Slovakia: Life Sciences Newsletter - Slovenská Republika

Last Updated: 22 February 2019
Article by Zuzana SimekovA and Ján Dulovič

Spoločnosti podnikajúce v oblasti life sciences pravidelne čelia novým výzvam súvisiacimi s aktuálnymi zmenami legislatívy. Pripravili sme pre Vás stručný prehľad vybraných právnych, regulačných a mediálnych noviniek za posledný kalendárny mesiac z oblasti life sciences prijatých v Slovenskej republike a v Európskej únii. Ku ka~dému príspevku je pripojený link, ktorý Vás presmeruje k podrobnejaím informáciám.

Právne novinky

Slovenská Republika

Zákon č. 374/2018 Z. z., ktorým sa mení a dopĺňa zákon č. 153/2013 Z. z. o národnom zdravotníckom informačnom systéme

Novela prináaa o.i. úpravu re~imu prístupu zdravotníckych pracovníkov k zdravotným údajom v elektronickej zdravotnej kni~ke, zmenu spôsobu zapisovania a rozsahu zapisovaných údajov do pacientskeho sumára, zmenu v procese vydávania elektronických preukazov zdravotníckeho pracovníka, atď. Bola prijatá taktie~ nová úprava vedenia zdravotnej dokumentácie v elektronickej podobe.

S účinnosťou od 1. januára 2019 doalo aj k nepriamej novelizácii zákona č. 363/2011 o rozsahu o rozsahu a podmienkach úhrady liekov, zdravotníckych pomôcok a dietetických potravín na základe verejného zdravotného poistenia a o zmene a doplnení niektorých zákonov (Zákon) v zmysle ktorej doalo k zmene zákonných podmienok pre zaradenia liekov určených na liečbu zriedkavých chorôb (tzv. orphan medicine) do zoznamu kategorizovaných liekov. 

Po novom tak do zoznamu kategorizovaných liekov mô~e byť zaradený len taký liek, ktorý je určený na liečbu choroby, ktorej prevalencia v Slovenskej republike je ni~aia ako 1:50 000 a liek nemá významný vplyv na prostriedky verejného zdravotného poistenia, oproti zneniu platnému do 31. decembra 2018, kedy sa uvedený pomer výskytu choroby viazal k počtu pacientov vhodných na liečbu liekov podľa registrovanej indikácie lieku. Ak liek uvedené nové kritérium nebude spĺňať, je potrebné v ~iadosti o kategorizáciu predlo~iť aj farmako-ekonomický rozbor. Keď~e vaak predmetná novela neobsahuje prechodné ustanovenia k Zákonu, uvedená zmena posudzovacieho kritéria sa bude vzťahovať aj na konania začaté pred 1. januárom 2019, ak sa o nich bude rozhodovať a~ po tomto dátume.

Zdroj: slov-lex.sk

Zákon č. 351/2018 Z. z. ktorým sa okrem iného mení a dopĺňa aj zákon č. 580/2004 Z. z. o zdravotnom poistení a o zmene a doplnení zákona č. 95/2002 Z. z. o poisťovníctve a o zmene a doplnení niektorých zákonov

Cieľom novely bolo zabezpečiť, aby vymáhanie pohľadávok na poistnom sa v prvom stupni realizovalo výlučne prostredníctvom zdravotných poisťovní. Doalo k zruaeniu mo~nosti vydania platobného výmeru Úradom pre dohľad nad zdravotnou starostlivosťou. Úlohy druhostupňového (odvolacieho) orgánu v plnej miere prevzal Úrad.

Zdroj: slov-lex.sk

Návrh zákona, ktorým sa mení a dopĺňa zákon č. 578/2004 Z. z. o poskytovateľoch zdravotnej starostlivosti, zdravotníckych pracovníkoch, stavovských organizáciách v zdravotníctve a o zmene a doplnení niektorých zákonov v znení neskoraích predpisov a ktorým sa menia a dopĺňajú niektoré zákony

Cieľom predlo~eného návrhu právnej úpravy je zriadenie nového typu ambulancie záchrannej zdravotnej slu~by, ktorá bude určená najmä na neodkladnú prepravu pacientov medzi zdravotníckymi zariadeniami. Zároveň sa navrhuje zriadenie nového typu zdravotníckeho zariadenia, a to ambulancie dopravnej zdravotnej slu~by, ktorá bude určená najmä na prepravu osoby do zdravotníckeho zariadenia alebo medzi zdravotníckymi zariadeniami alebo po poskytnutí zdravotnej starostlivosti zo zdravotníckeho zariadenia. Dátum konca MPK: 7. februára 2019. V súčasnosti prebieha vyhodnotenie medzirezortného pripomienkového konania.

Zdroj: slov-lex.sk

EURÓPSKA ÚNIA

NARIADENIE EURÓPSKEHO PARLAMENTU A RADY (EÚ) 2019/5 z 11. decembra 2018, ktorým sa mení nariadenie (ES) č. 726/2004, ktorým sa stanovujú postupy Spoločenstva pri povoľovaní liekov na humánne pou~itie a na veterinárne pou~itie a pri vykonávaní dozoru nad týmito liekmi a ktorým sa zriaďuje Európska agentúra pre lieky, nariadenie (ES) č. 1901/2006 o liekoch na pediatrické pou~itie a smernica 2001/83/ES, ktorou sa ustanovuje zákonník Spoločenstva o humánnych liekoch

Cieľom Komisie v predlo~enom návrhu na zmenu nariadenia č. 726/2004 je: (i) vypustiť z nariadenia (ES) č. 726/2004 ustanovenia týkajúce sa udeľovania a zachovávania povolení  

na uvedenie liekov na veterinárne pou~itie na trh a presunúť ich do nového  nariadenia; (ii) stanoviť určité zásady týkajúce sa poplatkov splatných Európskej agentúre, pričom sa zohľadňuje apecifická situácia malých a stredných podnikov; a (iii) zosúladiť nariadenie (ES) č. 726/2004 s Lisabonskou zmluvou. 

Zdroj: eur-lex.europa.eu

Regulačné novinky

Slovenská Republika

Zoznam liekov s úradne určenou cenou 1.3.2019 – 31.3.2019 – INFORMATÍVNY MATERIÁL 

Zdroj: health.gov.sk

Zoznam kategorizovaných liekov 1.3.2019 – 31.3.2019 – INFORMATÍVNY MATERIÁL

Zdroj: health.gov.sk

Brexit a Slovensko

Metodický pokyn Ministerstva zdravotníctva Slovenskej republiky k ~iadostiam o uznanie odbornej spôsobilosti pre občanov Slovenskej republiky, ktorí získali odbornú kvalifikáciu lekára, zubného lekára, farmaceuta, pôrodnej asistentky a sestry zodpovednej za vaeobecnú starostlivosť v Spojenom kráľovstve Veľkej Británie a Severného Írska, ak plánujú takúto činnosť vykonávať na území SR.

Zdroj: health.gov.sk

Aktualizácia informácií o bezpečnostných prvkoch

Dňa 9.2.2019 nadobudlo účinnosť Delegované nariadenie Komisie (EÚ) 2016/161, preto `tátny ústav pre kontrolu liečiv zverejnil aktualizované informácie o systéme overovania liekov. Nariadenie ukladá vaetkým stranám liekového reťazca povinnosť overovať pravosť liekov prostredníctvom takzvaných bezpečnostných prvkov. Nový verifikačný systém sa zavádza v celej Európskej únii. Jeho cieľom je zamedziť prenikaniu falaovaných liekov do legálneho reťazca a prispieť tak k bezpečnosti liekov a ochrane verejného zdravia.

Zdroj: sukl.sk

Výzva pre dr~iteľov rozhodnutia o registrácii na implementáciu časti 17 a 18 u liekov, ktoré musia byť vybavené bezpečnostnými prvkami

S ohľadom na termín začiatku uplatňovania Delegovaného nariadenia Komisie (EÚ) 2016/161 (týkajúce sa bezpečnostných prvkov) bola vydaná výzva pre dr~iteľov rozhodnutia o registrácii liekov, ktorí eate nepodali regulačnú zmenu na aktualizáciu textov o bezpečnostné prvky (časť 17 a 18 v označení obalu, napr. prostredníctvom oznámenia o zmene podľa §55(5) zákona č. 362/2011 Z.z.), k podaniu prísluanej regulačnej zmeny.

Zdroj: sukl.sk

Stiahnutie lieku OLYNTH HA 0,1% z trhu

Zdroj: sukl.sk

Stiahnutie lieku Irbesartan Actavis z trhu

Zdroj: sukl.sk

Európska Únia

Humánne lieky: highlights of 2018

Zdroj: ema.europa.eu

Európska agentúra pre lieky (EMA) vydala revidované znenie jej usmernenia týkajúceho liečenia bakteriálnych infekcií, ktorým sa má posilniť globálny prístup k vývoju nových antibakteriálnych liekov

Zdroj: ema.europa.eu

Mediálne novinky

Nový verifikačný systém overovania liekov odatartuje 9. februára

Nový systém, ktorý bude overovať pravosť liekov prostredníctvom tzv. bezpečnostných prvkov, by mal fungovať od 9. februára. Informuje o tom `tátny ústav pre kontrolu liečiv (`ÚKL) na svojom webe.

Zdroj: mediweb.hnonline.sk

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