Ukunyanzeliswa kwezithambiso ze-FDA kuqala ukusebenza ngokusemthethweni

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Ukunyanzeliswa kwezithambiso ze-FDA kuqala ukusebenza ngokusemthethweni

umfanekiso 1

Ukubhaliswa kwe-FDA

Ngomhla woku-1 kuJulayi, ka-2024, i-US Food and Drug Administration (i-FDA) yalitshitshisa ngokusemthethweni ixesha lobabalo lokubhaliswa kwenkampani yezithambiso kunye noluhlu lwemveliso phantsi koMthetho we-Cosmetic Regulations of 2022 (MoCRA). Iinkampani ezingekagqibiUkubhaliswa kwe-FDAinokujongana nemingcipheko yokuvalelwa okanye ukwala ukungena eUnited States.

1. Ukunyanzeliswa kwezithambiso ze-FDA kusebenza ngokusemthethweni

Nge-29 kaDisemba, 2022, uMongameli wase-US u-Biden watyikitya kwaye wapasisa uMthetho we-2022 we-Cosmetic Regulations Act 2022 (MoCRA), oluluhlaziyo olubalulekileyo lwemithetho yezothambiso yase-US kule minyaka ingama-80 idlulileyo ukusukela ngo-1938. eUnited States okanye ngaphakathi ukugqiba ubhaliso lwe-FDA.

Ngomhla we-8 kaNovemba ka-2023, i-FDA yakhupha isikhokelo esichaza ukuba ukuze kuqinisekiswe ukuba iinkampani zinexesha elaneleyo lokungenisa ubhaliso lwazo, ixesha elongezelelweyo leenyanga ezi-6 linikezelwe ukuze i-FDA igqibezele zonke iimfuno zokuthobela nge-31 kaDisemba 2023. Ngomhla woku-1 kuJulayi, ngo-2024, iinkampani ezingekawugqibi umhla wokugqibela ziya kujongana nezohlwayo ezisisinyanzelo ezivela kwi-FDA.

Umhla obekiweyo womhla woku-1 kuJulayi ka-2024 uphelelwe, kwaye unyanzeliso olusisinyanzelo lwe-FDA lwezithambiso luqalisile ukusebenza ngokusemthethweni. Zonke iinkampani zokuthambisa ezithumela ngaphandle eMelika kufuneka zinike ingqwalasela eyodwa ekugqibezeleni ukubhaliswa kwamashishini kunye noluhlu lweemveliso ngaphambi kokuba zithumele ngaphandle, kungenjalo ziya kujongana nemingcipheko efana nokwaliwa kokungena kunye nokuhluthwa kwempahla.

2. IiMfuno zokuThotyelwa koBhaliso lwe-Cosmetic ye-FDA

Ubhaliso lweZiko

Iifektri zokuthambisa ezibandakanyeka kwimveliso, ukulungisa, kunye nokuthengisa eUnited States kufuneka zibhalise njengamashishini. Umenzi wekhontrakthi, nokuba zingaphi na iibrendi azenza ikontraka, kufuneka abhalise kube kanye kuphela. Iinkampani ezingezizo zase-US nazo kufuneka zonyule i-arhente yase-US ukumela inkampani kunxibelelwano kunye noqhagamshelwano ne-US FDA. Iiarhente zase-US kufuneka zibekwe ngokwasemzimbeni eUnited States kwaye zikwazi ukuphendula imibuzo ye-FDA nge-7/24.

Uluhlu lweeMveliso

Umntu onoxanduva kufuneka abhalise imveliso. Abavelisi, abapakishi, abasasazi, okanye abanini bebrendi amagama abo avela kwiileyibhile zezithambiso kufuneka badwelise iimveliso kwaye babhengeze ifomula ethile kwi-FDA. Ukongeza, "umntu onoxanduva" uya kuba noxanduva lwezehlo ezingalunganga, isiqinisekiso sokhuseleko, ukuleyibhile, ukubhengeza kunye nokurekhodwa kwezinto ezingalunganga kwiziqholo.
La mashishini abhalisiweyo angasentla kunye neemveliso ezidweliswe kwimarike kufuneka agqibe ukuthobela ngaphambi komhla woku-1 kuJulayi, 2024!

Ukuthotyelwa kophawu lwemveliso

Kufuneka ihambelane noMthetho wokuPakisha nokuFakwa okuLungileyo (i-FPLA) kunye neminye imimiselo esebenzayo.

Umntu woQhagamshelwano noMnyhadala ombi (AER)

Phambi komhla wama-29 kuDisemba 2024, ileyibhile nganye yezithambiso kufuneka ibonise ulwazi lomntu oqhagamshelwana naye malunga nengxelo yesiganeko esibi, esetyenziselwa ukufumana iingxelo zesiganeko esibi.
3. IiMfuno zoHlaziyo lwe-Cosmetic ye-FDA
Iimfuno zohlaziyo lobhaliso lweshishini:
·Ubhaliso lweshishini kufuneka luhlaziywe rhoqo emva kweminyaka emibini
·Naluphi na utshintsho kulwazi kufuneka luxelwe kwi-FDA phakathi kweentsuku ezingama-60, ezifana:
Iinkcukacha zoqhakamshelwano
uhlobo lwemveliso
Uphawu, njl
·Zonke iinkampani ezingezizo zase-US kufuneka zikhethe i-arhente yase-US, kwaye uhlaziyo lwexesha lenkonzo yomenzeli wase-US nalo kufuneka luqinisekiswe kunye ne-arhente.
✔ IiMfuno zoHlaziyo loLuhlu lweeMveliso:
·Umntu onoxanduva lokudwelisa imveliso kufuneka ahlaziye ukubhaliswa kwemveliso rhoqo ngonyaka, kuquka naluphi na utshintsho
·Umntu onoxanduva kufuneka angenise uluhlu lwemveliso yezithambiso nganye phambi kokuba adweliswe, kwaye angangenisa ngokuguquguqukayo uluhlu lweemveliso zokuthambisa ngaxeshanye.
Susa uluhlu lweemveliso eziyekiweyo, oko kukuthi, cima igama loluhlu lwemveliso


Ixesha lokuposa: Jul-09-2024