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Európska agentúra pre lieky (EMA)


 | 12.8.2017 | komentárov: 394

Európska agentúra pre lieky (ďalej ako EMA alebo Agentúra) je decentralizovaná agentúra Európskej únie zodpovedná za vedecké hodnotenie, dohľad a monitorovanie bezpečnosti liekov v EÚ.

Obrazok

EMA patrí medzi agentúry, ktoré boli zriadené za účelom plnenia veľmi špecifických, technických a predovšetkým vedeckých úloh v rámci spoločnej zahraničnej a bezpečnostnej politiky Európskej únie.  V prípade agentúry EMA jej základná úloha spočíva v podpore rozvoja liekov a zabezpečenia ich včasného prístupu k pacientom v rámci európskeho priestoru.

Európska agentúra pre lieky v súčasnosti sídli v Londýne. Na čele agentúry EMA stojí 36-členná správna rada, ktorej členovia konajú vo verejnom záujme a nezastupujú žiadnu vládnu organizáciu ani odvetvie. Správna rada určuje rozpočet agentúry a schvaľuje jej ročný pracovný program. Zároveň zodpovedá za to, aby agentúra fungovala efektívne a úspešne spolupracovala s partnerskými organizáciami v celej EÚ aj mimo nej. Spolu so správnou radou na čele agentúry stojí výkonný riaditeľ, ktorý zodpovedá za všetky prevádzkové záležitosti, personálne otázky a prípravu ročného pracovného programu.

Súčasť vnútornej organizácie agentúry popri vyššie uvedených orgánoch, predstavujú vedecké výbory, ktoré hodnotia lieky pozdĺž ich životného cyklu od počiatočných štádií vývoja, ako je udelenie povolenia uvedenia lieku na trh až po užitie lieku konečným užívateľom.  Výbory pozostávajú z európskych expertov v danej oblasti, ktorý úzko spolupracujú s orgánmi členských štátov, ale aj orgánmi Európskej únie. Okrem toho má agentúra niekoľko pracovných skupín a súvisiacich skupín, ktoré výborom pomáhajú posudzovať jednotlivé vedecké otázky a s ktorými môžu výbory konzultovať problémy týkajúce sa konkrétnej oblasti.

V súčasnosti EMA zohráva dôležitú  úlohu pri podpore výskumu a inovácií vo farmaceutickom sektore a podporuje inovácie a vývoj nových liekov európskymi mikropodnikmi, malými a strednými podnikmi. Dôležitú úlohu zohráva predovšetkým pri vyhodnocovaní žiadosti o povolenie lieku na uvedenie na trh, kedy vedecké výbory EMA poskytujú nezávislé odporúčania týkajúce sa liekov na humánne a veterinárne použitie založené na komplexnom vedeckom hodnotení údajovEMA zároveň koordinuje inšpekcie , ktoré vykonávajú kontrolu v súvislosti s udelením povolenia a monitorujte bezpečnosť liekov počas ich životného cyklu. Medzi ďalšie úlohy Agentúry patrí tiež poskytovať informácie zdravotným pracovníkom a pacientom. Úloha spočíva v zverejňovaní jasných a nestranných informáciách o liekoch a ich schválenom použití.

Dňa 29. marca 2017 oznámilo Spojené kráľovstvo Európskej rade svoj úmysel odstúpiť z Európskej únie, proces známi ako "Brexit". Nakoľko Spojené kráľovstvo už nebude súčasťou Európskej únie, Agentúra EMA bude musieť svoje sídlo presťahovať do jedného zo štátov Európskej únie. Agentúra EMA sa na presídlenie pripravuje už dlhšiu dobu, aby mohla naďalej plniť svoje poslanie a chrániť zdravie ľudí a zvierat po tom, ako Spojené kráľovstvo opustí EÚ 30. marca 2019, čo je dátum, ktorý je v súčasnosti stanovený časovým rámcom stanoveným v článku 50 Zmluvy o Európskej únii.  Aktuálna situácia súvisiaca s presťahovaním agentúry predstavuje akýsi precedens, keďže doposiaľ  žiadny členský štát nevystúpil z EÚ, preto bude veľmi dôležité ako bude EÚ postupovať.


Zdroj: https://europa.eu/european-union/about-eu/agencies/ema_sk




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