{"id":2223,"date":"2022-08-12T08:07:58","date_gmt":"2022-08-12T08:07:58","guid":{"rendered":"https:\/\/csiag.eu\/?p=2223"},"modified":"2023-01-20T17:02:42","modified_gmt":"2023-01-20T17:02:42","slug":"narizeni-pozastavuje-platnost-zakonu-a-predpisu-pro-vakciny-corona","status":"publish","type":"post","link":"https:\/\/csiag.eu\/cs\/blog\/2022\/08\/12\/verordnung-setzt-gesetze-und-verordnungen-fuer-corona-impftstoffe-ausser-kraft\/","title":{"rendered":"Vyhl\u00e1\u0161ka pozastavuje platnost z\u00e1kon\u016f a p\u0159edpis\u016f pro vakc\u00edny proti koronavir\u016fm"},"content":{"rendered":"Doba \u010dten\u00ed<\/span> 3<\/span> minuty<\/span><\/span>\n

Na\u0159\u00edzen\u00ed Na\u0159\u00edzen\u00ed o zaji\u0161t\u011bn\u00ed z\u00e1sobov\u00e1n\u00ed zdravotnick\u00fdch pot\u0159eb (MedBVSV)<\/strong> od 26.05.2020<\/p>\n\n\n\n

Posledn\u00ed zm\u011bna \u010dl. 1 V v. 9.3.2022 BAnz AT 10.03.2022 V1

<\/p>\n\n\n\n

Byly p\u0159ijaty tyto z\u00e1kony a na\u0159\u00edzen\u00ed<\/strong> \u00a7 3 odst. 1 MedBVSV<\/u><\/strong><\/a> pro koronov\u00e9 vakc\u00edny byla pozastavena:<\/strong><\/p>\n\n\n\n

Na spolkov\u00e9 ministerstvo se nevztahuje \u00a7 8 odst. 3, \u00a7 10, 11, 11a a 21 odst. 1, \u00a7 21a odst. 1 a 9, \u00a7 32 odst. 1, \u00a7 43, 47 a 72 odst. 1 a 4, \u00a7 72a odst. 1, \u00a7 72b odst. 1 a 2, \u00a7 72c odst. 1, \u00a7 73a, 78 a 94 z\u00e1kona o l\u00e9\u010divech (AMG) a \u00a7 4a odst. 1 a \u00a7 6 odst. 1 na\u0159\u00edzen\u00ed o obchodu s l\u00e9\u010div\u00fdmi p\u0159\u00edpravky (AM-HandelsV), j\u00edm pov\u011b\u0159en\u00e9 subjekty a na osoby, od nich\u017e spolkov\u00e9 ministerstvo nebo j\u00edm pov\u011b\u0159en\u00fd subjekt nakupuje l\u00e9\u010div\u00e9 p\u0159\u00edpravky, pokud spolkov\u00e9 ministerstvo nebo j\u00edm pov\u011b\u0159en\u00fd subjekt nakupuje l\u00e9\u010div\u00e9 p\u0159\u00edpravky nebo \u00fa\u010dinn\u00e9 l\u00e1tky, v\u00fdchoz\u00ed a pomocn\u00e9 l\u00e1tky podle \u00a7 2 odst. 1 a uv\u00e1d\u00ed je na trh.<\/em><\/p>\n\n\n\n

N\u011bmeck\u00fd z\u00e1kon o l\u00e9\u010div\u00fdch p\u0159\u00edpravc\u00edch (AMG)<\/strong><\/p>\n\n\n\n

\u00a7 8 odst. 3 AMG (z\u00e1kaz uv\u00e1d\u011bn\u00ed pro\u0161l\u00fdch l\u00e9\u010div\u00fdch p\u0159\u00edpravk\u016f na trh)<\/strong><\/p>\n\n\n\n

Vakc\u00edny s pro\u0161lou dobou platnosti mohou b\u00fdt uvedeny na trh a o\u010dkov\u00e1ny.<\/em><\/p>\n\n\n\n

\u00a710 AMG (povinnost ozna\u010dov\u00e1n\u00ed l\u00e9\u010div\u00fdch p\u0159\u00edpravk\u016f)<\/strong><\/p>\n\n\n\n

Vakc\u00edny Corona nevy\u017eaduj\u00ed ozna\u010den\u00ed<\/em><\/p>\n\n\n\n

\u00a711 AMG (p\u0159\u00edbalov\u00fd let\u00e1k)<\/strong><\/p>\n\n\n\n

Vakc\u00edny Corona nevy\u017eaduj\u00ed p\u0159\u00edbalovou informaci<\/em><\/p>\n\n\n\n

\u00a711a AMG (Informace pro zdravotnick\u00e9 pracovn\u00edky)<\/strong><\/p>\n\n\n\n

Vakc\u00edny Corona nevy\u017eaduj\u00ed souhrn \u00fadaj\u016f o p\u0159\u00edpravku<\/em><\/p>\n\n\n\n

\u00a721 AMG (po\u017eadavek na povolen\u00ed)<\/strong><\/p>\n\n\n\n

Vakc\u00edny Corona mohou b\u00fdt uvedeny na trh i bez povolen\u00ed.<\/em><\/p>\n\n\n\n

\u00a732 AMG (st\u00e1tn\u00ed zkou\u0161ka \u0161ar\u017ee)<\/strong><\/p>\n\n\n\n

Vakc\u00edny Corona mohou b\u00fdt uvedeny na trh i bez st\u00e1tn\u00edho testu \u0161ar\u017ee.<\/em><\/p>\n\n\n\n

\u00a743 AMG (povinnost l\u00e9k\u00e1rny)<\/strong><\/p>\n\n\n\n

Vakc\u00edny Corona mohou b\u00fdt uv\u00e1d\u011bny na trh obch\u00e1zen\u00edm l\u00e9k\u00e1ren.<\/em><\/p>\n\n\n\n

\u00a747 AMG (distribu\u010dn\u00ed kan\u00e1ly)<\/strong><\/p>\n\n\n\n

Vakc\u00edny Corona mohou b\u00fdt uvedeny na trh obejit\u00edm distribu\u010dn\u00edch kan\u00e1l\u016f (velkoobchod - l\u00e9k\u00e1rna - l\u00e9ka\u0159 - pacient).<\/em><\/p>\n\n\n\n

\u00a7 72 odst. 1 a 4 AMG (dovozn\u00ed povolen\u00ed)<\/strong><\/p>\n\n\n\n

Vakc\u00edny Corona lze do N\u011bmecka dov\u00e1\u017eet bez dovozn\u00ed licence.<\/em><\/p>\n\n\n\n

\u00a7 72a odst. 1 AMG (dovozn\u00ed osv\u011bd\u010den\u00ed)<\/strong><\/p>\n\n\n\n

Vakc\u00edny Corona lze do N\u011bmecka dov\u00e1\u017eet bez osv\u011bd\u010den\u00ed.<\/em><\/p>\n\n\n\n

\u00a7 72b odst. 1 a 2 AMG (dovozn\u00ed povolen\u00ed pro tk\u00e1n\u011b)<\/strong><\/p>\n\n\n\n

Tk\u00e1n\u011b pou\u017e\u00edvan\u00e9 k l\u00e9\u010db\u011b nebo prevenci COVID-19 mohou b\u00fdt do N\u011bmecka dov\u00e1\u017eeny bez povolen\u00ed.<\/em><\/p>\n\n\n\n

\u00a7 72c odst. 1 AMG (jednor\u00e1zov\u00fd dovoz tk\u00e1n\u00ed)<\/strong><\/p>\n\n\n\n

Jednor\u00e1zov\u00fd dovoz tk\u00e1n\u00ed pro l\u00e9\u010dbu nebo prevenci COVID-19 m\u016f\u017ee b\u00fdt do N\u011bmecka dovezen bez povolen\u00ed.<\/em><\/p>\n\n\n\n

\u00a773a AMG (v\u00fdvoz)<\/strong><\/p>\n\n\n\n

V\u00fdvoz koronov\u00fdch vakc\u00edn z N\u011bmecka nevy\u017eaduje licenci.<\/em><\/p>\n\n\n\n

\u00a778 AMG (Ceny)<\/strong><\/p>\n\n\n\n

Ceny za koronov\u00e9 vakc\u00edny mohou b\u00fdt voln\u011b tvo\u0159eny.<\/em><\/p>\n\n\n\n

\u00a784 AMG (objektivn\u00ed odpov\u011bdnost)<\/strong><\/p>\n\n\n\n

L\u00e9ka\u0159i a l\u00e9k\u00e1rn\u00edci nejsou odpov\u011bdn\u00ed za pod\u00e1n\u00ed vakc\u00edn corona.<\/em><\/p>\n\n\n\n

\u00a794 AMG (kryc\u00ed ustanoven\u00ed)<\/strong><\/p>\n\n\n\n

V\u00fdrobci nenesou odpov\u011bdnost za uveden\u00ed sv\u00fdch koronov\u00fdch vakc\u00edn na trh.<\/em><\/p>\n\n\n\n

Na\u0159\u00edzen\u00ed o obchodu s l\u00e9\u010div\u00fdmi p\u0159\u00edpravky (AM-HandelsV)<\/strong><\/p>\n\n\n\n

\u00a7 4a odst. 1 AM-HandelsV (v\u00fddej pouze autorizovan\u00fdmi spole\u010dnostmi)<\/strong><\/p>\n\n\n\n

Vakc\u00edny Corona mohou b\u00fdt poskytnuty komukoli.<\/em><\/p>\n\n\n\n

\u00a7 6 odst. 1 AM-HandelsV (doru\u010den\u00ed pouze spole\u010dnostem s licenc\u00ed)<\/strong><\/p>\n\n\n\n

Vakc\u00edny Corona mohou b\u00fdt poskytnuty komukoli.<\/em><\/p>\n\n\n\n

Byly p\u0159ijaty tyto z\u00e1kony a na\u0159\u00edzen\u00ed <\/strong>\u00a74 MedBVSV<\/u><\/strong><\/a> pro koronov\u00e9 vakc\u00edny byla pozastavena:<\/strong><\/p>\n\n\n\n

N\u011bmeck\u00fd z\u00e1kon o l\u00e9\u010div\u00fdch p\u0159\u00edpravc\u00edch (AMG)<\/strong><\/p>\n\n\n\n

\u00a713 AMG (povolen\u00ed k v\u00fdrob\u011b)<\/strong><\/p>\n\n\n\n

Vakc\u00edny Corona lze se souhlasem \u00fa\u0159ad\u016f vyr\u00e1b\u011bt i bez povolen\u00ed k v\u00fdrob\u011b.<\/em><\/p>\n\n\n\n

\u00a715 AMG (Odbornost)<\/strong><\/p>\n\n\n\n

Vakc\u00edny Corona lze se souhlasem \u00fa\u0159ad\u016f vyr\u00e1b\u011bt i bez odborn\u00fdch znalost\u00ed.<\/em><\/p>\n\n\n\n

\u00a719 AMG (oblasti odpov\u011bdnosti)<\/strong><\/p>\n\n\n\n

Vakc\u00edny Corona lze se souhlasem \u00fa\u0159ad\u016f vyr\u00e1b\u011bt i bez kvalifikovan\u00e9 osoby.<\/em><\/p>\n\n\n\n

Vyhl\u00e1\u0161ka o v\u00fdrob\u011b l\u00e9\u010div\u00fdch p\u0159\u00edpravk\u016f a aktivn\u00edch farmaceutick\u00fdch ingredienc\u00ed (AMWHV)<\/strong><\/p>\n\n\n\n

\u00a73 AMWHV (syst\u00e9m \u0159\u00edzen\u00ed kvality, spr\u00e1vn\u00e1 v\u00fdrobn\u00ed praxe a spr\u00e1vn\u00e1 odborn\u00e1 praxe)<\/strong><\/p>\n\n\n\n

Vakc\u00edny Corona mohou b\u00fdt se souhlasem \u00fa\u0159ad\u016f vyr\u00e1b\u011bny tak\u00e9 v rozporu s QMS, GMP a GfP.<\/em><\/p>\n\n\n\n

\u00a74 AMWHV (Person\u00e1l)<\/strong><\/p>\n\n\n\n

Vakc\u00edny Corona lze vyr\u00e1b\u011bt i bez dostate\u010dn\u011b kompetentn\u00edho a kvalifikovan\u00e9ho person\u00e1lu se souhlasem \u00fa\u0159ad\u016f.<\/em><\/p>\n\n\n\n

\u00a711 AMWHV (vlastn\u00ed kontrola a kvalifikace dodavatele)<\/strong><\/p>\n\n\n\n

Vakc\u00edny Corona lze se souhlasem \u00fa\u0159ad\u016f vyr\u00e1b\u011bt i bez pravideln\u00fdch vlastn\u00edch kontrol a kvalifikace dodavatel\u016f surovin, obalov\u00fdch materi\u00e1l\u016f apod.<\/em><\/p>\n\n\n\n

\u00a715 AMWHV (ozna\u010dov\u00e1n\u00ed)<\/strong><\/p>\n\n\n\n

Vakc\u00edny Corona lze se souhlasem \u00fa\u0159ad\u016f vyr\u00e1b\u011bt i bez ozna\u010den\u00ed.<\/em><\/p>\n\n\n\n

\u00a716 AMWHV (uvoln\u011bn\u00ed)<\/strong><\/p>\n\n\n\n

Vakc\u00edny Corona lze se souhlasem \u00fa\u0159ad\u016f uv\u00e1d\u011bt na trh i bez kvalitativn\u00edho testov\u00e1n\u00ed a schvalov\u00e1n\u00ed.<\/em><\/p>\n\n\n\n

\u00a717 AMWHV (Uv\u00e1d\u011bn\u00ed na trh a dovoz)<\/strong><\/p>\n\n\n\n

Vakc\u00edny Corona lze uv\u00e1d\u011bt na trh i bez povolen\u00ed a dov\u00e1\u017eet je ze zahrani\u010d\u00ed se souhlasem \u00fa\u0159ad\u016f.<\/em><\/p>\n\n\n\n

\u00a7 22 - 26 AMWHV (v\u00fdroba, zkou\u0161en\u00ed, ozna\u010dov\u00e1n\u00ed, uvol\u0148ov\u00e1n\u00ed a uv\u00e1d\u011bn\u00ed na trh, uv\u00e1d\u011bn\u00ed na trh a dovoz)<\/strong><\/p>\n\n\n\n

V p\u0159\u00edpad\u011b vakc\u00edn corona jsou v\u0161echny v\u00fd\u0161e uveden\u00e9 p\u0159edpisy se souhlasem \u00fa\u0159adu zru\u0161eny.<\/em><\/p>\n\n\n\n

V souladu s \u00a7 5 z\u00e1kona MedBVSV byla pozastavena platnost n\u00e1sleduj\u00edc\u00edch z\u00e1kon\u016f a p\u0159edpis\u016f pro vakc\u00edny Corona:<\/strong><\/p>\n\n\n\n

Z\u00e1kon o transf\u00fazi (TFG)<\/strong><\/p>\n\n\n\n

\u00a74 a \u00a77 ZPF (po\u017eadavek na organizaci poskytuj\u00edc\u00ed dar \/ po\u017eadavky na odvol\u00e1n\u00ed daru)<\/strong><\/p>\n\n\n\n

Lid\u00e9, kte\u0159\u00ed byli o\u010dkov\u00e1ni vakc\u00ednou proti koron\u00e1rn\u00ed infekci, mohou darovat krev.<\/em><\/p>\n\n\n\n

\u00a7 5 odst. 1 v\u011bta druh\u00e1 ZPF (v\u00fdb\u011br d\u00e1rc\u016f)<\/strong><\/p>\n\n\n\n

Lid\u00e9, kte\u0159\u00ed byli o\u010dkov\u00e1ni vakc\u00ednou proti koron\u00e1rn\u00ed infekci, mohou darovat krev.<\/em><\/p>\n\n\n\n

Kliknut\u00edm sem p\u0159ejdete p\u0159\u00edmo na v\u00fd\u0161e uveden\u00e9 z\u00e1kony a p\u0159edpisy:<\/p>\n\n\n\n

Z\u00e1kon o l\u00e9\u010div\u00fdch p\u0159\u00edpravc\u00edch<\/u><\/a><\/p>\n\n\n\n

Z\u00e1kon o transf\u00fazi<\/u><\/a><\/p>\n\n\n\n

Vyhl\u00e1\u0161ka o v\u00fdrob\u011b l\u00e9\u010div\u00fdch p\u0159\u00edpravk\u016f a aktivn\u00edch farmaceutick\u00fdch ingredienc\u00ed (AMWHV)<\/u><\/a><\/p>\n\n\n\n

Na\u0159\u00edzen\u00ed o zaji\u0161t\u011bn\u00ed z\u00e1sobov\u00e1n\u00ed zdravotnick\u00fdch pot\u0159eb (MedBVSV)<\/u><\/a><\/p>","protected":false},"excerpt":{"rendered":"

Doba \u010dten\u00ed<\/span> 3<\/span> minuty<\/span><\/span>Verordnung Medizinischer Bedarf Versorgungssicherstellungsverordnung (MedBVSV) ze dne 26.05.2020 Naposledy zm\u011bn\u011bno \u010dl. 1 V ze dne 9.3.2022 BAnz AT 10.03.2022 V1 V souladu s \u00a7 3 odst. 1 MedBVSV byly zru\u0161eny n\u00e1sleduj\u00edc\u00ed z\u00e1kony a vyhl\u00e1\u0161ky pro vakc\u00edny proti korun\u011b: \u00a7 8 odst. 3, \u00a7 10, 11, 11a a 21 odst. 1, \u00a7 21a odst. 1 a 9, \u00a7... \u010c\u00edst d\u00e1le \"Vyhl\u00e1\u0161ka pozastavuje platnost z\u00e1kon\u016f a p\u0159edpis\u016f pro vakc\u00edny proti koronavir\u016fm<\/span><\/a><\/p>","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_lmt_disableupdate":"","_lmt_disable":"","neve_meta_sidebar":"","neve_meta_container":"","neve_meta_enable_content_width":"","neve_meta_content_width":0,"neve_meta_title_alignment":"","neve_meta_author_avatar":"","neve_post_elements_order":"","neve_meta_disable_header":"","neve_meta_disable_footer":"","neve_meta_disable_title":"","footnotes":""},"categories":[628],"tags":[],"class_list":["post-2223","post","type-post","status-publish","format-standard","hentry","category-corona"],"modified_by":"Achim Goerner","_links":{"self":[{"href":"https:\/\/csiag.eu\/cs\/wp-json\/wp\/v2\/posts\/2223","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/csiag.eu\/cs\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/csiag.eu\/cs\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/csiag.eu\/cs\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/csiag.eu\/cs\/wp-json\/wp\/v2\/comments?post=2223"}],"version-history":[{"count":0,"href":"https:\/\/csiag.eu\/cs\/wp-json\/wp\/v2\/posts\/2223\/revisions"}],"wp:attachment":[{"href":"https:\/\/csiag.eu\/cs\/wp-json\/wp\/v2\/media?parent=2223"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/csiag.eu\/cs\/wp-json\/wp\/v2\/categories?post=2223"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/csiag.eu\/cs\/wp-json\/wp\/v2\/tags?post=2223"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}