sou\u010dasn\u00fd n\u00e1zev, kdy\u017e byl revidov\u00e1n s hlavn\u00edmi c\u00edli \u2460 pos\u00edlen\u00ed bezpe\u010dnostn\u00edch opat\u0159en\u00ed pro l\u00e9\u010diva a zdravotnick\u00e9 prost\u0159edky, \u2461 vytvo\u0159en\u00ed regulace s ohledem na charakteristiky zdravotnick\u00fdch prost\u0159edk\u016f a \u2462 vytvo\u0159en\u00ed regulace s ohledem na charakteristiky produkt\u016f regenerativn\u00ed medic\u00edny.<\/p>\n\n\n\n<p>Pot\u00e9 byl 4. prosince Reiwa 1 (2019) vyhl\u00e1\u0161en z\u00e1kon o zm\u011bn\u011b n\u011bkter\u00fdch \u010d\u00e1st\u00ed z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch, kter\u00fd byl z\u00e1sadn\u011b zaveden 1. z\u00e1\u0159\u00ed Reiwa 2 (2020), p\u0159i\u010dem\u017e v\u00fdjimky byly zavedeny postupn\u011b. Syst\u00e9m pokut, kter\u00fd je p\u0159edstaven v druh\u00e9 polovin\u011b tohoto \u010dl\u00e1nku, byl zaveden 1. srpna Reiwa 3 (2021).<\/p>\n\n\n\n<p>Souvisej\u00edc\u00ed \u010dl\u00e1nek: <a href=\"https:\/\/monolith.law\/?p=49834\" target=\"_blank\" rel=\"noreferrer noopener\">Co je to z\u00e1kon o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch (d\u0159\u00edve z\u00e1kon o l\u00e9\u010divech)? Vysv\u011btlen\u00ed c\u00edl\u016f, regulovan\u00fdch subjekt\u016f a regulace reklamy[ja]<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Ucel_zakona_o_lecivech_a_zdravotnickych_prostredcich_Japonsky_zakon_o_lecivech_a_zdravotnickych_prostredcich\"><\/span>\u00da\u010del z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch (Japonsk\u00fd z\u00e1kon o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch)<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>(\u00da\u010del)<\/p>\n\n\n\n<p>Tento z\u00e1kon m\u00e1 za c\u00edl zaji\u0161\u0165ovat kvalitu, \u00fa\u010dinnost a bezpe\u010dnost l\u00e9k\u016f, l\u00e9\u010div\u00fdch p\u0159\u00edpravk\u016f, kosmetiky, zdravotnick\u00fdch prost\u0159edk\u016f a produkt\u016f regenerativn\u00ed medic\u00edny (d\u00e1le jen &#8220;l\u00e9ky atd.&#8221;) a p\u0159edch\u00e1zet vzniku a \u0161\u00ed\u0159en\u00ed zdravotn\u00edch rizik spojen\u00fdch s jejich pou\u017eit\u00edm prost\u0159ednictv\u00edm nezbytn\u00e9 regulace. Krom\u011b toho, tento z\u00e1kon stanovuje opat\u0159en\u00ed t\u00fdkaj\u00edc\u00ed se regulace ur\u010dit\u00fdch l\u00e9k\u016f a podporuje v\u00fdzkum a v\u00fdvoj l\u00e9k\u016f atd., kter\u00e9 jsou zvl\u00e1\u0161t\u011b pot\u0159ebn\u00e9 v medic\u00edn\u011b, s c\u00edlem zlep\u0161it ve\u0159ejn\u00e9 zdrav\u00ed.<\/p>\n<cite><a href=\"https:\/\/elaws.e-gov.go.jp\/document?lawid=335AC0000000145\" target=\"_blank\" rel=\"noreferrer noopener\">\u010cl\u00e1nek 1 z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch[ja]<\/a><\/cite><\/blockquote>\n\n\n\n<p>Podle \u010dl\u00e1nku 1 z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch je \u00fa\u010delem tohoto z\u00e1kona:<\/p>\n\n\n\n<ul>\n<li>Regulace nezbytn\u00e9 pro zaji\u0161t\u011bn\u00ed kvality, \u00fa\u010dinnosti a bezpe\u010dnosti l\u00e9k\u016f atd.<\/li>\n\n\n\n<li>Regulace nezbytn\u00e9 pro p\u0159edch\u00e1zen\u00ed vzniku a \u0161\u00ed\u0159en\u00ed zdravotn\u00edch rizik spojen\u00fdch s pou\u017eit\u00edm l\u00e9k\u016f atd.<\/li>\n\n\n\n<li>Opat\u0159en\u00ed t\u00fdkaj\u00edc\u00ed se regulace ur\u010dit\u00fdch l\u00e9k\u016f<\/li>\n\n\n\n<li>Opat\u0159en\u00ed pro podporu v\u00fdzkumu a v\u00fdvoje l\u00e9k\u016f atd.<\/li>\n<\/ul>\n\n\n\n<p>Prost\u0159ednictv\u00edm t\u011bchto opat\u0159en\u00ed se sna\u017e\u00ed zlep\u0161it ve\u0159ejn\u00e9 zdrav\u00ed.<\/p>\n\n\n\n<p>L\u00e9ky atd., a\u010dkoli p\u0159isp\u00edvaj\u00ed k lidsk\u00e9mu zdrav\u00ed, mohou p\u0159i pou\u017eit\u00ed s probl\u00e9my v \u00fa\u010dinnosti a bezpe\u010dnosti po\u0161kodit zdrav\u00ed a ohrozit \u017eivoty.<\/p>\n\n\n\n<p>Proto z\u00e1kon o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch stanovuje p\u0159\u00edsn\u00e9 regulace, jako je regulace p\u0159ehnan\u00e9 reklamy, s c\u00edlem p\u0159edch\u00e1zet vlivu na lidsk\u00e9 t\u011blo a chr\u00e1nit zdrav\u00ed a bezpe\u010dnost ob\u010dan\u016f.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Regulace_podle_Japonskeho_zakona_o_lecivech_a_zdravotnickych_prostredcich_Pharmaceuticals_and_Medical_Devices_Act\"><\/span>Regulace podle Japonsk\u00e9ho z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch (Pharmaceuticals and Medical Devices Act)<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Produkty regulovan\u00e9 Japonsk\u00fdm z\u00e1konem o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch (Pharmaceuticals and Medical Devices Act) lze rozd\u011blit do n\u00e1sleduj\u00edc\u00edch p\u011bti kategori\u00ed:<\/p>\n\n\n\n<ul>\n<li>L\u00e9ky: l\u00e9ky na p\u0159edpis, voln\u011b prodejn\u00e9 l\u00e9ky, vakc\u00edny atd.<\/li>\n\n\n\n<li>Quasi-l\u00e9ky: kloktadla, insekticidy, barvy na vlasy, roztoky pro kontaktn\u00ed \u010do\u010dky atd.<\/li>\n\n\n\n<li>Kosmetika: m\u00fddla, t\u011blov\u00e9 \u0161ampony, v\u00fdrobky pro p\u00e9\u010di o vlasy, v\u00fdrobky pro p\u00e9\u010di o ple\u0165 atd.<\/li>\n\n\n\n<li>Zdravotnick\u00e9 prost\u0159edky: kardiostimul\u00e1tory, um\u011bl\u00e9 klouby, teplom\u011bry, skalpely atd.<\/li>\n\n\n\n<li>Produkty regenerativn\u00ed medic\u00edny: bu\u0148ky upraven\u00e9 pro l\u00e9\u010debn\u00e9 \u00fa\u010dely (nap\u0159. iPS bu\u0148ky), produkty pro genovou terapii<\/li>\n<\/ul>\n\n\n\n<p>Jak jsou tedy regulov\u00e1ny takzvan\u00e9 zdravotn\u00ed potraviny, kter\u00e9 m\u016f\u017eeme vid\u011bt v l\u00e9k\u00e1rn\u00e1ch a podobn\u011b?<\/p>\n\n\n\n<p>Ve vztahu k zdravotn\u00edm potravin\u00e1m neexistuje definice podle Japonsk\u00e9ho z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch. Potraviny a n\u00e1poje jsou klasifikov\u00e1ny jako &#8220;potraviny&#8221; a &#8220;l\u00e9ky&#8221; (podle \u010dl\u00e1nku 4 odstavec 1 Japonsk\u00e9ho z\u00e1kona o potravinov\u00e9 hygien\u011b), tak\u017ee zdravotn\u00ed potraviny jsou klasifikov\u00e1ny jako &#8220;potraviny&#8221;.<\/p>\n\n\n\n<p>Av\u0161ak, jak budeme diskutovat n\u00ed\u017ee, zobrazov\u00e1n\u00ed \u00fa\u010dink\u016f a v\u00fdhod podobn\u00fdch l\u00e9k\u016fm na produktech, kter\u00e9 nejsou &#8220;l\u00e9ky&#8221;, je v rozporu s \u010dl\u00e1nkem 68 Japonsk\u00e9ho z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch. Proto existuje syst\u00e9m zdravotn\u00edch potravin s funkc\u00ed zdrav\u00ed, kter\u00fd umo\u017e\u0148uje zobrazov\u00e1n\u00ed \u00fa\u010dink\u016f a v\u00fdhod na &#8220;potravin\u00e1ch&#8221;.<\/p>\n\n\n\n<p>Zdravotn\u00ed potraviny jsou klasifikov\u00e1ny jako &#8220;potraviny&#8221; a proto nejsou prim\u00e1rn\u011b regulov\u00e1ny Japonsk\u00fdm z\u00e1konem o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch.<\/p>\n\n\n\n<p>Pro v\u00edce informac\u00ed o takzvan\u00fdch zdravotn\u00edch potravin\u00e1ch se pod\u00edvejte na tento \u010dl\u00e1nek.<\/p>\n\n\n\n<p>Souvisej\u00edc\u00ed \u010dl\u00e1nek: <a href=\"https:\/\/monolith.law\/?p=49842\" target=\"_blank\" rel=\"noreferrer noopener\">Co je regulace reklamy podle Japonsk\u00e9ho z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch? Vysv\u011btlen\u00ed kl\u00ed\u010dov\u00fdch bod\u016f pro vytv\u00e1\u0159en\u00ed reklamy v souladu se z\u00e1konem[ja]<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Regulace_tykajici_se_reklamy\"><\/span>Regulace t\u00fdkaj\u00edc\u00ed se reklamy<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<figure class=\"wp-block-image size-full\"><img decoding=\"async\" src=\"https:\/\/monolith.law\/wp-content\/uploads\/2022\/08\/shutterstock_1217867398.png\" alt=\"Regulace t\u00fdkaj\u00edc\u00ed se reklamy\" class=\"wp-image-49984\" \/><\/figure>\n\n\n\n<p>Z\u00e1kon o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch (Japonsk\u00fd z\u00e1kon o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch) p\u0159\u00edsn\u011b reguluje reklamu na l\u00e9ky a podobn\u00e9 produkty. Obsah regulace lze rozd\u011blit do t\u0159\u00ed hlavn\u00edch kategori\u00ed.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Zakaz_lzive_a_prehnane_reklamy\"><\/span>Z\u00e1kaz l\u017eiv\u00e9 a p\u0159ehnan\u00e9 reklamy<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 (Pharmaceuticals and Medical Devices Act) zakazuje l\u017eivou a p\u0159ehnanou reklamu na l\u00e9ky a podobn\u00e9 produkty.<\/p>\n\n\n\n<p>Pokud obsahuje reklama na l\u00e9ky a podobn\u00e9 produkty l\u017eiv\u00e9 nebo p\u0159ehnan\u00e9 tvrzen\u00ed, m\u016f\u017ee to m\u00edt nep\u0159edv\u00eddan\u00fd dopad na zdrav\u00ed u\u017eivatel\u016f, kte\u0159\u00ed t\u011bmto tvrzen\u00edm d\u016fv\u011b\u0159uj\u00ed.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>(P\u0159ehnan\u00e1 reklama atd.)<\/p>\n\n\n\n<p>1 Nikdo nesm\u00ed inzerovat, popisovat nebo \u0161\u00ed\u0159it l\u017eiv\u00e9 nebo p\u0159ehnan\u00e9 \u010dl\u00e1nky 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 explicitn\u00ed nebo implicitn\u00ed.<\/p>\n\n\n\n<p>2 \u010cl\u00e1nky, kter\u00e9 by mohly v\u00e9st k omylu, \u017ee \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 jsou zaru\u010deny l\u00e9ka\u0159em nebo jinou osobou, se pova\u017euj\u00ed za p\u0159\u00edslu\u0161n\u00e9 k p\u0159edchoz\u00edmu odstavci.<\/p>\n\n\n\n<p>3 Nikdo nesm\u00ed pou\u017e\u00edvat dokumenty nebo obr\u00e1zky nazna\u010duj\u00edc\u00ed potrat nebo obsc\u00e9nnost v souvislosti s l\u00e9ky, l\u00e9ky mimo l\u00e9k\u00e1rny, kosmetikou, zdravotnick\u00fdmi prost\u0159edky nebo produkty regenerativn\u00ed medic\u00edny.<\/p>\n<cite><a href=\"https:\/\/elaws.e-gov.go.jp\/document?lawid=335AC0000000145\" target=\"_blank\" rel=\"noreferrer noopener\">\u010cl\u00e1nek 66 Japonsk\u00e9ho z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch[ja]<\/a><\/cite><\/blockquote>\n\n\n\n<p>Zak\u00e1z\u00e1no je nejen uv\u00e1d\u011bn\u00ed \u00fa\u010dink\u016f a v\u00fdsledk\u016f, kter\u00e9 l\u00e9ky a podobn\u00e9 produkty neobsahuj\u00ed, nebo napodobov\u00e1n\u00ed n\u00e1zv\u016f l\u00e9k\u016f dostupn\u00fdch v l\u00e9k\u00e1rn\u00e1ch, ale tak\u00e9 v\u00fdrazy, kter\u00e9 by mohly vyvolat dojem, \u017ee \u00fa\u010dinky a v\u00fdsledky jsou zaru\u010deny l\u00e9ka\u0159em nebo jin\u00fdm odborn\u00edkem, i kdy\u017e jsou spr\u00e1vn\u00e9. Nap\u0159\u00edklad, i kdy\u017e je produkt schv\u00e1len jako l\u00e9k nebo l\u00e9k mimo l\u00e9k\u00e1rnu, nebo je to kosmetika, pokud se jeho \u00fa\u010dinky a v\u00fdsledky prezentuj\u00ed nad r\u00e1mec schv\u00e1len\u00fdch \u00fa\u010dink\u016f a v\u00fdsledk\u016f, nap\u0159\u00edklad tvrzen\u00edm, \u017ee &#8220;odstra\u0148uje skvrny a pihy&#8221;, je to pova\u017eov\u00e1no za l\u017eivou a p\u0159ehnanou reklamu.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Omezeni_reklamy_na_leky_a_produkty_regenerativni_mediciny_pro_specificke_nemoci\"><\/span>Omezen\u00ed reklamy na l\u00e9ky a produkty regenerativn\u00ed medic\u00edny pro specifick\u00e9 nemoci<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p>\u010cl\u00e1nek 67 Japonsk\u00e9ho z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch (Pharmaceuticals and Medical Devices Act) stanovuje, \u017ee pro l\u00e9ky ur\u010den\u00e9 pro specifick\u00e9 nemoci jsou stanovena nezbytn\u00e1 opat\u0159en\u00ed v na\u0159\u00edzen\u00ed Ministerstva zdravotnictv\u00ed, pr\u00e1ce a soci\u00e1ln\u00edch v\u011bc\u00ed.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>(Omezen\u00ed reklamy na l\u00e9ky a produkty regenerativn\u00ed medic\u00edny pro specifick\u00e9 nemoci)<\/p>\n\n\n\n<p>1 Pro l\u00e9ky nebo produkty regenerativn\u00ed medic\u00edny, kter\u00e9 jsou ur\u010deny k pou\u017eit\u00ed pro rakovinu nebo jin\u00e9 specifick\u00e9 nemoci stanoven\u00e9 vl\u00e1dn\u00edm na\u0159\u00edzen\u00edm a kter\u00e9 by mohly zp\u016fsobit zvl\u00e1\u0161\u0165 velk\u00e9 riziko, pokud by nebyly pou\u017e\u00edv\u00e1ny pod dohledem 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 tyto l\u00e9ky nebo produkty regenerativn\u00ed medic\u00edny a omezit metody reklamy na tyto l\u00e9ky nebo produkty regenerativn\u00ed medic\u00edny, kter\u00e9 jsou ur\u010deny pro ve\u0159ejnost mimo l\u00e9ka\u0159sk\u00e9 profese, a stanovit jin\u00e1 nezbytn\u00e1 opat\u0159en\u00ed k zaji\u0161t\u011bn\u00ed spr\u00e1vn\u00e9ho pou\u017eit\u00ed t\u011bchto l\u00e9k\u016f nebo produkt\u016f regenerativn\u00ed medic\u00edny.<\/p>\n\n\n\n<p>2 Ministr zdravotnictv\u00ed, pr\u00e1ce a soci\u00e1ln\u00edch v\u011bc\u00ed mus\u00ed p\u0159ed po\u017eadov\u00e1n\u00edm kabinetn\u00edho rozhodnut\u00ed o vyd\u00e1n\u00ed nebo zru\u0161en\u00ed vl\u00e1dn\u00edho na\u0159\u00edzen\u00ed stanovuj\u00edc\u00edho specifick\u00e9 nemoci podle p\u0159edchoz\u00edho odstavce vyslechnout n\u00e1zor Rady pro l\u00e9ky a potravinovou hygienu. Toto v\u0161ak neplat\u00ed pro p\u0159\u00edpady, kter\u00e9 Rada pro l\u00e9ky a potravinovou hygienu pova\u017euje za nepodstatn\u00e9.<\/p>\n<cite><a href=\"https:\/\/elaws.e-gov.go.jp\/document?lawid=335AC0000000145\" target=\"_blank\" rel=\"noreferrer noopener\">\u010cl\u00e1nek 67 Japonsk\u00e9ho z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch[ja]<\/a><\/cite><\/blockquote>\n\n\n\n<p>Term\u00edn &#8220;specifick\u00e9 nemoci&#8221; v tomto \u010dl\u00e1nku zahrnuje &#8220;rakovinu&#8221;, &#8220;sarkom&#8221; a &#8220;leukemii&#8221;. Tato ustanoven\u00ed maj\u00ed za c\u00edl omezit reklamu na l\u00e9ky a produkty regenerativn\u00ed medic\u00edny pro tyto nemoci, kter\u00e9 jsou ur\u010deny pro ve\u0159ejnost mimo l\u00e9ka\u0159sk\u00e9 profese, proto\u017ee jejich pou\u017eit\u00ed vy\u017eaduje vysokou \u00farove\u0148 odborn\u00fdch znalost\u00ed.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Zakaz_reklamy_na_nepovolene_leky_a_podobne_produkty\"><\/span>Z\u00e1kaz reklamy na nepovolen\u00e9 l\u00e9ky a podobn\u00e9 produkty<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 (Pharmaceuticals and Medical Devices Act) zakazuje reklamu na l\u00e9ky a podobn\u00e9 produkty, kter\u00e9 nez\u00edskaly povolen\u00ed.<\/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)<\/p>\n\n\n\n<p>Nikdo nesm\u00ed d\u011blat reklamu na l\u00e9ky, zdravotnick\u00e9 prost\u0159edky nebo produkty regenerativn\u00ed medic\u00edny, kter\u00e9 jsou definov\u00e1ny v \u010dl\u00e1nc\u00edch 14 odstavec 1, 23-2-5 odstavec 1 nebo 23-2-23 odstavec 1, a kter\u00e9 je\u0161t\u011b nez\u00edskaly schv\u00e1len\u00ed nebo certifikaci podle \u010dl\u00e1nk\u016f 14 odstavec 1, 19-2 odstavec 1, 23-2-5 odstavec 1, 23-2-17 odstavec 1, 23-25 odstavec 1 nebo 23-37 odstavec 1, nebo certifikaci podle \u010dl\u00e1nku 23-2-23 odstavec 1, pokud jde o jejich n\u00e1zev, zp\u016fsob v\u00fdroby, \u00fa\u010dinnost, \u00fa\u010dinky nebo vlastnosti.<\/p>\n<cite><a href=\"https:\/\/elaws.e-gov.go.jp\/document?lawid=335AC0000000145\" target=\"_blank\" rel=\"noreferrer noopener\">\u010cl\u00e1nek 68 Japonsk\u00e9ho z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch[ja]<\/a><\/cite><\/blockquote>\n\n\n\n<p>Kl\u00ed\u010dov\u00fdm bodem tohoto \u010dl\u00e1nku je, \u017ee l\u00e9ky a podobn\u00e9 produkty bez povolen\u00ed nebo certifikace nemaj\u00ed zaru\u010denou \u00fa\u010dinnost nebo \u00fa\u010dinky, a proto je jejich reklama zcela zak\u00e1z\u00e1na, aby se p\u0159ede\u0161lo neo\u010dek\u00e1van\u00fdm rizik\u016fm pro ve\u0159ejn\u00e9 zdrav\u00ed.<\/p>\n\n\n\n<p>Je t\u0159eba b\u00fdt opatrn\u00fd, proto\u017ee pokud ud\u011bl\u00e1te reklamu na l\u00e9ky a podobn\u00e9 produkty p\u0159ed z\u00edsk\u00e1n\u00edm povolen\u00ed nebo certifikace, a to i v p\u0159\u00edpad\u011b, \u017ee pozd\u011bji z\u00edskaj\u00ed povolen\u00ed nebo certifikaci a jejich obsah je stejn\u00fd, poru\u0161ujete tento \u010dl\u00e1nek.<\/p>\n\n\n\n<p>Je tak\u00e9 t\u0159eba b\u00fdt opatrn\u00fd p\u0159i prodeji &#8220;potravin&#8221;, kter\u00e9 nejsou regulov\u00e1ny Japonsk\u00fdm z\u00e1konem o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch.<\/p>\n\n\n\n<p>To proto, \u017ee i kdy\u017e se jedn\u00e1 o &#8220;potraviny&#8221;, jako jsou takzvan\u00e9 zdravotn\u00ed potraviny, mohou b\u00fdt pova\u017eov\u00e1ny za l\u00e9ky, pokud v reklam\u011b tvrd\u00edte, \u017ee &#8220;sn\u00ed\u017e\u00ed krevn\u00ed tlak&#8221; a podobn\u011b.<\/p>\n\n\n\n<p>Pokud jsou pova\u017eov\u00e1ny za l\u00e9ky, reklama je zak\u00e1z\u00e1na, pokud nez\u00edskaj\u00ed povolen\u00ed nebo certifikaci. Pokud poru\u0161\u00edte tento z\u00e1kaz, m\u016f\u017eete b\u00fdt odsouzeni k trestu odn\u011bt\u00ed svobody a\u017e na dva roky nebo pokut\u011b a\u017e 2 miliony jen\u016f.<\/p>\n\n\n\n<p>Pokud chcete v\u011bd\u011bt v\u00edce o tom, na co si d\u00e1t pozor p\u0159i reklam\u011b na dopl\u0148ky stravy, pod\u00edvejte se na n\u00e1sleduj\u00edc\u00ed \u010dl\u00e1nek spolu s t\u00edmto \u010dl\u00e1nkem.<\/p>\n\n\n\n<p>Souvisej\u00edc\u00ed \u010dl\u00e1nek: <a href=\"https:\/\/monolith.law\/corporate\/points-for-supplement-advertising\" target=\"_blank\" rel=\"noreferrer noopener\">Na co si d\u00e1t pozor p\u0159i reklam\u011b na dopl\u0148ky stravy[ja]<\/a><\/p>\n\n\n\n<p>Pokud chcete v\u011bd\u011bt v\u00edce o tom, na co si d\u00e1t pozor p\u0159i reklam\u011b na kosmetiku a zdravotn\u00ed potraviny, pod\u00edvejte se na n\u00e1sleduj\u00edc\u00ed \u010dl\u00e1nek spolu s t\u00edmto \u010dl\u00e1nkem.<\/p>\n\n\n\n<p>Souvisej\u00edc\u00ed \u010dl\u00e1nek: <a href=\"https:\/\/monolith.law\/corporate\/cosmetics-healthy-food-advertisement\" target=\"_blank\" rel=\"noreferrer noopener\">Na co si d\u00e1t pozor p\u0159i reklam\u011b na kosmetiku a zdravotn\u00ed potraviny[ja]<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Prehodnoceni_role_lekarniku_a_lekaren\"><\/span>P\u0159ehodnocen\u00ed role l\u00e9k\u00e1rn\u00edk\u016f a l\u00e9k\u00e1ren<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>L\u00e9k\u00e1rn\u00edci a l\u00e9k\u00e1rny p\u0159edepisuj\u00ed l\u00e9ky na z\u00e1klad\u011b recept\u016f od zdravotnick\u00fdch za\u0159\u00edzen\u00ed. C\u00edlem tohoto rozd\u011blen\u00ed pr\u00e1ce mezi l\u00e9ka\u0159skou a farmaceutickou p\u00e9\u010di je zajistit bezpe\u010dnost a \u00fa\u010dinnost l\u00e9\u010dby l\u00e9ky t\u00edm, \u017ee l\u00e9k\u00e1rn\u00edci a l\u00e9k\u00e1rny budou m\u00edt p\u0159ehled o stavu pacienta a o l\u00e9\u010divech, kter\u00e9 u\u017e\u00edv\u00e1.<\/p>\n\n\n\n<p>Av\u0161ak ve skute\u010dnosti se \u010dasto st\u00e1v\u00e1, \u017ee pacienti dost\u00e1vaj\u00ed sv\u00e9 l\u00e9ky v l\u00e9k\u00e1rn\u00e1ch bl\u00edzko zdravotnick\u00fdch za\u0159\u00edzen\u00ed, co\u017e komplikuje kontinu\u00e1ln\u00ed sledov\u00e1n\u00ed stavu pacienta a u\u017e\u00edvan\u00fdch l\u00e9k\u016f l\u00e9k\u00e1rn\u00edky a l\u00e9k\u00e1rnami.<\/p>\n\n\n\n<p>Proto byla v prvn\u00edm roce \u00e9ry Reiwa (2019) provedena revize japonsk\u00e9ho z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch p\u0159\u00edstroj\u00edch (Japanese Pharmaceuticals and Medical Devices Act), aby se pacienti mohli v domovsk\u00e9 oblasti c\u00edtit bezpe\u010dn\u011b p\u0159i u\u017e\u00edv\u00e1n\u00ed l\u00e9k\u016f, co\u017e vy\u017eadovalo pr\u00e1vn\u00ed \u00fapravy t\u00fdkaj\u00edc\u00ed se l\u00e9k\u00e1rn\u00edk\u016f a l\u00e9k\u00e1ren.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Zjasneni_role_lekarniku_a_lekaren\"><\/span>Zjasn\u011bn\u00ed role l\u00e9k\u00e1rn\u00edk\u016f a l\u00e9k\u00e1ren<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>P\u0159ed novelizac\u00ed Japonsk\u00e9ho z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch byla l\u00e9k\u00e1rna definov\u00e1na jako &#8220;m\u00edsto, kde l\u00e9k\u00e1rn\u00edk prov\u00e1d\u00ed \u010dinnost p\u0159edepisov\u00e1n\u00ed l\u00e9k\u016f za \u00fa\u010delem prodeje nebo poskytnut\u00ed&#8221;. Av\u0161ak po novelizaci v roce Reiwa 1 (2019), byla definov\u00e1na jako &#8220;m\u00edsto, kde l\u00e9k\u00e1rn\u00edk prov\u00e1d\u00ed \u010dinnost p\u0159edepisov\u00e1n\u00ed l\u00e9k\u016f za \u00fa\u010delem prodeje nebo poskytnut\u00ed, stejn\u011b jako poskytov\u00e1n\u00ed informac\u00ed pot\u0159ebn\u00fdch pro spr\u00e1vn\u00e9 pou\u017eit\u00ed l\u00e9k\u016f a l\u00e9\u010div a poskytov\u00e1n\u00ed odborn\u00e9ho poradenstv\u00ed na z\u00e1klad\u011b farmaceutick\u00fdch znalost\u00ed&#8221; (\u010dl\u00e1nek 2, odstavec 12 Japonsk\u00e9ho z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch).<\/p>\n\n\n\n<p>Tato novelizace explicitn\u011b uk\u00e1zala, \u017ee l\u00e9k\u00e1rny a l\u00e9k\u00e1rn\u00edci jsou odborn\u00edci, kte\u0159\u00ed poskytuj\u00ed informace a poradenstv\u00ed o l\u00e9\u010divech pacient\u016fm.<\/p>\n\n\n\n<p>V d\u016fsledku toho bylo l\u00e9k\u00e1rn\u00e1m a l\u00e9k\u00e1rn\u00edk\u016fm ulo\u017eeno nejen p\u0159edepisov\u00e1n\u00ed l\u00e9k\u016f, ale tak\u00e9 povinnost poskytovat pokyny pro u\u017e\u00edv\u00e1n\u00ed l\u00e9k\u016f po p\u0159edepisov\u00e1n\u00ed a sledovat pr\u016fb\u011b\u017en\u00fd stav u\u017e\u00edv\u00e1n\u00ed l\u00e9k\u016f pacienty. Bylo tak\u00e9 stanoveno, \u017ee je jejich povinnost\u00ed usilovat o zp\u011btnou vazbu na l\u00e9ka\u0159e p\u0159edepisuj\u00edc\u00edho l\u00e9ky o stavu u\u017e\u00edv\u00e1n\u00ed l\u00e9k\u016f pacientem.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"System_certifikovanych_lekaren\"><\/span>Syst\u00e9m certifikovan\u00fdch l\u00e9k\u00e1ren<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>V roce Reiwa 1 (2019) byly v r\u00e1mci novely zavedeny n\u00e1zvy &#8220;L\u00e9k\u00e1rna spolupracuj\u00edc\u00ed s komunitou&#8221; a &#8220;L\u00e9k\u00e1rna spolupracuj\u00edc\u00ed se specializovan\u00fdmi zdravotnick\u00fdmi za\u0159\u00edzen\u00edmi&#8221;. Tyto n\u00e1zvy jsou ur\u010deny k tomu, aby explicitn\u011b uk\u00e1zaly, \u017ee l\u00e9k\u00e1rny maj\u00ed specifick\u00e9 funkce, co\u017e umo\u017e\u0148uje pacient\u016fm vybrat si l\u00e9k\u00e1rnu, kter\u00e1 je pro n\u011b nejvhodn\u011bj\u0161\u00ed. O\u010dek\u00e1v\u00e1 se, \u017ee to usnadn\u00ed pochopen\u00ed situace pacienta, co\u017e bylo o\u010dek\u00e1v\u00e1no ji\u017e d\u0159\u00edve.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Co_je_to_lekarna_spolupracujici_s_komunitou\"><\/span>Co je to l\u00e9k\u00e1rna spolupracuj\u00edc\u00ed s komunitou?<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<figure class=\"wp-block-image is-resized\"><img decoding=\"async\" src=\"https:\/\/lh3.googleusercontent.com\/pcdPemdH4-kMLwQkMA9WSZwf-4ZUfYMowXvdm1jLr0JesPBG1BI3MwJNcoHvtUAgMhiTTRpT4qvPgBuGaE_BH5f6twZB0gPBJ9mhOu7Yyom72bMRCCZtVZrxJTb-XUqHHqf29dHCGfeSukci7dTq4e4\" alt=\"Co je to l\u00e9k\u00e1rna spolupracuj\u00edc\u00ed s komunitou?\" style=\"width:789px;height:468px\" \/><\/figure>\n\n\n\n<p class=\"has-text-align-right\"><a href=\"https:\/\/www.mhlw.go.jp\/content\/11121000\/000883897.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Materi\u00e1ly z 11. setk\u00e1n\u00ed o vzd\u011bl\u00e1v\u00e1n\u00ed a zlep\u0161ov\u00e1n\u00ed kvalifikace l\u00e9k\u00e1rn\u00edk\u016f Ministerstva zdravotnictv\u00ed, pr\u00e1ce a soci\u00e1ln\u00edch v\u011bc\u00ed (20. ledna Reiwa 4\/2022)[ja]<\/a><\/p>\n\n\n\n<p>L\u00e9k\u00e1rna spolupracuj\u00edc\u00ed s komunitou (podle \u010dl\u00e1nku 6 odst. 2 japonsk\u00e9ho z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch p\u0159\u00edstroj\u00edch) je l\u00e9k\u00e1rna, kter\u00e1 spolupracuje s jin\u00fdmi zdravotnick\u00fdmi za\u0159\u00edzen\u00edmi, jako jsou ordinace nebo pe\u010dovatelsk\u00e9 domy, centralizovan\u011b spravuje informace o stavu l\u00e9\u010dby pacient\u016f a je schopna kontinu\u00e1ln\u011b spolupracovat.<\/p>\n\n\n\n<p>Mezi po\u017eadavky na l\u00e9k\u00e1rny spolupracuj\u00edc\u00ed s komunitou pat\u0159\u00ed, aby spl\u0148ovaly normy stanoven\u00e9 Ministerstvem zdravotnictv\u00ed, pr\u00e1ce a soci\u00e1ln\u00edch v\u011bc\u00ed v oblasti sd\u00edlen\u00ed informac\u00ed, no\u010dn\u00ed a sv\u00e1te\u010dn\u00ed slu\u017eby a podpora dom\u00e1c\u00ed zdravotn\u00ed p\u00e9\u010de.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Co_je_to_lekarna_spolupracujici_se_specializovanymi_zdravotnickymi_zarizenimi\"><\/span>Co je to l\u00e9k\u00e1rna spolupracuj\u00edc\u00ed se specializovan\u00fdmi zdravotnick\u00fdmi za\u0159\u00edzen\u00edmi?<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" src=\"https:\/\/lh6.googleusercontent.com\/GvV25e9DI8Nkl4JfReuE5kDbK7TT6tb7Yt_s-M4ooT-6Fj4ZDXuY9gFf3E_er1uFkdBSDhEfu4gFfFwpf5Y_PsC9vdsyRRp73JSDy01u6YJV-fwrMgUudkFWWjlwO_ozrWDXES0UdMyr-UYTrAJIOwk\" alt=\"Co je to l\u00e9k\u00e1rna spolupracuj\u00edc\u00ed se specializovan\u00fdmi zdravotnick\u00fdmi za\u0159\u00edzen\u00edmi?\" \/><\/figure>\n\n\n\n<p class=\"has-text-align-right\"><a href=\"https:\/\/www.mhlw.go.jp\/content\/11121000\/000883897.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Materi\u00e1ly z 11. setk\u00e1n\u00ed o vzd\u011bl\u00e1v\u00e1n\u00ed a zlep\u0161ov\u00e1n\u00ed kvalifikace l\u00e9k\u00e1rn\u00edk\u016f Ministerstva zdravotnictv\u00ed, pr\u00e1ce a soci\u00e1ln\u00edch v\u011bc\u00ed (20. ledna Reiwa 4\/2022)[ja]<\/a><\/p>\n\n\n\n<p>L\u00e9k\u00e1rna spolupracuj\u00edc\u00ed se specializovan\u00fdmi zdravotnick\u00fdmi za\u0159\u00edzen\u00edmi (podle \u010dl\u00e1nku 6 odst. 3 japonsk\u00e9ho z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch p\u0159\u00edstroj\u00edch) je l\u00e9k\u00e1rna, kter\u00e1 je uzn\u00e1na za za\u0159\u00edzen\u00ed s funkc\u00ed poskytov\u00e1n\u00ed pokyn\u016f na z\u00e1klad\u011b specializovan\u00fdch farmaceutick\u00fdch znalost\u00ed ve spolupr\u00e1ci s jin\u00fdmi zdravotnick\u00fdmi za\u0159\u00edzen\u00edmi.<\/p>\n\n\n\n<p>L\u00e9k\u00e1rna spolupracuj\u00edc\u00ed se specializovan\u00fdmi zdravotnick\u00fdmi za\u0159\u00edzen\u00edmi je instituce, kter\u00e1 sd\u00edl\u00ed l\u00e9\u010debn\u00e9 postupy se specializovan\u00fdmi zdravotnick\u00fdmi za\u0159\u00edzen\u00edmi a umo\u017e\u0148uje poskytov\u00e1n\u00ed specializovan\u00e9 l\u00e9\u010dby i doma, pokud je vy\u017eadov\u00e1no kontinu\u00e1ln\u00ed poskytov\u00e1n\u00ed specializovan\u00fdch pokyn\u016f.<\/p>\n\n\n\n<p>V sou\u010dasn\u00e9 dob\u011b je c\u00edlem pouze rakovina, ale o\u010dek\u00e1v\u00e1 se, \u017ee se rozsah c\u00edlen\u00fdch onemocn\u011bn\u00ed roz\u0161\u00ed\u0159\u00ed, proto\u017ee certifikace je ud\u011blov\u00e1na pro ka\u017edou kategorii nemoc\u00ed stanovenou na\u0159\u00edzen\u00edm Ministerstva zdravotnictv\u00ed, pr\u00e1ce a soci\u00e1ln\u00edch v\u011bc\u00ed.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Online_pokyny_pro_uzivani_leku\"><\/span>Online pokyny pro u\u017e\u00edv\u00e1n\u00ed l\u00e9k\u016f<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Online l\u00e9ka\u0159sk\u00e9 konzultace byly mo\u017en\u00e9 ji\u017e d\u0159\u00edve a byla provedena opat\u0159en\u00ed zam\u011b\u0159en\u00e1 na jejich roz\u0161\u00ed\u0159en\u00ed.<\/p>\n\n\n\n<p>V\u0161ak podle p\u016fvodn\u00edho zn\u011bn\u00ed Japonsk\u00e9ho z\u00e1kona o l\u00e9\u010divech (\u85ac\u6a5f\u6cd5) bylo nutn\u00e9 p\u0159i p\u0159edepisov\u00e1n\u00ed l\u00e9k\u016f na z\u00e1klad\u011b receptu poskytnout pokyny pro u\u017e\u00edv\u00e1n\u00ed l\u00e9k\u016f osobn\u011b. I kdy\u017e byla provedena online konzultace, pacienti museli nav\u0161t\u00edvit l\u00e9k\u00e1rnu, co\u017e znamen\u00e1, \u017ee v\u00fdhody online konzultace nebyly pln\u011b vyu\u017eity.<\/p>\n\n\n\n<p>Proto bylo v r\u00e1mci revize Japonsk\u00e9ho z\u00e1kona o l\u00e9\u010divech v roce Reiwa 1 (2019) stanoveno, \u017ee pokud jsou spln\u011bny ur\u010dit\u00e9 podm\u00ednky, m\u016f\u017ee b\u00fdt povoleno poskytov\u00e1n\u00ed pokyn\u016f pro u\u017e\u00edv\u00e1n\u00ed l\u00e9k\u016f online (\u010dl\u00e1nek 9, odstavec 3, odstavec 1 Japonsk\u00e9ho z\u00e1kona o l\u00e9\u010divech).<\/p>\n\n\n\n<p>P\u016fvodn\u00edm \u00fa\u010delem po\u017eadavku na osobn\u00ed pokyny pro u\u017e\u00edv\u00e1n\u00ed l\u00e9k\u016f bylo zajistit, aby pacienti spr\u00e1vn\u011b u\u017e\u00edvali l\u00e9ky a aby byla zaji\u0161t\u011bna jejich bezpe\u010dnost a \u00fa\u010dinnost prost\u0159ednictv\u00edm vysv\u011btlen\u00ed o d\u00e1vkov\u00e1n\u00ed a vedlej\u0161\u00edch \u00fa\u010dinc\u00edch od l\u00e9k\u00e1rn\u00edka s odborn\u00fdmi znalostmi.<\/p>\n\n\n\n<p>Proto jsou mezi podm\u00ednkami pro online pokyny pro u\u017e\u00edv\u00e1n\u00ed l\u00e9k\u016f stanoveny nap\u0159\u00edklad skute\u010dnosti, \u017ee l\u00e9k byl ji\u017e p\u0159edeps\u00e1n osobn\u011b, \u017ee mezi l\u00e9k\u00e1rn\u00edkem a pacientem byl vytvo\u0159en vztah d\u016fv\u011bry, \u017ee byl vytvo\u0159en pl\u00e1n pokyn\u016f pro u\u017e\u00edv\u00e1n\u00ed l\u00e9k\u016f se souhlasem pacienta a \u017ee pokyny pro u\u017e\u00edv\u00e1n\u00ed l\u00e9k\u016f jsou poskytov\u00e1ny na z\u00e1klad\u011b tohoto pl\u00e1nu.<\/p>\n\n\n\n<p>Podle ozn\u00e1men\u00ed od \u0159editele \u00da\u0159adu pro l\u00e9ky a \u017eivotn\u00ed prost\u0159ed\u00ed Ministerstva zdravotnictv\u00ed, pr\u00e1ce a soci\u00e1ln\u00edch v\u011bc\u00ed se pl\u00e1nuje pravideln\u00e9 p\u0159ehodnocen\u00ed provozu online pokyn\u016f pro u\u017e\u00edv\u00e1n\u00ed l\u00e9k\u016f s ohledem na budouc\u00ed roz\u0161\u00ed\u0159en\u00ed online konzultac\u00ed a pokyn\u016f pro u\u017e\u00edv\u00e1n\u00ed l\u00e9k\u016f a technologick\u00e9 inovace.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Co_je_to_system_pokut_pridany_v_ramci_novely_Japonskeho_zakona_o_lecivech_a_zdravotnickych_prostredcich\"><\/span>Co je to syst\u00e9m pokut p\u0159idan\u00fd v r\u00e1mci novely 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\"><img decoding=\"async\" src=\"https:\/\/lh5.googleusercontent.com\/boSWvu6tPOmogxdIQjoi0JYIkg0C0kkBSQZAkv_PcY-Wx02L01-7G5Ayw0tIdnWM5exaIgYUAWordimL2Ig5d1M1XEhMiGa-MypNhTRHQSId7Ed_aL3H6ZqTx--z3yJZ8uaQJy5XrD61sA0Nwa352dI\" alt=\"Co je to syst\u00e9m pokut p\u0159idan\u00fd v r\u00e1mci novely Japonsk\u00e9ho z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch\" \/><\/figure>\n\n\n\n<p>P\u0159ed novelizac\u00ed Japonsk\u00e9ho z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch byly osoby poru\u0161uj\u00edc\u00ed reklamn\u00ed regulace, v\u010detn\u011b fale\u0161n\u00e9 a p\u0159ehnan\u00e9 reklamy, trest\u00e1ny trestem odn\u011bt\u00ed svobody a pokutami. Nicm\u00e9n\u011b, v\u00fd\u0161e pokut byla maxim\u00e1ln\u011b 2 miliony jen\u016f, co\u017e je mal\u00e1 \u010d\u00e1stka ve srovn\u00e1n\u00ed s neopr\u00e1vn\u011bn\u00fdm ziskem z\u00edskan\u00fdm poru\u0161en\u00edm reklamn\u00edch regulac\u00ed, a proto bylo pouk\u00e1z\u00e1no na mal\u00fd odstra\u0161uj\u00edc\u00ed \u00fa\u010dinek.<\/p>\n\n\n\n<p>Proto byl v r\u00e1mci novely Japonsk\u00e9ho z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch v roce Reiwa 1 (2019) zaveden syst\u00e9m pokut jako sou\u010d\u00e1st &#8220;zaji\u0161t\u011bn\u00ed d\u016fv\u011bry prost\u0159ednictv\u00edm vytvo\u0159en\u00ed syst\u00e9mu pro dodr\u017eov\u00e1n\u00ed z\u00e1kon\u016f&#8221;. Syst\u00e9m pokut je syst\u00e9m, kter\u00fd na\u0159izuje platbu pokut osob\u00e1m, kter\u00e9 se dopustily fale\u0161n\u00e9 a p\u0159ehnan\u00e9 reklamy na l\u00e9ky a podobn\u00e9 produkty.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Pokuta_cini_45_z_obratu\"><\/span>Pokuta \u010din\u00ed 4,5% z obratu<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>V\u00fd\u0161e pokuty je stanovena na 4,5% z obratu l\u00e9k\u016f a podobn\u00fdch produkt\u016f v ur\u010dit\u00e9m obdob\u00ed po proveden\u00ed nepravdiv\u00e9 nebo p\u0159ehnan\u00e9 reklamy. Proto se, na rozd\u00edl od d\u0159\u00edv\u011bj\u0161\u00edch pau\u0161\u00e1ln\u00edch pokut, v\u00fd\u0161e m\u011bn\u00ed v z\u00e1vislosti na zisku z\u00edskan\u00e9m neleg\u00e1ln\u00edmi \u010dinnostmi, co\u017e se pova\u017euje za vysok\u00fd odstra\u0161uj\u00edc\u00ed \u00fa\u010dinek.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Regulovane_subjekty\"><\/span>Regulovan\u00e9 subjekty<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u010cl\u00e1nek 66 odstavec 1 Japonsk\u00e9ho z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch (Pharmaceuticals and Medical Devices Act) stanovuje, \u017ee subjekty, kter\u00e9 nesm\u00ed prov\u00e1d\u011bt fale\u0161nou nebo p\u0159ehnanou reklamu, jsou definov\u00e1ny jako &#8220;kdokoli&#8221;. Proto nejen v\u00fdrobci a prodejci l\u00e9k\u016f a podobn\u00fdch produkt\u016f, ale tak\u00e9 reklamn\u00ed m\u00e9dia, reklamn\u00ed agentury a jednotlivci, jako jsou affiliate market\u00e9\u0159i a influenceri, kte\u0159\u00ed se pod\u00edlej\u00ed na reklam\u011b, mohou b\u00fdt potrest\u00e1ni pokutou za takov\u00e9 jedn\u00e1n\u00ed.<\/p>\n\n\n\n<p>Av\u0161ak, Ministerstvo zdravotnictv\u00ed, pr\u00e1ce a soci\u00e1ln\u00edch v\u011bc\u00ed Japonska vysv\u011btluje &#8220;transakce&#8221;, kter\u00e9 mohou b\u00fdt p\u0159edm\u011btem pokuty, n\u00e1sledovn\u011b:<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>(Ot\u00e1zky a odpov\u011bdi t\u00fdkaj\u00edc\u00ed se zp\u016fsobu v\u00fdpo\u010dtu celkov\u00e9 \u010d\u00e1stky ceny pro pokutu)<\/p>\n\n\n\n<p>Jde nap\u0159\u00edklad o transakce prov\u00e1d\u011bn\u00e9 v\u00fdrobci, velkoobchodn\u00edmi prodejci, prodejci atd. Nav\u00edc, proto\u017ee se neomezuje pouze na transakce prov\u00e1d\u011bn\u00e9 subjekty, kter\u00e9 obdr\u017eely povolen\u00ed k podnik\u00e1n\u00ed na z\u00e1klad\u011b Japonsk\u00e9ho z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch, zahrnuje tak\u00e9 transakce prov\u00e1d\u011bn\u00e9 subjekty, kter\u00e9 prod\u00e1vaj\u00ed kosmetiku nebo l\u00e9ky mimo l\u00e9k\u00e1rny, kter\u00e9 ji\u017e byly uvedeny na trh. Nicm\u00e9n\u011b, transakce prov\u00e1d\u011bn\u00e9 nap\u0159\u00edklad novinami, \u010dasopisy, vys\u00edlac\u00edmi spole\u010dnostmi, internetov\u00fdmi m\u00e9dii a dal\u0161\u00edmi reklamn\u00edmi m\u00e9dii, stejn\u011b jako reklamn\u00ed agentury a poskytovatel\u00e9 slu\u017eeb, kte\u0159\u00ed zprost\u0159edkov\u00e1vaj\u00ed nebo p\u0159eb\u00edraj\u00ed reklamu pro tyto reklamn\u00ed m\u00e9dia, nejsou zahrnuty.<\/p>\n<cite><a href=\"https:\/\/www.mhlw.go.jp\/content\/000801630.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Ministerstvo zdravotnictv\u00ed, pr\u00e1ce a soci\u00e1ln\u00edch v\u011bc\u00ed Japonska, \u00da\u0159ad pro l\u00e9ky a \u017eivotn\u00ed prost\u0159ed\u00ed, Administrativn\u00ed komunikace, 6. \u010dervence 2021[ja]<\/a><\/cite><\/blockquote>\n\n\n\n<p>Takto, syst\u00e9m pokut se vztahuje na v\u00fdrobce, velkoobchodn\u00ed prodejce a prodejce, kte\u0159\u00ed p\u0159\u00edmo obchoduj\u00ed s l\u00e9ky a podobn\u00fdmi produkty, ale nezahrnuje reklamn\u00ed agentury, reklamn\u00ed m\u00e9dia a jednotlivce, jako jsou affiliate market\u00e9\u0159i a influenceri, kte\u0159\u00ed se na reklam\u011b pod\u00edlej\u00ed.<\/p>\n\n\n\n<p>Av\u0161ak, v d\u016fsledku zm\u011bn z roku 2019 (prvn\u00ed rok \u00e9ry Reiwa), byly p\u0159id\u00e1ny tresty a na\u0159\u00edzen\u00ed pro ty, kte\u0159\u00ed prov\u00e1d\u011bj\u00ed fale\u0161nou nebo p\u0159ehnanou reklamu, tak\u017ee je t\u0159eba b\u00fdt opatrn\u011bj\u0161\u00ed ne\u017e d\u0159\u00edve p\u0159i zapojen\u00ed do reklamy na l\u00e9ky a podobn\u00e9 produkty.<\/p>\n\n\n\n<p>Souvisej\u00edc\u00ed \u010dl\u00e1nek: <a href=\"https:\/\/monolith.law\/?p=49848\" target=\"_blank\" rel=\"noreferrer noopener\">Co je to syst\u00e9m pokut podle z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch? Vysv\u011btlen\u00ed \u010dinnost\u00ed, kter\u00e9 mohou b\u00fdt p\u0159edm\u011btem pokuty, a p\u0159\u00edpad\u016f, kdy mohou b\u00fdt pokuty sn\u00ed\u017eeny[ja]<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Dodatecne_prikazy_v_ramci_zmeny_zakona_o_lecivech_a_zdravotnickych_prostredcich\"><\/span>Dodate\u010dn\u00e9 p\u0159\u00edkazy v r\u00e1mci zm\u011bny z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Jak bylo uvedeno v\u00fd\u0161e, v r\u00e1mci zm\u011bny japonsk\u00e9ho z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch (Japanese Pharmaceutical and Medical Device Act) v roce Reiwa 1 (2019), byly p\u0159id\u00e1ny dodate\u010dn\u00e9 p\u0159\u00edkazy pro ty, kte\u0159\u00ed prov\u00e1d\u011bj\u00ed fale\u0161nou nebo p\u0159ehnanou reklamu. Dodate\u010dn\u00fd p\u0159\u00edkaz je jedn\u00edm z administrativn\u00edch opat\u0159en\u00ed, kter\u00e9 st\u00e1t nebo m\u00edstn\u00ed samospr\u00e1va vyd\u00e1v\u00e1 proti t\u011bm, kte\u0159\u00ed poru\u0161ili z\u00e1kony, aby p\u0159im\u011bli k zastaven\u00ed poru\u0161ov\u00e1n\u00ed a p\u0159ijet\u00ed opat\u0159en\u00ed k zabr\u00e1n\u011bn\u00ed opakov\u00e1n\u00ed.<\/p>\n\n\n\n<p>Obsah dodate\u010dn\u00e9ho p\u0159\u00edkazu lze shrnout do t\u0159\u00ed kategori\u00ed:<\/p>\n\n\n\n<ul>\n<li>Zastaven\u00ed neleg\u00e1ln\u00ed reklamy<\/li>\n\n\n\n<li>Ve\u0159ejn\u00e9 ozn\u00e1men\u00ed t\u00fdkaj\u00edc\u00ed se opat\u0159en\u00ed pot\u0159ebn\u00fdch k zabr\u00e1n\u011bn\u00ed opakov\u00e1n\u00ed neleg\u00e1ln\u00edho jedn\u00e1n\u00ed<\/li>\n\n\n\n<li>Opat\u0159en\u00ed dostate\u010dn\u00e1 k zabr\u00e1n\u011bn\u00ed vzniku ve\u0159ejn\u00e9ho zdravotn\u00edho rizika<\/li>\n<\/ul>\n\n\n\n<p>Z t\u011bchto, ve zm\u011bn\u011b z roku Reiwa 1 (2019), bylo p\u0159id\u00e1no &#8220;ve\u0159ejn\u00e9 ozn\u00e1men\u00ed&#8221;, co\u017e znamen\u00e1, \u017ee efektivita odstra\u0161en\u00ed od neleg\u00e1ln\u00ed reklamy byla zv\u00fd\u0161ena t\u00edm, \u017ee byli ti, kte\u0159\u00ed prov\u00e1d\u011bli neleg\u00e1ln\u00ed reklamu, ve\u0159ejn\u011b identifikov\u00e1ni.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Opatreni_ktera_by_mely_podniky_prijmout_v_dusledku_zmeny_Japonskeho_zakona_o_lecivech_a_zdravotnickych_prostredcich\"><\/span>Opat\u0159en\u00ed, kter\u00e1 by m\u011bly podniky p\u0159ijmout v d\u016fsledku zm\u011bny 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<p>Japonsk\u00fd z\u00e1kon o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch se t\u00fdk\u00e1 mnoha produkt\u016f souvisej\u00edc\u00edch s lidsk\u00fdm zdrav\u00edm, a proto je nezbytn\u00e9, aby provozovatel\u00e9 t\u011bchto produkt\u016f spr\u00e1vn\u011b pochopili i jeho \u010d\u00e1ste\u010dn\u00e9 zm\u011bny.<\/p>\n\n\n\n<p>Pokud by bylo zji\u0161t\u011bno poru\u0161en\u00ed tohoto z\u00e1kona a byly by vyd\u00e1ny p\u0159\u00edkazy k zastaven\u00ed \u010dinnosti nebo k zaplacen\u00ed pokut, mohlo by to v\u00e9st nejen k finan\u010dn\u00edm v\u00fddaj\u016fm, ale tak\u00e9 k v\u00fdrazn\u00e9mu po\u0161kozen\u00ed soci\u00e1ln\u00ed d\u016fv\u011bry a image podniku nebo produktu. Jak\u00e9 tedy opat\u0159en\u00ed by m\u011bly podniky p\u0159ijmout, aby nedo\u0161lo k poru\u0161en\u00ed tohoto z\u00e1kona?<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Znovu_zkontrolujte_reklamu_na_vlastni_vyrobky\"><\/span>Znovu zkontrolujte reklamu na vlastn\u00ed v\u00fdrobky<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Nejprve zkontrolujte, zda reklama na va\u0161e v\u00fdrobky nespad\u00e1 do n\u00e1sleduj\u00edc\u00edch dvou zak\u00e1zan\u00fdch kategori\u00ed.<\/p>\n\n\n\n<ul>\n<li>Z\u00e1kaz l\u017eiv\u00e9 a p\u0159ehnan\u00e9 reklamy<\/li>\n\n\n\n<li>Z\u00e1kaz reklamy na neschv\u00e1len\u00e9 l\u00e9ky atd.<\/li>\n<\/ul>\n\n\n\n<p>P\u0159i t\u00e9to kontrole je vhodn\u00e9 se \u0159\u00eddit sm\u011brnicemi vytvo\u0159en\u00fdmi Ministerstvem zdravotnictv\u00ed, pr\u00e1ce a soci\u00e1ln\u00edch v\u011bc\u00ed mimo Japonsk\u00fd z\u00e1kon o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch a zkontrolovat, zda reklama neobsahuje neleg\u00e1ln\u00ed obsah.<\/p>\n\n\n\n<p>Je t\u0159eba si uv\u011bdomit, \u017ee reklama m\u016f\u017ee b\u00fdt neleg\u00e1ln\u00ed, a\u0165 u\u017e je jej\u00ed v\u00fdraz explicitn\u00ed nebo implicitn\u00ed. To znamen\u00e1, \u017ee i kdy\u017e v\u00fdraz nen\u00ed p\u0159\u00edmo\u010dar\u00fd, pokud nazna\u010duje obsah, kter\u00fd spad\u00e1 do zak\u00e1zan\u00fdch kategori\u00ed, m\u016f\u017ee b\u00fdt pova\u017eov\u00e1n za poru\u0161en\u00ed.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Vytvorte_vlastni_smernice_a_informujte_o_nich\"><\/span>Vytvo\u0159te vlastn\u00ed sm\u011brnice a informujte o nich<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Reklama na v\u00fdrobky je proces, do kter\u00e9ho se zapojuje mnoho podnik\u016f a jednotlivc\u016f, od pl\u00e1nov\u00e1n\u00ed a v\u00fdroby po publikaci v m\u00e9di\u00edch. I kdy\u017e inzerent spr\u00e1vn\u011b rozum\u00ed Japonsk\u00e9mu z\u00e1konu o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch, nelze \u00fapln\u011b zabr\u00e1nit poru\u0161en\u00ed.<\/p>\n\n\n\n<p>Doporu\u010dujeme proto vytvo\u0159it vlastn\u00ed sm\u011brnice, kter\u00e9 shrnuj\u00ed ustanoven\u00ed Japonsk\u00e9ho z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch a souvisej\u00edc\u00ed polo\u017eky sm\u011brnic t\u00fdkaj\u00edc\u00edch se reklamy na vlastn\u00ed v\u00fdrobky, a sd\u00edlet je se v\u0161emi z\u00fa\u010dastn\u011bn\u00fdmi stranami.<\/p>\n\n\n\n<p>Je tak\u00e9 nutn\u00e9 instruovat reklamn\u00ed agentury, aby se postaraly o \u0161\u00ed\u0159en\u00ed t\u011bchto sm\u011brnic mezi v\u00fdrobn\u00edmi spole\u010dnostmi, reklamn\u00edmi tv\u016frci a dokonce i affiliate market\u00e9ry.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Shrnuti_Nejasnosti_vyplyvajici_ze_zmeny_Japonskeho_zakona_o_lecivech_a_zdravotnickych_prostredcich_by_mely_byt_konzultovany_s_pravnikem\"><\/span>Shrnut\u00ed: Nejasnosti vypl\u00fdvaj\u00edc\u00ed ze zm\u011bny Japonsk\u00e9ho z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch by m\u011bly b\u00fdt konzultov\u00e1ny s pr\u00e1vn\u00edkem<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" src=\"https:\/\/lh3.googleusercontent.com\/NlUkUjIZjMHLiT44NCTF7kC51iWfXDmbpDdZ0Vulo8TtU5M47wEp-m8AtzejZqbp7gLm9wyFfdEbf1GnLgudeRGqSN71Ls76aR9DdadF0gV0IMJvVOd2c8wdLvmn342NJbUHDSD4atsuxNUpdxjn_Y4\" alt=\"Shrnut\u00ed: Nejasnosti vypl\u00fdvaj\u00edc\u00ed ze zm\u011bny Japonsk\u00e9ho z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch by m\u011bly b\u00fdt konzultov\u00e1ny s pr\u00e1vn\u00edkem\" \/><\/figure>\n\n\n\n<p>Dosud jsme se zam\u011b\u0159ili na revizi Japonsk\u00e9ho z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch z roku Reiwa 1 (2019), zejm\u00e9na na p\u0159ehodnocen\u00ed role l\u00e9k\u00e1ren a l\u00e9k\u00e1rn\u00edk\u016f a na syst\u00e9m pokut.<\/p>\n\n\n\n<p>Obzvl\u00e1\u0161t\u011b syst\u00e9m pokut m\u016f\u017ee p\u0159edstavovat velk\u00e9 riziko pro firmy zab\u00fdvaj\u00edc\u00ed se l\u00e9\u010divy a podobn\u00fdmi produkty, a je tedy nezbytn\u00e9 ho spr\u00e1vn\u011b pochopit.<\/p>\n\n\n\n<p>Doporu\u010dujeme prov\u00e1d\u011bt kontroly st\u00e1vaj\u00edc\u00edch reklam a vytv\u00e1\u0159et a \u0161\u00ed\u0159it vlastn\u00ed pokyny jako opat\u0159en\u00ed proti poru\u0161en\u00ed Japonsk\u00e9ho z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch. Av\u0161ak rozhodnut\u00ed, zda vyj\u00e1d\u0159en\u00ed v reklam\u011b poru\u0161uje regulaci tohoto z\u00e1kona, m\u016f\u017ee b\u00fdt pro jednotlivce obt\u00ed\u017en\u00e9. Proto v\u00e1s pros\u00edme, abyste se p\u0159i kontrole reklam a vytv\u00e1\u0159en\u00ed pokyn\u016f obr\u00e1tili na pr\u00e1vn\u00edka s bohat\u00fdmi odborn\u00fdmi znalostmi a zku\u0161enostmi.<\/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. Na\u0161e kancel\u00e1\u0159 poskytuje slu\u017eby, jako je pr\u00e1vn\u00ed kontrola \u010dl\u00e1nk\u016f a LP, vytv\u00e1\u0159en\u00ed pokyn\u016f a kontrola vzork\u016f pro provozovatele m\u00e9di\u00ed, provozovatele recenzn\u00edch str\u00e1nek, reklamn\u00ed agentury, D2C a v\u00fdrobce kosmetiky, jako jsou dopl\u0148ky stravy, kliniky a provozovatele ASP. 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>Novela z\u00e1kona o l\u00e9\u010divech a zdravotnick\u00fdch prost\u0159edc\u00edch, kter\u00e1 byla vyhl\u00e1\u0161ena 4. prosince prvn\u00edho roku \u00e9ry Reiwa (2019), a jej\u00ed\u017e postupn\u00e9 zav\u00e1d\u011bn\u00ed je pl\u00e1nov\u00e1no, je tak rozs\u00e1hl\u00e1, \u017ee je ozna\u010dov\u00e1na jako &#038; [&hellip;]<\/p>\n","protected":false},"author":32,"featured_media":64153,"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\/61592"}],"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=61592"}],"version-history":[{"count":2,"href":"https:\/\/monolith.law\/cs\/wp-json\/wp\/v2\/posts\/61592\/revisions"}],"predecessor-version":[{"id":64154,"href":"https:\/\/monolith.law\/cs\/wp-json\/wp\/v2\/posts\/61592\/revisions\/64154"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/monolith.law\/cs\/wp-json\/wp\/v2\/media\/64153"}],"wp:attachment":[{"href":"https:\/\/monolith.law\/cs\/wp-json\/wp\/v2\/media?parent=61592"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/monolith.law\/cs\/wp-json\/wp\/v2\/categories?post=61592"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/monolith.law\/cs\/wp-json\/wp\/v2\/tags?post=61592"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}