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PREDBEŽNÁ INFORMÁCIA - Pripravovaný právny predpis


 | 21.8.2017 | komentárov: 385

Návrh opatrenia Ministerstva zdravotníctva Slovenskej republiky, ktorým sa dopĺňa opatrenie Ministerstva zdravotníctva Slovenskej republiky z 2. januára 2016 č. S06601-OL-2015 o požiadavkách na sledovanie krvi, zložiek z krvi a transfúznych liekov, na formu a spôsob oznamovania závažných nežiaducich reakcií a závažných nežiaducich udalostí a na vyhodnocovanie ich príčin a na normy a špecifikácie súvisiace so systémom kvality v transfuziologických zariadeniach

Obrazok

Základné ciele právnej úpravy

Cieľom návrhu opatrenia je prebrať smernicu Komisie (EÚ) 2016/11214 z  25. júla 2016, ktorou sa mení smernica 2005/62/ES, pokiaľ ide o normy a špecifikácie systému kvality v transfúznych zariadeniach (Ú. v. EÚ L 199, 26. 7. 2016, s. 14 a 15).

Vláda Slovenskej republiky uznesením č. 405 z 21. septembra 2016 uložila v bode B 17 ministrovi zdravotníctva Slovenskej republiky zabezpečiť prebratie smernice Komisie (EÚ) č. 2016/1214, ktorou sa mení smernica 2005/62/ES, pokiaľ ide o normy a špecifikácie systému kvality v transfúznych zariadeniach do  30. septembra 2017.

Ministerstvo zdravotníctva Slovenskej republiky preberie v určenom termíne smernicu opatrením Ministerstva zdravotníctva Slovenskej republiky, ktorým sa dopĺňa opatrenia Ministerstva zdravotníctva Slovenskej republiky  č. 1/2016 Z. z. č. S06601-OL-2015 o požiadavkách na sledovanie krvi, zložiek z krvi a transfúznych liekov, na formu a spôsob oznamovania závažných nežiaducich reakcií a závažných nežiaducich udalostí a na vyhodnocovanie ich príčin a na normy a špecifikácie súvisiace so systémom kvality v transfuziologických zariadeniach.

Zhodnotenie súčasného stavu

Doteraz platná smernica  požaduje, aby Komisia vypracovala usmernenia  pre správnu prax pri príprave transfúznych liekov. Dlhodobo sa touto témou zaoberá aj Rada Európy. Po dohode medzi Európskou úniou a Radou Európy bola vypracovaná Príručka pre prípravu, využívanie a zabezpečenie kvality zložiek z krvi (Guide to the preparation, use and quality assurance of blood components). Táto príručka je prílohou k odporúčaniu Výboru ministrov Rady Európy č. R (95) 15 o príprave, využívaní a zabezpečovaní kvality zložiek z krvi zo dňa 12. októbra 1995 Cieľom preberanej smernice je zabezpečiť používanie spomenutej príručky vo všetkých transfuziologických zariadeniach na území Európskej únie vrátane Slovenska.


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