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[title] => Agencija za lijekove objavila priopćenje o odobrenju cjepiva protiv koronavirusa u Hrvatskoj: ‘Potvrdit će se djelotvornost, sigurnost i kakvoća‘
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Nakon objave da je Europska agencija za lijekove (EMA) potvrdila kako će se sastati 21. prosinca na izvanrednom sastanku vezanom za odobrenje cjepiva protiv koronavirusa, oglasila se i Agencija za lijekove i medicinske proizvode u Hrvatskoj (HALMED).
- Povjerenstvo za humane lijekove (CHMP) će na sjednici zaključiti svoju znanstveno-stručnu ocjenu predmetnog cjepiva protiv bolesti covid-19 pod uvjetom da na temelju dostavljenih podataka bude moguće provesti temeljitu ocjenu te potvrditi djelotvornost, sigurnost i kakvoću cjepiva. Sjednica je zakazana nakon zaprimanja dodatnih podataka koje je CHMP u postupku ocjene zatražio od proizvođača. Prethodno najavljena izvanredna sjednica koja je bila planirana 29. prosinca održat će se prema potrebi.
CHMP će svoju ocjenu zaključiti u najkraćem mogućem roku, kada se potvrdi da je cjepivo odgovarajuće u pogledu kakvoće, sigurnosti i djelotvornosti, odnosno kada se utvrdi da su koristi primjene cjepiva veće od rizika.
Nakon što CHMP preporuči davanje odobravanja za cjepivo, Europska komisija će u sljedećih nekoliko dana ubrzati postupak donošenja odluke s ciljem davanja odobrenja za stavljanje u promet koje će vrijediti u svim državama članicama Europske unije i zemljama Europskog gospodarskog prostora, pa tako i u Republici Hrvatskoj, priopćili su iz HALMED-a.
Navedeno odobrenje uključivat će uobičajene mjere opreza, kontrolne mehanizme i obveze, a to su redom:
- potpune informacije o propisivanju i dokumenti s detaljnim uputama za sigurnu primjenu
- detaljni plan upravljanja rizikom i praćenja sigurnosti
- kontrola proizvodnje, uključujući provjeru kakvoće serija cjepiva i uvjete skladištenja
- lan istraživanja za pedijatrijsku populaciju
- pravno obvezujuće uvjete nakon davanja odobrenja i jasan pravni okvir za ocjenu novih podataka o djelotvornosti i sigurnosti.
- Odobrenje za stavljanje u promet jamči da cjepiva protiv bolesti COVID-19 udovoljavaju istim visokim europskim standardima kao i sva druga cjepiva i lijekovi. Navedeno odobrenje vrijedit će na prostoru cijelog EU-a, što će omogućiti svim državama članicama da istodobno započnu s provođenjem cijepljenja, poručuju iz HALMED-a.
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Nakon objave da je Europska agencija za lijekove (EMA) potvrdila kako će se sastati 21. prosinca na izvanrednom sastanku vezanom za odobrenje cjepiva protiv koronavirusa, oglasila se i Agencija za lijekove i medicinske proizvode u Hrvatskoj (HALMED).
- Povjerenstvo za humane lijekove (CHMP) će na sjednici zaključiti svoju znanstveno-stručnu ocjenu predmetnog cjepiva protiv bolesti covid-19 pod uvjetom da na temelju dostavljenih podataka bude moguće provesti temeljitu ocjenu te potvrditi djelotvornost, sigurnost i kakvoću cjepiva. Sjednica je zakazana nakon zaprimanja dodatnih podataka koje je CHMP u postupku ocjene zatražio od proizvođača. Prethodno najavljena izvanredna sjednica koja je bila planirana 29. prosinca održat će se prema potrebi.
CHMP će svoju ocjenu zaključiti u najkraćem mogućem roku, kada se potvrdi da je cjepivo odgovarajuće u pogledu kakvoće, sigurnosti i djelotvornosti, odnosno kada se utvrdi da su koristi primjene cjepiva veće od rizika.
Nakon što CHMP preporuči davanje odobravanja za cjepivo, Europska komisija će u sljedećih nekoliko dana ubrzati postupak donošenja odluke s ciljem davanja odobrenja za stavljanje u promet koje će vrijediti u svim državama članicama Europske unije i zemljama Europskog gospodarskog prostora, pa tako i u Republici Hrvatskoj, priopćili su iz HALMED-a.
Navedeno odobrenje uključivat će uobičajene mjere opreza, kontrolne mehanizme i obveze, a to su redom:
- potpune informacije o propisivanju i dokumenti s detaljnim uputama za sigurnu primjenu
- detaljni plan upravljanja rizikom i praćenja sigurnosti
- kontrola proizvodnje, uključujući provjeru kakvoće serija cjepiva i uvjete skladištenja
- lan istraživanja za pedijatrijsku populaciju
- pravno obvezujuće uvjete nakon davanja odobrenja i jasan pravni okvir za ocjenu novih podataka o djelotvornosti i sigurnosti.
- Odobrenje za stavljanje u promet jamči da cjepiva protiv bolesti COVID-19 udovoljavaju istim visokim europskim standardima kao i sva druga cjepiva i lijekovi. Navedeno odobrenje vrijedit će na prostoru cijelog EU-a, što će omogućiti svim državama članicama da istodobno započnu s provođenjem cijepljenja, poručuju iz HALMED-a.
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14. svibanj 2024 15:09
