Ngomhla zi-1 kuJulayi, 2024, i-US Food and Drug Administration (FDA) yenza ngokusemthethweni isikhathi somusa sokubhaliswa kwenkampani yezimonyo nokufakwa kuhlu kwemikhiqizo ngaphansi kwe-Modernization of Cosmetic Regulations Act ka-2022 (MoCRA). Izinkampani ezingakaqediUkubhaliswa kwe-FDAingase ibhekane nezingozi zokuboshwa noma ukwenqaba ukungena e-United States.
1. Ukusetshenziswa kwezimonyo ze-FDA kuqala ukusebenza ngokusemthethweni
Ngomhla zingama-29 kuZibandlela wezi-2022, uMongameli wase-US u-Biden wasayina futhi waphasisa uMthetho Wesimanje Wemithetho Yezimonyo 2022 (MoCRA), okuwushintsho olubalulekile lwemithetho yezimonyo yase-US eminyakeni engama-80 edlule kusukela ngo-1938. Le mithetho emisha idinga ukuthi zonke izinkampani zezimonyo zithumele emazweni angaphandle. E-United States noma ngaphakathi ukuze uqedele ukubhaliswa kwe-FDA.
Ngomhla ziyisi-8 Novemba 2023, i-FDA yakhipha umhlahlandlela othi ukuze kuqinisekiswe ukuthi izinkampani zinesikhathi esengeziwe esanele sokuhambisa ukubhaliswa kwazo, kunikezwe isikhathi esengeziwe somusa sezinyanga eziyisi-6 ukuze i-FDA iqedele zonke izidingo zokuthobela ngo-December 31, 2023. Ngomhla lu-1 kuJulayi, 2024, izinkampani ezingakaqedi umnqamulajuqu zizobhekana nezijeziso eziyisibopho ezivela ku-FDA.
Umnqamulajuqu wangomhla lu-1 kuJulayi 2024 uphelelwe yisikhathi, futhi ukuphoqelela ukusetshenziswa kwezimonyo kwe-FDA kuqale ukusebenza ngokusemthethweni. Zonke izinkampani zezimonyo ezithumela e-United States kufanele zinake ngokukhethekile ukuqedela ukubhaliswa kwebhizinisi nokufakwa kuhlu kwemikhiqizo ngaphambi kokuyithumela ngaphandle, ngaphandle kwalokho zizobhekana nezingozi ezinjengokwenqaba ukungena nokuthathwa kwezimpahla.
2. Izidingo Zokuthobela Ukubhaliswa Kwezimonyo ze-FDA
Izimboni zezimonyo ezibandakanyeka ekukhiqizeni, ekucubungulweni nasekuthengisweni e-United States kumele zibhalise njengamabhizinisi. Umkhiqizi wenkontileka, kungakhathaliseki ukuthi mangaki amabhrendi enza inkontileka, udinga ukubhalisa kanye kuphela. Izinkampani okungezona zase-US kumele futhi ziqoke i-ejenti yase-US ezomela inkampani ekuxhumaneni nasekuxhumaneni ne-US FDA. Abenzeli base-US kumele babe ngokoqobo e-United States futhi bakwazi ukuphendula imibuzo ye-FDA ngomhla ka-7/24.
Umuntu onesibopho kufanele abhalise umkhiqizo. Abakhiqizi, abaphakeji, abasabalalisi, noma abanikazi bomkhiqizo amagama abo avela kumalebula ezimonyo kumele bafake ohlwini imikhiqizo futhi bamemezele ifomula ethile ku-FDA. Ngaphezu kwalokho, "umuntu onesibopho" uzophinde abe nesibopho sezehlakalo ezingezinhle, ukuqinisekiswa kokuphepha, ukulebula, nokudalula kanye nokuqopha izinto ezingezwani nezinongo.
Amabhizinisi abhalisiwe ngenhla nemikhiqizo esohlwini lwemakethe kufanele aqedele ukuthobela umthetho ngaphambi komhla lu-1 kuJulayi 2024!
Kufanele ihambisane noMthetho Wokupakisha Nokulebula Okuhle (i-FPLA) neminye imithetho esebenzayo.
Ngaphambi komhla zingama-29 kuZibandlela 2024, ilebula ngayinye yezimonyo kufanele ibonise ulwazi lomuntu oxhumana naye ukuze kubikwe izenzakalo ezimbi, ezisetshenziselwa ukuthola imibiko yezenzakalo ezimbi.
3. Izidingo Zokuvuselela Izimonyo ze-FDA
Izidingo zokubuyekeza ukubhaliswa kwebhizinisi:
·Ukubhaliswa kwebhizinisi kufanele kubuyekezwe njalo eminyakeni emibili
·Noma yiziphi izinguquko olwazini kufanele zibikwe ku-FDA zingakapheli izinsuku ezingama-60, njengalezi:
Ulwazi lokuxhumana
uhlobo lomkhiqizo
Ibhrendi, njll
·Zonke izinkampani okungezona zase-US kufanele ziqoke i-ejenti yase-US, futhi izibuyekezo zesikhathi sesevisi ye-ejenti yase-US nazo zidinga ukuqinisekiswa ne-ejenti.
✔ Izidingo Zokubuyekezwa Kohlu Lomkhiqizo:
·Umuntu obhekele ukufakwa kuhlu kwemikhiqizo kufanele abuyekeze ukubhaliswa komkhiqizo minyaka yonke, okuhlanganisa nanoma yiziphi izinguquko
·Umuntu onomthwalo wemfanelo kufanele alethe uhlu lomkhiqizo ngamunye wezimonyo ngaphambi kokufakwa ohlwini, futhi angahambisa kalula uhlu lwemikhiqizo yezimonyo eminingi ngesikhathi esisodwa.
Susa ohlwini imikhiqizo eyekiwe, okungukuthi, susa igama lohlu lomkhiqizo
Isikhathi sokuthumela: Jul-09-2024
