Nový symbol na liekoch | Medicínske právo
              

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Nový symbol na liekoch


 | 15.3.2013 | komentárov: 385

Symbol čierneho obráteného trojuholníka, ktorý sa objaví na letákoch liekov, bude podľa rozhodnutia Komisie (Európskej únie) označovať lieky, ktoré sú predmetom monitorovania.

Obrazok Príbalové balenie takýchto liekov bude od septembra 2013 oboznamovať pacientov, aby v prípadné nečakané nežiadúce  účinky nahlásili prostredníctvom vnútroštátnych oznamovacích systémov.

"Pacientom i zdravotníckemu personálu tento symbol pomôže získať obsiahlejšie a kvalitnejšie informácie o možných vedľajších účinkoch liekov. Dosiahnuť, aby sa pacienti intenzívnejšie zapájali do procesu nahlasovania vedľajších účinkov, je ústrednou súčasťou európskeho dohľadu nad liekmi a nový symbol po zavedení prispeje k posilneniu systému, ktorý je už dnes jedným z najrozvinutejších na svete," uviedol v tejto súvislosti eurokomisár pre zdravie a spotrebiteľskú politiku Tonio Borg.

Symbol sa bude vzťahovať na lieky povolené po 1.januári 2011, ktoré obsahujú novú účinnú látku, lieky vakcíny povolené po 1.januári 2011 a výrobky, pri ktorých je aj po vydaní povolenia potrebné doplniť dodatočné infromácie, alebo ich povolenie podlieha podmienkach alebo obmedzeniam týkajúcim sa bezpečného a účinného používania. Napriek tomu, že nové biologické lieky sú vyvinuté, aby sa podobali už existujúcim liekom, je nevyhnutné sledovanie ich bezpečnosti a účinnosti, keďže nemusia mať rovnakú štruktúru ako ich predchodca. Ďalším dôvodom je to, že testujúca vzorka pacientov pri klinických postupoch nemusia reprezentovať všetkých pacientov, ktorí budú v budúcnosti lieky užívať ( vedľajšie účinky niektorých liekov by sa mohli prejaviť, až po väčšom časovom období, než bol poskytnutý klinickým testom).

Doba označenia symbolom obráteného trojuholníka ( ktorý rozmermi nebude menší než 5 mm ) , nie je ničím ohraničená a produkt si ponechá toto označenie po celú dobu trvania predpokladov pre jeho použitie.

Aj po schválení lieku na trh sa jeho bezpečnosť celý čas v Európskej únií monitoruje, čo ma zabezpečiť rýchle stiahnutie lieku z trhu v prípade výskytu neočakávaných nežiadúcich účinkov. Takýto prístup sa považuje za jeden z najlepších a najkomplexnejších postupov pri ochrane verejného zdravia občanov Európskej únie.

spracoval: Peter Bobčík
zdroj: http://www.epda.eu.com/en/news/03-07-ec/

http://www.mhra.gov.uk/Safetyinformation/Howwemonitorthesafetyofproducts/Medicines/BlackTriangleproducts/index.htm




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