' Imithetho Yokuqondisa Nokuphathwa Kwamadivayisi Ezokwelapha ' esanda kubuyekezwa ( Isimemezelo SoMkhandlu Kazwelonke No.739, kamuva esibizwa ngokuthi ' Imithethonqubo ') izoqala ukusebenza ngomhla ka-1 Juni 2021.I-National Drug Administration ihlela ukulungiswa nokubuyekezwa kwemithethonqubo esekelayo, imibhalo evamile kanye nemihlahlandlela yezobuchwepheshe, ezoshicilelwa ngokuhambisana nezinqubo.Izimemezelo zokusetshenziswa ' Kwemithethonqubo ' emisha zimi kanje :
1. Ekusetshenzisweni ngokugcwele kokubhaliswa kwedivayisi yezokwelapha, uhlelo lokugcwalisa
Kusukela ngomhlaka-1 Juni 2021, zonke izinkampani nezikhungo zokuthuthukiswa kwemishini yezokwelapha ezinezitifiketi zokubhaliswa kwemishini yezokwelapha noma eziye zasingatha ukufakwa kwemishini yezokwelapha yeSigaba I, ngokuhambisana nezinhlinzeko zeMithetho emisha, ziyofeza izibopho zababhalisile bemishini yezokwelapha namafayili. ngokulandelana, ukuqinisa ukuphathwa kwekhwalithi yemishini yezokwelapha kuwo wonke umjikelezo wempilo, futhi uthathe umthwalo wemfanelo wokuphepha nokusebenza ngempumelelo kwemishini yezokwelapha kuyo yonke inqubo yocwaningo, ukukhiqizwa, ukusebenza nokusetshenziswa ngokomthetho.
2. Ekubhaliseni idivayisi yezokwelapha, ukuphathwa kwefayela
Kusukela ngomhla ka-1 Juni 2021, ngaphambi kokukhishwa nokusebenzisa imibandela efanelekile yokubhaliswa nokugcwaliswa 'kweMithetho' emisha, abafake izicelo zokubhaliswa kwemishini yezokwelapha namafayili bayaqhubeka nokufaka izicelo zokubhaliswa nokugcwalisa ngokuvumelana nemithetho yamanje.Izidingo zokuhlolwa komtholampilo kwemishini yezokwelapha zizosetshenziswa ngokuvumelana ne-Athikili 3 yalesi Simemezelo.Umnyango wokuqondisa nokuphatha izidakamizwa wenza umsebenzi ohlobene nokubhalisa nokugcwalisa ngokuhambisana nezinqubo zamanje kanye nemikhawulo yesikhathi.
3. Ukuphathwa Kokuhlolwa Komtholampilo Kwamadivayisi Ezokwelapha
Kusukela ngomhlaka-1 Juni 2021, abafake izicelo zokubhaliswa kwemishini yezokwelapha namafayili bazohlola umtholampilo ngokuvumelana 'Nezimiso' ezintsha.labo abathobelana nezinhlinzeko 'zeMithetho' emisha bangase bakhululwe ekuhlolweni komtholampilo ;ukuhlolwa komtholampilo kungase kusekelwe kuzici zomkhiqizo, ubungozi bomtholampilo, idatha yomtholampilo ekhona, njll., ngezivivinyo zomtholampilo, noma ngezinhlobonhlobo ezifanayo zezincwadi zomtholampilo zemishini yezokwelapha, ukuhlaziywa kwedatha yomtholampilo kanye nokuhlola ukuze kuqinisekiswe ukuthi imishini yezokwelapha iphephile futhi isebenza ngempumelelo ;izincwadi zomtholampilo ezikhona, idatha yomtholampilo ayanele ukuqinisekisa ukuphepha komkhiqizo, imishini yezokwelapha ephumelelayo, kufanele yenze ukuhlolwa kwemitholampilo.Ngaphambi kokukhishwa nokusetshenziswa kwamadokhumenti afanelekile akhululiwe ekuhlolweni komtholampilo, uhlu lwamathuluzi ezokwelapha akhululiwe ekuhlolweni komtholampilo lusetshenziswa ngokubhekisela kuhlu lwamanje lwemishini yezokwelapha ekhululiwe ekuhlolweni komtholampilo.
4.Mayelana nelayisense yokukhiqiza idivayisi yezokwelapha, ukuphathwa kokugcwalisa
Ngaphambi kokukhishwa nokuqaliswa kwezinhlinzeko ezifanele 'zeMithetho' emisha esekela amalayisense okukhiqiza nokufakwa, ababhalisi bemishini yezokwelapha namafayili baphatha amalayisense okukhiqiza, ukugcwalisa kanye nokukhiqiza okugunyaziwe ngokuhambisana nemithetho ekhona kanye nemibhalo evamile.
5.Kulayisense yebhizinisi ledivayisi yezokwelapha, ukuphathwa kokugcwalisa
Idivayisi yezokwelapha ebhaliswe noma ebhaliswe ngomshini wezokwelapha obhalisiwe noma obhalisiwe othengisa idivayisi yezokwelapha ebhalisiwe noma ebhaliswe lapho ehlala khona noma ikheli lokukhiqiza ayidingi ilayisense yebhizinisi ledivaysi yezokwelapha noma ukubhaliswa, kodwa kufanele ihambisane nezimo zokusebenza ezinqunyiwe;uma uhlobo lwesibili nolwesithathu lwezisetshenziswa zezokwelapha zigcinwa futhi zidayiswa kwezinye izindawo, ilayisense yebhizinisi lensiza yezokwelapha noma irekhodi kufanele licutshungulwe ngokuvumelana nezinhlinzeko.
I-State Drug Administration ibhale ikhathalogi yemikhiqizo yemishini yezokwelapha yesigaba II ekhululiwe ekubhaliseni ibhizinisi futhi ifuna izeluleko zomphakathi.Ngemva kokukhishwa kwekhathalogi yomkhiqizo, landela ikhathalogi.
6.Uphenyo kanye nokujeziswa kokuziphatha okungekho emthethweni kwemishini yezokwelapha
Uma ukuziphatha okungekho emthethweni kwemishini yezokwelapha kwenzekile ngaphambi komhla 1 Juni, 2021, “Imithetho” ngaphambi kokubuyekezwa izosetshenziswa.Nokho, uma “ Imithetho ” entsha ibona ukuthi akukho emthethweni noma isijeziso silula, kuzosetshenziswa “ Imithethonqubo ” emisha.'Imithethonqubo' emisha iyasebenza lapho icala lenzeke khona ngemva komhla lu-1 kuJuni 2021.
Kuyamenyezelwa ngalokhu.
I-National Drug Administration
Meyi 31, 2021
Isikhathi sokuthumela: Jun-01-2021