I-ANSM (Isikhungo Sikazwelonke Semithi Nemikhiqizo Yezempilo) ishicilele iphuzu lolwazi ngemithetho kagwayi we-elekthronikhi kuleli sonto. Ngemuva kwesikhumbuzo esilula sesimo se-e-cigarette, i-Ejensi ayikhohlwa ukubuza ukuthi i-vaporizer yomuntu siqu ibhekwe njengesidakamizwa futhi ukuthengiswa kwayo kubekelwe osokhemisi.
I-BIG PHARMA IDLALA IKHADI “LOMKHIQIZO WEZEMPILO” NGOKUQINISEKILE
Ngakho-ke i-ANSM ibuza lo mbuzo: “Ingabe ugwayi we-elekthronikhi ungaba umkhiqizo wezempilo? »
Empeleni, izimo ezimbili zingavela:
1- Ugwayi we-elekthronikhi kungenzeka ukuthi ungene ngokuzenzakalelayo emkhakheni wemikhiqizo yezempilo njengomuthi uma okungenani kufinyelelwa enye yalezi zindlela ezilandelayo:
- Isidingo sosizo lokuyeka ukubhema[3]
- Okuqukethwe kwe-Nicotine oketshezini ngaphezu komkhawulo osethelwe imikhiqizo eshisayo (20 mg/ml)
Kulokhu, umkhiqizo uzogunyazwa kabusha i-ejensi njengomuthi futhi ungahlala kuphela emakethe uma uthola ukugunyazwa kokumaketha (AMM).
2- Isicelo sokugunyazwa ukumaketha (MA) sekhatriji noma ibhodlela lokugcwalisa sithunyelwa ku-ANSM ngumkhiqizi, sizocutshungulwa ngokucophelela njenganoma yisiphi isicelo se-MA.
Kodwa-ke, kuze kube manje, awukho ugwayi we-elekthronikhi noma ibhodlela lokugcwalisa eline-MA njengesidakamizwa e-France, njengoba kungekho mkhiqizi ofake isicelo kulokhu.
Esimeni lapho i-cartridge yokugcwalisa kabusha noma ibhodlela, okuhloswe ngayo ukuyeka ukubhema, ithola i-MA njengomkhiqizo wokwelapha, idivayisi yokunikeza lo mkhiqizo womuthi izoba ngaphansi kwesimo sedivayisi yezokwelapha, njengesisetshenziswa sezokwelapha sokuphathwa komuthi. , ngokususelwe ku-athikili R.5211-2 yekhodi eshiwo ngenhla. Ngakho-ke kufanele ibe nokumaka kwe-CE ngaphansi kwe-Directive 93/42/EEC ephathelene nemishini yezokwelapha.
Ukuthengiswa kwemithi okudayiswayo kanye nokudayisa kanye nokunikezwa kwayo emphakathini kuyobe sekugcinelwa osokhemisi (isihloko L.4211-1 seKhodi Yezempilo Yomphakathi).
Umthombo : Ansm.sante.fr (Siyabonga kuMnu. Hammoudi)
