{"id":314549,"date":"2024-07-19T19:01:51","date_gmt":"2024-07-19T18:01:51","guid":{"rendered":"https:\/\/zakrasnejsivimperk.cz\/?p=314549"},"modified":"2024-07-19T19:01:51","modified_gmt":"2024-07-19T18:01:51","slug":"z-prvni-ruky-ministerstvo-zdravotnictvi-pro-zajisteni-leku-delame-maximum-vysledky-mame-na-ceske-i-evropske-urovni","status":"publish","type":"post","link":"https:\/\/zakrasnejsivimperk.cz\/?p=314549","title":{"rendered":"Z PRVN\u00cd RUKY: Ministerstvo zdravotnictv\u00ed: Pro zaji\u0161t\u011bn\u00ed l\u00e9k\u016f d\u011bl\u00e1me maximum. V\u00fdsledky m\u00e1me na \u010desk\u00e9 i evropsk\u00e9 \u00farovni"},"content":{"rendered":"
\"\"Prvn\u00edho \u010dervna vstoupila v \u00fa\u010dinnost z\u00e1sadn\u00ed \u010d\u00e1st z\u00e1kona o l\u00e9\u010divech. Nov\u00e9 povinnosti a n\u00e1stroje z\u00edskali dr\u017eitel\u00e9 rozhodnut\u00ed o registraci, distributo\u0159i, l\u00e9k\u00e1rny, Ministerstvo zdravotnictv\u00ed i St\u00e1tn\u00ed \u00fastav pro kontrolu l\u00e9\u010div. Resort zdravotnictv\u00ed d\u011bl\u00e1 pro zaji\u0161t\u011bn\u00ed dostupnosti l\u00e9k\u016f maximum, a to nejen na \u010desk\u00e9, ale tak\u00e9 evropsk\u00e9 \u00farovni. Na\u00a0dne\u0161n\u00edm setk\u00e1n\u00ed s novin\u00e1\u0159i to \u0159ekli z\u00e1stupci Ministerstva zdravotnictv\u00ed a S\u00daKLu.<\/b><\/h6>\n

Po prvn\u00edm \u010dervnu 2024 se v\u00fdrazn\u011b zv\u00fd\u0161ila ochrana pacient\u016f p\u0159ed dopady v\u00fdpadk\u016f dod\u00e1vek l\u00e9\u010div, informovanost v\u0161ech akt\u00e9r\u016f \u010desk\u00e9ho l\u00e9kov\u00e9ho trhu a zp\u0159\u00edsnila pravidla exportu l\u00e9\u010div do zahrani\u010d\u00ed. Kombinace povinnosti distributor\u016f dr\u017eet z\u00e1soby vybran\u00fdch l\u00e9\u010div a dr\u017eitel\u016f licence dod\u00e1vat l\u00e9\u010diva je\u0161t\u011b v obdob\u00ed po nahl\u00e1\u0161en\u00ed v\u00fdpadku tak\u00e9 povede k p\u0159eklenut\u00ed krat\u0161\u00edch v\u00fdpadk\u016f a poskytne \u010das pro \u0159e\u0161en\u00ed v\u00fdpadk\u016f dlouhodob\u011bj\u0161\u00edho charakteru.<\/p>\n

\u201eJde o nejv\u011bt\u0161\u00ed reformu l\u00e9kov\u00e9 legislativy za posledn\u00ed roky, nav\u00edc v\u00fdrazn\u011b propacientskou. Zvy\u0161uje odolnost \u010desk\u00e9ho l\u00e9kov\u00e9ho trhu proti v\u00fdpadk\u016fm a\u00a0minimalizuje jejich dopady na ob\u010dany. Prvn\u00ed data ukazuj\u00ed, \u017ee n\u00e1stroje jsou \u00fa\u010dinn\u00e9. I\u00a0nad\u00e1le jsme ale v kontaktu se v\u0161emi \u00fa\u010dastn\u00edky l\u00e9kov\u00e9ho trhu, aby n\u00e1stup nov\u00fdch n\u00e1stroj\u016f prob\u011bhl hladce,\u201d\u00a0<\/i>\u0159ekl ministr zdravotnictv\u00ed Vlastimil V\u00e1lek.<\/i><\/b><\/p>\n

Z\u00e1sadn\u00ed zm\u011bnou, kter\u00e1 vstoupila v \u00fa\u010dinnost je povinnost dr\u017eitele rozhodnut\u00ed o registraci zajistit pro pacienty v \u010cR dod\u00e1vky l\u00e9\u010div\u00e9ho p\u0159\u00edpravku, pro kter\u00fd ozn\u00e1mil p\u0159eru\u0161en\u00ed nebo ukon\u010den\u00ed uv\u00e1d\u011bn\u00ed na trh v \u010cR, v mno\u017estv\u00ed odpov\u00eddaj\u00edc\u00edm 1-2 pr\u016fm\u011brn\u00fdm m\u011bs\u00ed\u010dn\u00edm dod\u00e1vk\u00e1m (do konce roku 2024 jsou z d\u016fvodu p\u0159\u00edpravy syst\u00e9m\u016f a v\u00fdroby tyto dod\u00e1vky v polovi\u010dn\u00ed v\u00fd\u0161i), p\u0159\u00edpadn\u011b l\u00e9ku, kter\u00fd jej m\u016f\u017ee nahradit.<\/p>\n

Dal\u0161\u00ed zm\u011bnou je p\u0159\u00edznak \u201eomezen\u00e1 dostupnost\u201c, kter\u00fdm je St\u00e1tn\u00edm \u00fastavem pro kontrolu l\u00e9\u010div ozna\u010den l\u00e9\u010div\u00fd p\u0159\u00edpravek, u kter\u00e9ho S\u00daKL vyhodnotil, \u017ee jeho aktu\u00e1ln\u00ed mno\u017estv\u00ed dostate\u010dn\u011b nepokr\u00fdv\u00e1 pot\u0159eby pacient\u016f v \u010cesk\u00e9 republice a z\u00e1rove\u0148 tuto pot\u0159ebu nelze v odpov\u00eddaj\u00edc\u00edm mno\u017estv\u00ed nahradit jin\u00fdm s odpov\u00eddaj\u00edc\u00edmi l\u00e9\u010debn\u00fdmi vlastnostmi. U takov\u00e9ho l\u00e9ku t\u00edm z\u00e1rove\u0148 automaticky za\u010d\u00edn\u00e1 platit z\u00e1kaz distribuce do zahrani\u010d\u00ed. Vznik\u00e1 u nich tak\u00e9 povinnost l\u00e9k\u00e1ren a distributor\u016f hl\u00e1sit skladov\u00e9 z\u00e1soby a jejich objedn\u00e1v\u00e1n\u00ed l\u00e9k\u00e1rnami je regulov\u00e1no tak, aby tyto z\u00e1soby byly vyu\u017eity efektivn\u011b a dostupnost l\u00e9k\u016f byla zaji\u0161t\u011bna v maxim\u00e1ln\u00ed m\u00ed\u0159e na \u00fazem\u00ed \u010cesk\u00e9 republiky.<\/p>\n

\u201eZa \u010derven jsme vydali 18 opat\u0159en\u00ed obecn\u00e9 povahy t\u00fdkaj\u00edc\u00ed se l\u00e9\u010div\u00e9ho p\u0159\u00edpravku s\u00a0p\u0159\u00edznakem omezen\u00e1 dostupnost. Evidujeme tak\u00e9 des\u00edtky p\u0159\u00edpad\u016f nehl\u00e1\u0161en\u00ed dod\u00e1vek od dr\u017eitel\u016f rozhodnut\u00ed o registraci, kter\u00e9 aktu\u00e1ln\u011b \u0159e\u0161\u00edme. Z\u00e1rove\u0148 jsme v\u00a0pravideln\u00e9m kontaktu s odborn\u00fdmi spole\u010dnostmi a \u010ceskou l\u00e9k\u00e1rnickou komorou, jejich\u017e podn\u011bty se pr\u016fb\u011b\u017en\u011b zab\u00fdv\u00e1me,\u201d<\/i>\u00a0\u0159ekl \u0159editel St\u00e1tn\u00edho \u00fastavu pro kontrolu l\u00e9\u010div Tom\u00e1\u0161 Bor\u00e1\u0148.<\/p>\n

Ministerstvo zdravotnictv\u00ed \u010cR d\u011bl\u00e1 pro zaji\u0161t\u011bn\u00ed dostupnosti l\u00e9k\u016f maximum, a to i na evropsk\u00e9 \u00farovni. Na \u010dervnov\u00e9m jedn\u00e1n\u00ed Rady ministr\u016f zdravotnictv\u00ed EPSCO do\u0161lo k v\u00fdrazn\u011b podpo\u0159e iniciativy ministra zdravotnictv\u00ed Vlastimila V\u00e1lka proti nadm\u011brn\u00e9 tvorb\u011b z\u00e1sob l\u00e9\u010div na n\u00e1rodn\u00ed \u00farovni, kter\u00e9 by vedlo k ohro\u017een\u00ed dod\u00e1vek l\u00e9\u010div do jin\u00fdch \u010dlensk\u00fdch st\u00e1t\u016f. \u010ceskou iniciativu proti excesivn\u00edm n\u00e1rodn\u00edm z\u00e1sob\u00e1m l\u00e9k\u016f podpo\u0159ilo 19 \u010dlensk\u00fdch st\u00e1t\u016f Evropsk\u00e9 unie i Evropsk\u00e1 komise.<\/p>\n

\u201eJde o zcela z\u00e1sadn\u00ed krok k tomu, aby si jednotliv\u00e9 st\u00e1ty vz\u00e1jemn\u011b nezp\u016fsobovaly nedostatek l\u00e9\u010div. Pokra\u010dujeme v pr\u00e1ci, kter\u00e1 se re\u00e1ln\u011b prom\u00edtne v dal\u0161\u00edm d\u011bn\u00ed na\u00a0evropsk\u00e9 \u00farovni. To v\u0161e s jedn\u00edm c\u00edlem \u2013 aby byl po cel\u00e9 Evrop\u011b dostatek l\u00e9k\u016f. To\u00a0lze zajistit pouze spole\u010dn\u00fdmi \u0159e\u0161en\u00edmi, na kter\u00fdch Evropsk\u00e1 unie s na\u0161\u00ed aktivn\u00ed \u00fa\u010dast\u00ed pracuje,\u201d<\/i>uzav\u0159el n\u00e1m\u011bstek ministra zdravotnictv\u00ed Jakub Dvo\u0159\u00e1\u010dek.<\/p>\n

(tz-mz)<\/strong><\/p>\n

\n

 <\/p>\n

Dnes informujeme:<\/h6>\n

Kontroly hra\u010dek potvrdily nedostatky v povinn\u00e9m zna\u010den\u00ed a identifikaci v\u00fdrobce, bateriov\u00e9 hra\u010dky obsahuj\u00ed nadlimitn\u00ed mno\u017estv\u00ed olova v p\u00e1jen\u00fdch spoj\u00edch<\/a><\/h4>\n

Nejv\u00edce kontrol farm\u00e1\u0159sk\u00fdch trh\u016f se uskute\u010d\u0148uje v letn\u00edm obdob\u00ed<\/a><\/h4>\n

Obce v n\u00e1rodn\u00edch parc\u00edch mohou vym\u011bnit ve\u0159ejn\u00e9 osv\u011btlen\u00ed. Pom\u016f\u017ee jim dotace Ministerstva \u017eivotn\u00edho prost\u0159ed\u00ed<\/a><\/h4>\n

Replika starov\u011bk\u00e9 \u0159\u00edmsk\u00e9 lodi kotv\u00ed ode dne\u0161ka na Nov\u00fdch ml\u00fdnech<\/a><\/h4>\n

P\u0159i cestov\u00e1n\u00ed do zahrani\u010d\u00ed je o\u010dkov\u00e1n\u00ed d\u016fle\u017eitou ochranou p\u0159ed vybran\u00fdmi infekcemi<\/a><\/h4>\n
\n

 <\/p>\n","protected":false},"excerpt":{"rendered":"

Prvn\u00edho \u010dervna <\/p>\n","protected":false},"author":2,"featured_media":314550,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"gallery","meta":{"footnotes":""},"categories":[70],"tags":[],"jetpack_featured_media_url":"https:\/\/zakrasnejsivimperk.cz\/wp-content\/uploads\/2024\/07\/19\/z-ruky-leky.jpg","_links":{"self":[{"href":"https:\/\/zakrasnejsivimperk.cz\/index.php?rest_route=\/wp\/v2\/posts\/314549"}],"collection":[{"href":"https:\/\/zakrasnejsivimperk.cz\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/zakrasnejsivimperk.cz\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/zakrasnejsivimperk.cz\/index.php?rest_route=\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/zakrasnejsivimperk.cz\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=314549"}],"version-history":[{"count":2,"href":"https:\/\/zakrasnejsivimperk.cz\/index.php?rest_route=\/wp\/v2\/posts\/314549\/revisions"}],"predecessor-version":[{"id":314612,"href":"https:\/\/zakrasnejsivimperk.cz\/index.php?rest_route=\/wp\/v2\/posts\/314549\/revisions\/314612"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/zakrasnejsivimperk.cz\/index.php?rest_route=\/wp\/v2\/media\/314550"}],"wp:attachment":[{"href":"https:\/\/zakrasnejsivimperk.cz\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=314549"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zakrasnejsivimperk.cz\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=314549"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zakrasnejsivimperk.cz\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=314549"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}