Uko wa Kwandikisha imiti ikoreshwa mu buhinzi ikoze mu binyabutabire

Iyi serivisi igenewe ibigo byifuza kugurisha cyangwa gukora imiti yica udukoko ikomoka ku binyabutabire mu Rwanda, kugira ngo byemererwe kwitabira igeragezwa ry’imikorere (efficacy trial) nyuma yo gusuzumwa no kwemezwa n’Ikigo cy’Igihugu gishinzwe Ubugenzuzi, Ihangana mu Bucuruzi n’Uburenganzira bw’Abaguzi (RICA).

Nyuma yo gutsinda neza iryo geragezwa, ikigo gihabwa icyemezo cy’iyandikwa ry’ibicuruzwa

Ibisabwa mbere yo gusaba

Kugira ngo utangire gusaba, ukeneye ibi bikurikira:

• Konti ikora kuri OneStopCenter. Gufungura konti, kanda hano.

• Nomero ya TIN yemewe aho bikenewe

• Nomero ya telefone igendanwa ikora cyangwa imeyili yemewe.
  
  

Ibisabwa rusange

• Kugira umuhuza (local agent) wiyandikishije mu Rwanda

• Gutanga urugero (sample) rw’umuti kugira ngo rujyanwe mu ipima

Inyandiko zisabwa

• Kopi y’icyemezo cy’iyandikwa ry’umuti wica udukoko ugiye kwandikwa, gitangwa n’igihugu ukomokamo cyangwa ikindi gihugu

• Icyemezo cy’iyandikwa ry’ubucuruzi gitangwa na RDB

• Icyemezo cy’impamyabumenyi n’amasezerano y’abakozi b’inzobere mu bya tekiniki

• Icyemezo cy’isuzuma ry’umuti (certificate of product analysis)

• Kopi ya dosiye ya tekiniki (technical dossier) igaragaza ibisobanuro birambuye ku bigize umuti (active ingredients) n’uko uteguye

• Icyitegererezo cy’ikirango (label) cy’umuti cyateguwe hakurikijwe amabwiriza y’ikirango yometseho

• Urupapuro rwerekana umutekano w’ibikoresho n’imiti (Material Safety Data Sheet – MSDS)

• Umushinga wateguwe w’igeragezwa ry’imikorere (efficacy trial protocol) ujyanye n’amabwiriza ya EAC ku isuzuma no gutanga raporo ku mikorere y’imiti yica udukoko

• Kopi ya pasiporo

• Icyemezo cy’iyandikwa muri RICA

Inyandiko zitari itegeko 

• Ibaruwa y’uburenganzira itangwa n’uwakoze umuti

• Icyemezo kigaragaza uko ipatanti (patent) y’umuti ihagaze n’itariki izarangiriraho

• Ibyavuye mu bipimo bya laboratwari

Igihe bitwara n’igiciro

Intambwe zikurikira n’amakuru y’ubufasha

1. Gutanga ubusabe:

Nyuma yo gutanga ubusabe neza, usaba ahabwa nimero yo kwishyura (urugero: 88…) ikoreshwa mu kwishyura.

2. Kwishyura:

• Hazatangwa nimero/ID yo kwishyura. Kanda kuri Ishyura kugira ngo urangize kwishyura.

• Ushobora guhitamo uburyo bwo kwishyura wifuza.
  
  

3. Gutanga icyemezo/uruhushya:

Iyo ubusabe bwemejwe, uzahabwa uruhushya rwawe rw’ikoranabuhanga (e-license).

Kubona ubufasha cyangwa ibisobanuro birambuye:

• Hamagara: 1415

• Imeyili: support@rdb.rw

• Twandikire kuri WhatsApp: 0788321555