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Aktuálne informácie z legislatívneho procesu EÚ


 | 14.9.2011 | komentárov: 436

Na našom portáli Vám podávame aktuálne informácie z legislatívneho procesu v SR, no záväzná resp. smerná legislatíva sa pripravuje aj v Európskych inštitúciách. Budeme sa Vám snažiť ponúkať aj výber európskej legislatívy, ktorá je v príprave. Toto je prvý príspevok na túto tému.

Obrazok

Návrh směrnice a nařízení Evropského parlamentu a Rady týkající se poskytování informací o léčivých přípravcích vázaných na předpis široké veřejnosti

Směrnice 2001/83/ES zakazuje reklamu zaměřenou na širokou veřejnost (tj. přímo na pacienty), jejímž předmětem jsou léčivé přípravky vázané na lékařský předpis. Na tuto skupinu léčivých přípravků je možné provádět pouze reklamu zaměřenou na odbornou veřejnost. Jediné typy informací, které v současné době může držitel registračního rozhodnutí poskytovat veřejnosti, jsou schválené texty souhrnu údajů o přípravku (SPC), příbalové informace (PIL) a označení na obalu (např. v ČR tyto informace poskytuje držitel registračního rozhodnutí v rámci veřejně přístupné odborné informační služby, kterou je držitel registrace povinen provozovat ze zákona).

Současná evropská legislativa jinak poskytování informací o léčivých přípravcích detailním způsobem neupravuje, proto se rozhodla Evropská komise toto změnit a předložila v prosinci 2008 také návrh změny uvedené směrnice.

Stav projednávání naleznete zde.

Analogicky ke změně směrnice 2001/83/ES navrhla Komise také změnu nařízení č. 726/2004, které upravuje podmínky pro léčivé přípravky registrované tzv. centralizovanou procedurou, neboť výše uvedené principy se vztahují také na informace o léčivých přípravcích vázaných na předpis registrovaných tímto způsobem.

Stav projednávání naleznete zde.
 
Návrh nařízení Evropského parlamentu a Rady o uvádění biocidních přípravků na trh a jejich používání

Stávající legislativní rámec k biocidní problematice neumožňuje efektivně řešit zařazování účinných látek do příloh směrnice 98/8/ES a to ani při využití zjednodušujících procedur týkajících se zejména látek s nízkým rizikem. Rovněž byla identifikována řada dalších nedostatků týkajících se např. povolování a registrací biocidních přípravků, které zatěžují průmysl náklady neúměrnými přínosu plynoucímu zejména ze zvýšené ochrany zdraví a životního prostředí. Negativní vliv na zavedení harmonizovaných podmínek pro uvádění biocidů na trh má v neposlední řadě nejednotný způsob transpozice směrnice a dohodnutých postupů do jednotlivých národních legislativ.

Předložený návrh nařízení upravující podmínky uvádění biocidních přípravků na trh řeší zmíněné problémy např. zjednodušením procedury povolování biocidů, posílením funkce vzájemného uznávání povolení biocidů, zavedením povinného sdílení údajů z testů prováděných na obratlovcích, zlepšením ochrany údajů a dalšími opatřeními. Sjednocení podmínek pro uvádění biocidů na trh v jednotlivých státech vyplývá ze skutečnosti, že se jedná o přímo použitelný předpis.

Stav projednávání naleznete zde.
 
Návrh nařízení Evropského parlamentu a Rady o potravinách určených pro kojence a malé děti a o potravinách pro zvláštní lékařské účely

Základní požadavky na potraviny pro zvláštní výživu jsou v současné době stanoveny kmenovou směrnicí Evropského parlamentu a Rady 2009/39/ES ze dne 6. května 2009 o potravinách určených pro zvláštní výživu. Za dobu 30 let platnosti tohoto právního předpisu již došlo ke značnému vývoji v oblasti potravinářského průmyslu a k rozvoji vědecko-technických poznatků, kdy tento rozvoj se dostal do určitých konfliktů se stávající právní úpravou. Proto bylo rozhodnuto přikročit k revizi stávající právní úpravy, a to na základě průzkumu mezi členskými státy, který měl identifikovat problémy a stanovit hlavní směry revize.

Předmětný návrh nařízení představuje zcela nový koncept v oblasti potravin pro zvláštní výživu, kdy se zrušuje definice „potravin pro zvláštní výživu“ a kromě kojenecké a pokračovací výživy, obilných příkrmů a potravin pro kojence a malé děti a potravin pro zvláštní lékařské účely se ruší všechny dosavadní kategorie potravin pro zvláštní výživu. U uvedených druhů potravin pak návrh předpokládá přijetí seznamu EU povolených vitaminů, minerálních a dalších látek, které budou moci být do těchto potravin přidávány, a dále stanoví další dodatečné požadavky na jejich složení a označování, kdy tato opatření by měla být přijata nejpozději do dvou let od vstupu v platnost tohoto nařízení.

Stav projednávání naleznete zde.
 
Návrh Směrnice Evropského parlamentu a Rady o minimálních požadavcích na bezpečnost a ochranu zdraví před expozicí zaměstnanců rizikům spojených s fyzikálními činiteli - elektromagnetickými poli

Cílem předkládaného návrhu je novelizovat směrnici Evropského parlamentu a Rady 2004/40/ES ze dne 29. dubna 2004, která byla po přijetí podrobena poměrně obsáhlé kritice skupin uživatelů pracujících se zařízeními magnetického rezonančního zobrazování.

Návrh nové směrnice v podstatné části vychází ze směrnice 2004/40/ES, avšak, jak již bylo zmíněno, bere v potaz připomínky odborné veřejnosti. Nová směrnice stanovuje  nejvyšší přípustné hodnoty expozice časově proměnným elektrickým, magnetickým a elektromagnetickým polím s kmitočty od 0 do 300 GHz. Zaměřuje se tedy i na vyšší frekvence záření (100kHz-300GHz), jelikož v současnosti nejsou k dispozici žádná mezinárodní doporučení zaměřující se na vysokofrekvenční záření.
Návrh nové směrnice také zavádí v oblasti expozice elektromagnetickým polím do 100 kHz tzv. „zónovací“ systém, stanovuje rozdíl mezi vystavením se záření o nízké frekvenci a vysoké frekvenci. Tato změna, stejně jako všechny ostatní, koresponduje s novými vědeckými poznatky.

Stav projednávání naleznete zde.



zdroj: Ministerstvo Zdravotníctva ČR, mzcz.cz, pôvodne tu.
foto: telegraph.co.uk




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