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Procedura de autorizare a preparatelor medicamentoase a fost simplificată

Procedura de autorizare a preparatelor medicamentoase a fost simplificată
medicamenteAgenția Medicamentului şi Dispozitivelor Medicale (AMDM) a simplificat procedura de autorizare a preparatelor medicamentoase pentru a relua imediat aprovizionarea cu medicamente de import, care lipsesc pe piaţa farmaceutică din ţară.
 
AMDM a făcut o evaluare a situației privind aprovizionarea cu medicamente, urmare a solicitării Guvernului, și a dispus realizarea unor măsuri de urgență care au ca scop asigurarea populației cu un spectru larg de preparate eficiente și de calitate.
Potrivit evaluării, pe piață lipsesc circa 60 de denumiri de preparate medicamentoase, 32 dintre care nu au analogi. „Printre motivele care au dus la dispariţia unor produse medicamentoase de pe piaţa autohtonă sînt neprelungirea de către importatori a Certificatului de înregistrare a preparatului, refuzul unor producători de a livra produse farmaceutice în R. Moldova pe motiv că preţurile de catalog nu acoperă costurile de producţie sau necorespunderea unor producători standardelor internaţionale, transpuse în legislaţia naţională”, a comunicat Serviciul de presă al AMDM.
AMDM a propus agenților economici condiţii atractive de înregistrare în R. Moldova a produselor farmaceutice noi, precum și au fost simplificate cerinţele privind etichetarea şi ambalajul produselor. Astfel, problema lipsei unor tipuri de medicamente de pe piaţa farmaceutică din  R. Moldova va fi soluţionată în cîteva săptămîni.
Totodată, Comisia pentru importul produselor farmaceutice a eliberat autorizațiile de import pentru 20 de denumiri de medicamente neînregistrate, vital necesare sistemului sănătăţii, iar pentru alte 12 decizia va fi luată în zilele următoare.
În același timp, AMDM a lansat negocieri cu producătorii internaţionali, care în ultimii ani s-au retras de pe piaţa farmaceutică a ţării, în vederea reluării conlucrării. Unii fabricanţi și-au manifestat deja interesul de a prezenta pachetul de documente pentru autorizarea medicamentelor produse.
La începutul acestei săptămîni, Prim-ministrul Pavel Filip a convocat reprezentanţii instituţiilor responsabile de implementarea Planului de acţiuni pentru soluționarea problemelor în domeniul farmaceutic pentru a discuta, punctual, acţiunile restante şi modalităţile de înlăturare a impedimentelor la punerea în practică a acestora. În cadrul şedinţei, Premierul a cerut „să fie luate toate măsurile necesare pentru a asigura buna desfăşurare a achiziţiilor centralizate a medicamentelor la nivel naţional, dar şi să fie intensificată activitatea de comunicare pe acest segment”.
În prezent, în Catalogul naţional de preţuri de producător sînt indicate costurile a 4.396 de medicamente, iar în Nomenclatorul de stat a medicamentelor sînt trecute 5.716 de denumiri a produselor farmaceutice. Doar în luna august curent au fost autorizate 256 de medicamente noi, 70% dintre acestea fiind fabricate în ţările UE.
Sursa: Moldpres

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