Bioparox, registrácia, pozastavenie a zrušenie registrácie lieku | Medicínske právo
              

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Bioparox, registrácia, pozastavenie a zrušenie registrácie lieku


 | 2.3.2016 | komentárov: 294

Bioparox, voľne predajné antibiotikum používané na liečbu zápalov a infekcií sliznice a dýchacích ciest má podľa Európskej liekovej agentúry (EMA), prísť o registráciu na celom území Európy.

Obrazok

Toto odporúčanie je založené na zvýšení výskytu alergických reakcií na lieky užívané v kombinácii s látkou  fusafungín, ktorú Bioparox obsahuje. V Českej republike medzičasom Štátny ústav pre kontrolu liečiv vydal odporúčanie nepoužívať antibiotikum v dôsledku čoho sa postupne sťahuje z predaja. Slovenský Štátny ústav pre kontrolu liečiv zatiaľ v súvislosti s liekom nepodnikol žiadne kroky a v súčasnosti je stále dostupný v lekárňach. Obe organizácie  zabezpečujúce dozor nad kvalitou liečiv  momentálne čakajú na rozhodnutie Európskej komisie, v dôsledku čoho môže byť lieku zrušená registrácia na území oboch štátov.

Registráciou lieku rozumieme proces na základe, ktorého sa vydá povolenie, ktoré oprávňuje osobu uviesť svoj liek na trh. Rozhodnutia o  registrácii  humánnych liekov vydáva Štátny ústav pre kontrolu liečiv alebo Európska komisia, ak ide  o humánne lieky registrované podľa osobitných predpisov. Registrácia lieku sa realizuje na základe žiadosti, ktorú  predkladá fyzická alebo právnická osoba Štátnemu ústavu pre kontrolu liečiv. Ten následne posúdi najmä, či daný humanitárny liek podľa predloženej dokumentácie, spĺňa požiadavky účinnosti, bezpečnosti a kvality, či názov humánneho lieku neodporuje jeho zloženiu a liečivým účinkom a či nie je zameniteľný s názvom iného už registrovaného humánneho lieku alebo či sa v priebehu klinického skúšania a výroby humánneho lieku splnili požiadavky správnej klinickej praxe.

Pre úplnosť treba dodať, že Štátny ústav pre kontrolu liečiv  má aj oprávnenie pozastaviť alebo zrušiť registráciu humánneho lieku. Pozastavenie  registrácie je možné za splnenia požiadaviek uvedených v §56 ods.1 a ods.3  zákona č. 362/2011 Z. z. o liekoch a zdravotníckych pomôckach a o zmene a doplnení niektorých zákonov(ďalej len „zákon č. 362/2011 Z. z.“). V prípade takéhoto pozastavenia registrácie je následne výdaj takéhoto humánneho lieku  zakázaný. Ak štátny ústav pre kontrolu liečiv zruší registráciu daného lieku a to na základe podmienok uvedených v §56 ods.4 zákona č. 362/2011 Z. z., tento liek sa následne stiahne z trhu.

 

Zdroj:  http://www.sukl.cz/fusafungin-bioparox-doporuceno-zruseni-registrace

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