ANSM (National Agency for Medicines and Health Products) adasindikiza mfundo yodziwitsa za malamulo a ndudu yamagetsi sabata ino. Pambuyo pa chikumbutso chosavuta cha mkhalidwe wa ndudu ya e-fodya, Bungwe siliyiwala kufunsa kuti vaporizer yaumwini ionedwe ngati mankhwala ndipo kugulitsa kwake kusungidwe kwa ogulitsa mankhwala.
PHARMA WABWINO AMASEWERA KHADI LA "HEALTH PRODUCT" MOBWINO
Chotero ANSM ikufunsa funso lakuti: “Kodi ndudu yamagetsi ingakhale chinthu chathanzi? »
M'malo mwake, zinthu ziwiri zimatha kuchitika:
1- Ndudu yamagetsi imatha kulowa muzamankhwala ngati mankhwala ngati chimodzi mwazinthu izi chikukwaniritsidwa:
- Kufuna thandizo losiya kusuta[3]
- Chikonga chamadzimadzi chomwe chili pamwamba pa chiwombankhanga chomwe chimayikidwa pazitsulo zamagetsi (20 mg/ml)
Pachifukwa ichi, malondawo amavomerezedwa ndi bungwe ngati mankhwala ndipo atha kukhalabe pamsika ngati atalandira chilolezo chotsatsa (AMM).
2- Pempho lachilolezo cha malonda (MA) la cartridge kapena botolo lodzazanso laperekedwa kwa ANSM ndi wopanga, lidzawunikidwa mosamala ngati pempho lililonse la MA.
Komabe, mpaka pano, palibe ndudu yamagetsi kapena botolo lowonjezera lomwe lili ndi MA monga mankhwala ku France, popeza palibe wopanga amene adalembapo izi.
Kukachitika kuti katiriji kapena botolo, lomwe cholinga chake chinali kusiya kusuta, litapeza MA ngati mankhwala, chipangizo choperekera mankhwalawa chidzakhala pansi pa udindo wa chipangizo chachipatala, ngati chipangizo chachipatala chogwiritsira ntchito mankhwala. , motsatira nkhani R.5211-2 ya code yomwe tatchulayi. Chifukwa chake, iyenera kukhala ndi chizindikiritso cha CE pansi pa Directive 93/42/EEC yokhudzana ndi zida zamankhwala.
Kugulitsa kwamankhwala ndi kugulitsa mankhwalawo komanso kuperekedwa kwawo kwa anthu kudzakhala kwa azachipatala (nkhani L.4211-1 ya Public Health Code).
gwero : Ansm.sante.fr (Zikomo kwa Mr. Hammoudi)
