Dukurikije "Itegeko rigenga ibiyobyabwenge muri Repubulika y’Ubushinwa" n "" Amategeko agenga inkingo muri Repubulika y’Ubushinwa ", hagamijwe kugenzura no kuyobora ibikorwa bya farumasi y’imiti y’abafite uburenganzira bwo gucuruza ibiyobyabwenge n’abasaba kwandikisha ibiyobyabwenge, ibiyobyabwenge bya Leta Ubuyobozi bwateguye kandi bushiraho "Imicungire y’ubuziranenge bwa Pharmacovigilance Amabwiriza aratangazwa, kandi ibibazo bijyanye n’ishyirwa mu bikorwa ry’imicungire y’ubuziranenge bwa Pharmacovigilance byatangajwe ku buryo bukurikira:

1. "Ibipimo ngenderwaho by’imicungire y’imiti" bizashyirwa mu bikorwa ku ya 1 Ukuboza 2021.

2. Abafite uruhushya rwo kwamamaza ibiyobyabwenge hamwe n’abasaba kwandikisha ibiyobyabwenge bagomba kwitegura byimazeyo ishyirwa mu bikorwa ry’amabwiriza agenga imicungire y’ubuziranenge bwa Pharmacological Vigilance, bagashyiraho kandi bagahora batezimbere uburyo bwa farumasi nkuko bisabwa, kandi bagahindura iterambere ryibikorwa bya farumasi.

3. Ufite uruhushya rwo gucuruza ibiyobyabwenge agomba kuzuza amakuru muri sisitemu y’igihugu ishinzwe kugenzura ibiyobyabwenge mu gihe kitarenze iminsi 60 uhereye igihe yatangarijwe.

4. Inzego zishinzwe kugenzura ibiyobyabwenge mu ntara zirasaba abafite uburenganzira bwo kwamamaza ibiyobyabwenge mu turere batuyemo kwitegura byimazeyo kumenyekanisha, kubishyira mu bikorwa no kubisobanura, no kugenzura no kuyobora uruhushya rwo gucuruza ibiyobyabwenge binyuze mu gushimangira ubugenzuzi busanzwe. Ufite nyirubwite ashyira mu bikorwa "Amabwiriza agenga imicungire y’ubuziranenge bwa Pharmacologique" nkuko bisabwa, kandi akusanya kandi agaburira ibibazo nibitekerezo bijyanye mugihe gikwiye.

5 ibitekerezo mugihe gikwiye.

Itangazo ridasanzwe.