[{"@context":"https:\/\/schema.org\/","@type":"Article","@id":"https:\/\/www.tizon.cz\/registrace-leciv-golias-ktery-neni-videt\/#Article","mainEntityOfPage":"https:\/\/www.tizon.cz\/registrace-leciv-golias-ktery-neni-videt\/","headline":"Registrace l\u00e9\u010div – goli\u00e1\u0161, kter\u00fd nen\u00ed vid\u011bt","name":"Registrace l\u00e9\u010div – goli\u00e1\u0161, kter\u00fd nen\u00ed vid\u011bt","description":"L\u00e9ky, p\u0159esn\u011bji \u0159e\u010deno l\u00e9\u010div\u00e9 p\u0159\u00edpravky, se staly b\u011b\u017enou sou\u010d\u00e1st\u00ed na\u0161ich \u017eivot\u016f. M\u00e1me k dispozici l\u00e9ky na nejr\u016fzn\u011bj\u0161\u00ed onemocn\u011bn\u00ed, l\u00e9ky na vz\u00e1cn\u00e9 choroby, vakc\u00edny, to v\u0161e v rozmanit\u00e9 \u0161k\u00e1le l\u00e9kov\u00fdch forem a balen\u00ed. M\u00e1lokdo si ale uv\u011bdomuje, jakou cestu tyto l\u00e9\u010div\u00e9 p\u0159\u00edpravky musely urazit, ne\u017e se mohly objevit v na\u0161ich ruk\u00e1ch. L\u00e9\u010div\u00e9 p\u0159\u00edpravky ozna\u010dovan\u00e9 jako hromadn\u011b […]","datePublished":"2021-09-03","dateModified":"2021-09-03","author":{"@type":"Person","@id":"https:\/\/www.tizon.cz\/author\/#Person","name":"","url":"https:\/\/www.tizon.cz\/author\/","identifier":1,"image":{"@type":"ImageObject","@id":"https:\/\/secure.gravatar.com\/avatar\/91506ed60e31abe586276a3e1420719df081581a820344a28fa2034bb1a2fe22?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/91506ed60e31abe586276a3e1420719df081581a820344a28fa2034bb1a2fe22?s=96&d=mm&r=g","height":96,"width":96}},"publisher":{"@type":"Organization","name":"tizon.cz","logo":{"@type":"ImageObject","@id":"\/logo.png","url":"\/logo.png","width":600,"height":60}},"image":{"@type":"ImageObject","@id":"https:\/\/www.tizon.cz\/wp-content\/uploads\/papers-g6c2e8f057_640.jpg","url":"https:\/\/www.tizon.cz\/wp-content\/uploads\/papers-g6c2e8f057_640.jpg","height":0,"width":0},"url":"https:\/\/www.tizon.cz\/registrace-leciv-golias-ktery-neni-videt\/","about":["Nakupov\u00e1n\u00ed"],"wordCount":377,"articleBody":"   L\u00e9ky, p\u0159esn\u011bji \u0159e\u010deno l\u00e9\u010div\u00e9 p\u0159\u00edpravky, se staly b\u011b\u017enou sou\u010d\u00e1st\u00ed na\u0161ich \u017eivot\u016f. M\u00e1me k dispozici l\u00e9ky na nejr\u016fzn\u011bj\u0161\u00ed onemocn\u011bn\u00ed, l\u00e9ky na vz\u00e1cn\u00e9 choroby, vakc\u00edny, to v\u0161e v rozmanit\u00e9 \u0161k\u00e1le l\u00e9kov\u00fdch forem a balen\u00ed. M\u00e1lokdo si ale uv\u011bdomuje, jakou cestu tyto l\u00e9\u010div\u00e9 p\u0159\u00edpravky musely urazit, ne\u017e se mohly objevit v na\u0161ich ruk\u00e1ch. L\u00e9\u010div\u00e9 p\u0159\u00edpravky ozna\u010dovan\u00e9 jako hromadn\u011b vyr\u00e1b\u011bn\u00e9 l\u00e9\u010div\u00e9 p\u0159\u00edpravky, toti\u017e musely proj\u00edt procesem registrace. Jedn\u00e1 se o soubor \u010dinnost\u00ed a posudk\u016f na jejich\u017e konci vyd\u00e1 p\u0159\u00edslu\u0161n\u00e1 instituce rozhodnut\u00ed o registraci. V \u010cesk\u00e9 republice je touto instituc\u00ed St\u00e1tn\u00ed \u00fastav pro kontrolu l\u00e9\u010div (S\u00daKL). Mnohem \u010dast\u011bji v\u0161ak registrace podl\u00e9haj\u00ed hierarchicky v\u00fdznamn\u011bj\u0161\u00ed Evropsk\u00e9 l\u00e9kov\u00e9 agentu\u0159e (EMA). Co vlastn\u011b proces registrace p\u0159edstavuje a pro\u010d je vy\u017eadov\u00e1n? Registra\u010dn\u00ed proces slou\u017e\u00ed ke sn\u00ed\u017een\u00ed potenci\u00e1ln\u00edch rizik l\u00e9\u010diva pro pacienty po jeho uveden\u00ed na trh. Soulad p\u0159\u00edslu\u0161n\u00e9 dokumentace s nejmodern\u011bj\u0161\u00edmi v\u011bdeck\u00fdmi poznatky a legislativn\u00edmi po\u017eadavky tak zaru\u010duje uveden\u00ed kvalitn\u00edho, \u00fa\u010dinn\u00e9ho a bezpe\u010dn\u00e9ho l\u00e9\u010diva. Pr\u00e1v\u011b kvalita, \u00fa\u010dinnost a bezpe\u010dnost jsou hlavn\u00edmi prioritami tohoto procesu. D\u00e1le jsou posuzov\u00e1ny tak\u00e9 informace t\u00fdkaj\u00edc\u00ed se indikace, kontraindikace, d\u00e1vkov\u00e1n\u00ed a v neposledn\u00ed \u0159ad\u011b i obsah p\u0159\u00edbalov\u00e9 informace a grafick\u00e1 str\u00e1nka obalu p\u0159\u00edpravku. Proces registrace l\u00e9\u010div ale vyd\u00e1n\u00edm rozhodnut\u00ed nekon\u010d\u00ed. Dr\u017eitel rozhodnut\u00ed o registraci, \u010dili spole\u010dnost, kter\u00e1 obdr\u017eela rozhodnut\u00ed o registraci k dan\u00e9mu l\u00e9\u010div\u00e9mu p\u0159\u00edpravku se z\u00e1rove\u0148 zavazuje k n\u00e1sledn\u00e9mu dohledu nad t\u00edmto l\u00e9\u010div\u00fdm p\u0159\u00edpravkem a aktualizaci informac\u00ed podle nejnov\u011bj\u0161\u00edch poznatk\u016f v\u011bdy. Tyto zm\u011bny pak op\u011bt ponech\u00e1v\u00e1 k posouzen\u00ed S\u00daKL v r\u00e1mci tzv. poregistra\u010dn\u00edho sledov\u00e1n\u00ed. Do rukou se n\u00e1m d\u00edky tomu dost\u00e1vaj\u00ed pouze l\u00e9\u010diva pat\u0159i\u010dn\u00e9 kvality, kter\u00e1 si kladou za c\u00edl p\u0159in\u00e1\u0161et sv\u00fdm u\u017eivatel\u016fm prosp\u011bch, a minimalizovat p\u0159\u00edpadn\u00e9 zdravotn\u00ed riziko.                                                                                                                                                                                                                                                                                                                                                                                                   "},{"@context":"https:\/\/schema.org\/","@type":"BreadcrumbList","itemListElement":[{"@type":"ListItem","position":1,"name":"Registrace l\u00e9\u010div – goli\u00e1\u0161, kter\u00fd nen\u00ed vid\u011bt","item":"https:\/\/www.tizon.cz\/registrace-leciv-golias-ktery-neni-videt\/#breadcrumbitem"}]}]