Cc quy nh lin quan n qung co thuc.
BO CO DC LM SNGCH : Cc quy nh lin quan n qung co thuc. So Snh vi
mt s nc.T 6 Nhm 3: L Nguyn Khnh HV Vn Hiinh Th Hn Th HngVn Trn Ngc
Hng
NI DUNG
I. im khc nhau v quy nh qung co gia Vit nam so vi Hoa K.II. im
khc nhau v quy nh qung co gia Vit Nam vi Anh.III. im khc nhau v quy
nh qung co thuc gia Vit Nam vi Trung Quc.
B. Mt s im khc nhau trong quy nh qung co thuc Vit Nam so vi mt s
nc
A. Quy nh qung co thuc Vit Nam
Thuc l cht hoc hn hp cc cht dng cho ngi nhm mc ch phng bnh, cha
bnh, chn on bnh hoc iu chnh chc nng sinh l c th bao gm: thuc thnh
phm.nguyn liu lm thuc.vaccine, sinh phm y t.tr thc phm chc nng.Qung
co thuc l hot ng gii thiu thuc do n v kinh doanh thuc trc tip tin
hnh hoc phi hp, hoc ti tr, u quyn cho mt n v khc tin hnh thc y vic
k n, cung ng, bn v/hoc s dng thuc trn c s s dng thuc hp l, an ton v
hiu qu.
Ch n v ng k thuc c ng k h s qung co thuc do mnh ng k. Trng hp n
v ng k thuc mun u quyn cho n v khc ng k h s qung co th phi c vn bn
u quyn. n v c u quyn phi l n v c t cch php nhn hp php.Thuc c cp s
ng k lu hnh ti Vit Nam c qung co theo cc quy nh. Thuc cha c cp s ng
k lu hnh ti Vit Nam nhng c php lu hnh nc khc ch c thng tin cho cn b
y t thng qua hi tho gii thiu thuc.Ni dung qung co thuc phi bo m tnh
khoa hc, khch quan, chnh xc, trung thc, r rng v khng c gy hiu
lm.
4. Ting ni v ch vit dng trong qung co l ting Vit, tr trng hp t
ng c quc t ho hoc thng hiu, t ng khng thay th c bng ting Vit.5. C
ch b nht trong qung co phi ln c th nhn thy trong iu kin bnh thng
nhng khng c b hn c ch tng ng c 11 VnTime.6. n v qung co thuc phi
chu trch nhim v ni dung, tnh php l nhng thng tin cung cp trong cc
hot ng qung co thuc ca mnh.
n vng k qung co thuc theo quy nh ti Thng t ban hnh phi np ph thm
nh h s ti c quan tip nhn h s ng k thng tin, qung co thuc theo quy
nh ca php lut hin hnh.Mt mu qung co thuc tng ng vi mt h s ng k qung
co thuc phi np ph thm nh nh sau:Trng hp c coi l mt h s ng k qung co
thuc khi p ng mt trong cc trng hp sau: Mt mu qung co cho mt i tng
ca mt thuc c mt hm lng, mt dng bo ch.Mt mu qung co cho mt i tng ca
hai hay nhiu thuc c cng hot cht nhng c hm lng, dng bo ch, ng dng
khc nhau ca cng mt nh sn xut. Mt mu qung co ca mt thuc cho mt i tng
trn nhiu hnh thc (v d: t ri, p phch, sch, bo, ).
b) Trng hp khng c coi l mt h s qung co thuc: Mt thuc c qung co
cho mt i tng nhng c nhiu mu qung co khc nhau. Trng hp ny mi mu qung
co c coi l mt h s qung co thuc.Mt mu qung co cho mt i tng nhng gm
nhiu thuc khc nhau. Trng hp ny mi thuc c coi l mt h s ng k qung co
thuc.
1. Qung co thuc k n, vc xin, sinh phm y t dng phng bnh; thuc
khng phi k n nhng c c quan qun l Nh nc c thm quyn khuyn co bng vn
bn s dng hn ch hoc s dng c s gim st ca thy thuc. 2. Qung co m phm,
thc phm chc nng v cc sn phm khng phi l thuc vi ni dung khng r rng c
th khin ngi tiu dng hiu nhm sn phm l thuc. 3. S dng li ch vt cht
hay ti chnh di mi hnh thc tc ng ti thy thuc, ngi dng thuc nhm thc y
vic k n, s dng thuc. 4. Li dng s ng k cho php lu hnh thuc ca Cc Qun
l dc, ca c quan qun l dc phm nc khc qung co thuc
5. S dng danh ngha, biu tng, hnh nh, a v, uy tn, th tn ca t chc
y, dc, ca cn b y t, th cm n ca bnh nhn qung co, khuyn dng thuc.6.
Li dng hnh thc thy thuc hng dn cch phng bnh, cha bnh hoc hng dn s
dng thuc bng cc bi vit trn bo, bng cc chng trnh pht thanh, truyn
hnh qung co thuc.7. S dng cc loi kt qu nghin cu lm sng cha c s khoa
hc, cha bng chng y hc qung co thuc.8. Li dng kt qu kim nghim, cc
chng nhn do c quan c thm quyn cp, huy chng do hi ch trin lm cp cho
sn phm v/hoc n v qung co thuc.9.Q ung co thuc c ni dung khng ph hp
vi thun phong, m tc Vit Nam; lm dng hnh nh ng vt hoc cc hnh nh khc
khng lin quan thng tin, qung co thuc gy ra cch hiu sai cho ngi s
dng.
10. Pht hnh cho cng chng ti liu thng tin thuc cho cn b y t.11.
Dng cu, ch, hnh nh, m thanh gy nn cc n tng kiu sau y cho cng
chng:Thuc ny l s 1, l tt hn tt c.S dng thuc ny l bin php tt nht.S
dng thuc ny khng cn c kin ca thy thuc.Thuc ny hon ton v hi, khng c
tc dng ph, khng c chng ch nh.12. So snh vi qung co thuc ca mnh tt
hn thuc, hng ho ca t chc, c nhn khc.13. Qung co cc thuc cha c cp s
ng k hoc s ng k ht hiu lc.14. Qung co thuc khi:cha np h s ng k thng
tin, qung co thuc ti c quan qun l nh nc c thm quyn.qung co thuc
khng ng vi ni dung ng k. qung co thuc ang trong thi hn xem xt, gii
quyt h s theo quy nh.
Thuc thuc Danh mc thuc khng k n do B Y t ban hnh v c s ng k ang
cn hiu lc c qung co trn :sch, bo, tp ch, t ribo in t, website ca
doanh nghip, website ca n v lm dch v qung co pano, p phch bng rn,
vt th pht quang, vt th trn khng, di nc, phng tin giao thng, vt th
di ng khc v trn cc phng tin qung co khc( tr pht thanh, truyn
hnh).2. Thuc c B Y t cp s ng k lu hnh ti Vit Nam, c hot cht chnh nm
trong danh mc hot cht thuc c ng k qung co trn pht thanh, truyn hnh
do B Y t ban hnh c qung co trn pht thanh, truyn hnh.
3. Danh mc hot cht thuc v dc liu c ng k qung co trn pht thanh,
truyn hnh do B Y t ban hnh theo Thng t 42/2010/TT-BYT.224 thnh phn
hot cht thuc ha dc Cc dc liu khng c c tnh v/hoc khng c nhng tc dng
c hi nghim trng c bit hoc khuyn co c ng k qung co cho cng chng trn
pht thanh, truyn hnh.Cc dc liu c c tnh (v d : m tin, u, l ngn, trc
o, hong nn) s c xem xt trong tng thuc c th.Cc thuc ng y, thuc c
ngun gc t dc liu c cha dc liu c c tnh c xem xt theo nguyn tc : Cc
thuc ng y, thuc c ngun gc t dc liu c B Y t cp s ng k lu hnh c ng k
qung co trn pht thanh, truyn hnh vi tc dng, ch nh duyt v ph hp cc
quy nh ca Thng t hng dn hot ng thng tin qung co thuc do B Y t ban
hnh
Qung co trn sch, bo, tp ch, t ri, p phch.Qung co trn bng, bin,
pano, bng rn, vt th pht quang, vt th trn khng, di nc, phng tin giao
thng, vt th di ng khc. Qung co trn phng tin pht thanh, truyn
hnh.Qung co trn bo in t, website ca doanh nghip, website ca n v lm
dch v qung co.Qung co trn cc phng tin thng tin qung co khc
Ni dung qung co thuc phi ph hp vi cc ti liu sau y:T hng dn s dng
thuc c B Y t (Cc Qun l dc) ph duyt.Chuyn lun v thuc c ghi trong Dc
th Quc gia hoc trong cc ti liu v thuc c quc t cng nhn.
2. Qung co thuc trn sch, bo, tp ch, bng rn, phng tin giao thng,
vt th pht quang.Phi c cc thng tin sau:Tn thuc: l tn trong quyt nh
cp s ng k lu hnh ti Vit NamThnh phn hot cht:i vi thuc tn dc: Dng tn
theo danh php quc t.i vi thuc c ngun gc dc liu: Dng tn theo ting
Vit (tr tn dc liu Vit Nam cha c th dng theo tn nguyn bn nc xut x km
tn Latinh).
c) Ch nh.d) Cch dng.) Liu dng.e) Chng ch nh v/hoc nhng khuyn co
cho cc i tng c bit nh ph n c thai, ngi ang cho con b, tr em, ngi
gi, ngi mc bnh mn tnh.g) Tc dng ph v phn ng c hi.
2. Qung co thuc trn sch, bo, tp ch, bng rn, phng tin giao thng,
vt th pht quang.
h) Nhng iu cn trnh, lu khi s dng thuc.i) Tn, a ch ca c s sn xut
thuc. (C th thm tn, a ch nh phn phi).k) Li dn "c k hng dn s dng trc
khi dng".l) Cui trang u ca ti liu qung co thuc phi in:S Giy tip nhn
h s ng k qung co thuc ca Cc Qun l dc: XXXX/XX/QLD-TT, ngy ... thng
... nm.Ngy ... thng ... nm ... in ti liu.i vi nhng ti liu gm nhiu
trang phi nh s trang, trang u phi ghi r ti liu ny c bao nhiu trang,
phn thng tin chi tit v sn phm xem trang no.
2. Qung co thuc trn sch, bo, tp ch, bng rn, phng tin giao thng,
vt th pht quang.
3. QC trn pht thanh, truyn hnha) Thuc c cc iu kin sau y c qung
co trn pht thanh, truyn hnh: C hot cht chnh nm trong Danh mc hot
cht thuc c ng k qung co trn pht thanh, truyn hnh. Trong thnh phn ca
thuc khng c hot cht nm trong danh mc thuc( theo quy ch hin hnh): gy
nghin thuc hng tm thn tin chtthuc phng x b) Danh mc cc hot cht thuc
c ng k qung co trn pht thanh, truyn hnh do B trng B Y t ban hnh.
Danh mc ny c cp nht b sung, iu chnh cho ph hp.
c) Ni dung qung co thuc phi p ng thng tin:Tn thucThnh phn hot
chtCh nhChng ch nh, khuyn co cho cc i tng c bitTn, a ch c s sx( c
them tn, a ch nh phn phi)Li dn c k hng dn s dng trc khi dng. Mt s
quy nh trn phi c to r rng.Nu thnh phn thuc c t 03 hot cht tr ln th
tu theo thi lng pht sng, c th c hot cht chnh hoc c tn chung cc
vitamin, khong cht, dc liu.d) Trng hp n v mun qung co trn i pht
thanh, truyn hnh a phng th phi thng bo cho S Y t s ti bng vn bn km
theo Giy tip nhn h s ng k qung co thuc ca Cc Qun l dc v ni dung
qung co hoc kch bn c ng du xc nhn ca Cc Qun l dc.3. QC trn pht
thanh, truyn hnh
4. QC trn bo in t, website doanh nghip,n v lm dch v QC
n v kinh doanh thuc ch c qung co thuc m n v kinh doanh trn
website hp php ca mnh. Khng c php qung co thuc m mnh khng kinh
doanh.
b) n v kinh doanh thuc hoc n v c y quyn ch c qung co thuc trn
website ca n v lm dch v qung co khi n v lm dch v qung co c giy php
cung cp dch v thng tin Internet (ICP) ca B Thng tin v Truyn thng v
giy chng nhn ng k kinh doanh dch v qung co theo quy nh ca php
lut.
4. QC trn bo in t, website doanh nghip,n v lm dch v QC
c) Vic qung co thuc trn bo in t, website ca doanh nghip, website
ca n v lm dch v qung co phi thc hin mt chuyn mc ring. Chuyn mc ny
phi ghi r: Trang dnh ring cho qung co thuc v dng ch ny phi in m vi
c ch to hn c ch bnh thng v lin tc xut hin u trang.d) Ni dung qung
co trn bo in t, website ca doanh nghip, website ca n v lm dch v
qung co:Qung co thuc trn website phi p ng quy nh v ni dung qung
co.Vic qung co thuc di hnh thc ny phi ring bit, khng c qung co chng
cho hoc xen k nhiu thuc cng mt thi im trnh hiu lm.Qung co thuc trn
website di dng videoclip phi p ng quy nh ca qung co thuc trn pht
thanh v truyn hnh.
4. QC trn bo in t, website doanh nghip,n v lm dch v QC
e) Cc n v c cp Giy tip nhn h s ng k qung co thuc theo cc hnh thc
quy nh theo cc iu khon ti thng t s 13/2009/BYT:Tn thuc: l tn trong
quyt nh cp s ng k lu hnh ti Vit Nam.Thnh phn hot cht:i vi thuc tn
dc: Dng tn theo danh php quc t;i vi thuc c ngun gc dc liu: Dng tn
theo ting Vit (tr tn dc liu Vit Nam cha c th dng theo tn nguyn bn
nc xut x km tn Latinh).Ch nh.Chng ch nh v/hoc nhng khuyn co cho cc
i tng c bit nh ph n c thai, ngi ang cho con b, tr em, ngi gi, ngi
mc bnh mn tnh.Tn, a ch c s sx( c thm tn, a ch nh phn phi)Li dn "c k
hng dn s dng trc khi dng". th c th s dng ni dung qung co c chp thun
qung co trn Website, ng vi ni dung qung co ng k vi Cc Qun l dc.
5. Qung co thuc trn phng tin qung co khc
Cc n v ch c qung co thuc trn cc phng tin qung co khc khi phng
tin chuyn ti ni dung thng tin:Tn thuc: l tn trong quyt nh cp s ng k
lu hnh ti Vit Nam.Thnh phn hot cht:i vi thuc tn dc: Dng tn theo
danh php quc t;i vi thuc c ngun gc dc liu: Dng tn theo ting Vit (tr
tn dc liu Vit Nam cha c th dng theo tn nguyn bn nc xut x km tn
Latinh).4. Ch nh.Chng ch nh v/hoc nhng khuyn co cho cc i tng c bit
nh ph n c thai, ngi ang cho con b, tr em, ngi gi, ngi mc bnh mn
tnh.Tn, a ch c s sx( c thm tn, a ch nh phn phi)Li dn "c k hng dn s
dng trc khi dng". phi tun theo cc quy nh hin hnh c lin quan
6. Cc ch nh khng c a vo ni dung qung co thucCh nh iu tr: bnh
lao, bnh phong.2. bnh ly qua ng tnh dc.chng mt ng kinh nin. bnh ung
th, bnh khi u. bnh i tho ng hoc cc bnh ri lon chuyn ho khc tng t.
bnh vim gan do vi rt, cc bnh l mi niCc ch nh mang tnh kch dc
7. Cc thng tin, hnh nh khng c s dng trong qung co thuc
a) Hnh nh ngi bnh.b) S tc dng ca thuc m cha c nghin cu, nh gi.c)
Hnh nh, tn ca thy thuc gii thiu thuc.d) M t qu mc tnh trng bnh l
hoc cng dng ca thuc.) Hnh nh ng vt, thc vt trong danh mc cn bo
tn.e) Thng tin, hnh nh to ra cch hiu:s dng thuc ny khng cn c kin ca
thy thuc. s dng thuc ny hon ton v hi, khng c tc dng ph, khng c chng
ch nh, bo m 100% hiu qu.
1.C quan tip nhn, gii quyt h s qung co thuc B Y t (Cc Qun l dc):
Tip nhn, gii quyt h s ng k qung co thuc v h s ng k thng tin gii
thiu thuc cho cn b y t.S Y t: Tip nhn v gii quyt h s ng k hi tho
gii thiu thuc cho cn b y t v cp th cho Ngi gii thiu thuc.
2.H s, trnh t th tc gii quyt h s ng k qung co thuc
Cc n v trc khi qung co thuc phi gi h s ng k qung co thuc v B Y t
(Cc Qun l dc). H s ng k gm:a) Giy ng k qung co thuc (km theo mu).b)
Hnh thc, ni dung qung co thuc d kin.c) Ti liu tham kho, xc minh ni
dung qung co.d) Bn sao T hng dn s dng thuc c Cc Qun l dc duyt;) Bn
sao Giy php lu hnh sn phm do Cc Qun l dc cp hoc bn sao Quyt nh cp s
ng k thuc ca Cc Qun l dc.e) Bn sao Giy chng nhn iu kin kinh doanh
thuc hoc giy php hot ng cng ty nc ngoi ti Vit Nam.g) Nu qung co trn
pht thanh, truyn hnh phi gi kch bn, bng hnh, bng ting. Kch bn phi m
t r phn hnh nh, phn li, phn nhc.
2. H s, trnh t th tc gii quyt h s ng k qung co thuc
Ton b cc ti liu c trong h s phi ng du gip lai ca n v lp h s. Cc
ti liu quy nh ti cc im d, v e trn ch cn bn photocopy v ng du ca n v
ng k qung co.
Ni dung d kin qung co hoc kch bn m t phi np 02 bn. Sau khi hon
chnh, 01 bn s c lu ti c quan qun l, 01 bn c ng du xc nhn ca Cc Qun
l dc v giao cho n v ng k qung co.
Cc Qun l dc s khng xem xt ni dung ng k qung co khng lin quan n
thuc quy nh trong danh mc ca thng t s 42/2010/BYT.
2. H s, trnh t th tc gii quyt h s ng k qung co thuc
Khi nhn c h s ng k y , hp l theo ng quy nh Cc Qun l dc s gi cho
n v np h s mt Giy tip nhn h s (theo mu nh km). Ngy ghi trn giy tip
nhn h s l ngy Cc Qun l dc nhn h s hp l. Sau 10 ngy lm vic, k t ngy
ghi trn Giy tip nhn, nu Cc Qun l dc khng c cng vn yu cu sa i, b
sung th n v c quyn thng tin, qung co nh ni dung ng k.Trng hp h s ng
k qung co thuc cha y , hp l theo ng quy nh trong vng 10 ngy lm vic,
Cc Qun l dc c cng vn thng bo cho n v ng k qung co thuc b sung, hon
chnh h s.
2. H s, trnh t th tc gii quyt h s ng k qung co thuc
Trng hp Cc Qun l dc c cng vn yu cu sa i, b sung:Trong cng vn yu
cu sa i, b sung phi nu c th, chi tit: B sung thm nhng ti liu no, sa
i ni dung g, b sung thm ni dung no.
b) n v phi sa i, b sung theo ng nhng ni dung c nu trong cng vn
yu cu sa i, b sung v gi v Cc Qun l dc ni dung qung co c sa i, b
sung. Khi n v sa i, b sung ng theo yu cu, Cc Qun l dc gi n v mt Giy
tip nhn h s, ngy ghi trn giy tip nhn h s l ngy Cc Qun l dc nhn c h
s b sung. Sau 10 ngy lm vic, k t ngy nhn c ni dung qung co sa i, b
sung nu Cc Qun l dc khng c cng vn yu cu sa i, b sung th n v c qung
co nh ni dung sa i.
c) Trong thi gian 03 thng k t ngy Cc Qun l dc c cng vn yu cu b
sung, sa i, nu n v ng k qung co khng sa i, b sung h s th h s khng
cn gi tr.
2.H s, trnh t th tc gii quyt h s ng k qung co thuc
Trnh t ng k v thm nh h s qung co c thm nh h s c thc hin li t u
trong cc trng hp:n v qung co thuc phi sa i, b sung nhng khng theo
ng nhng ni dung c nu trong cng vn yu cu sa i Ni dung qung co ng k
ti Cc Qun l dc v c Giy tip nhn nhng n v qung co khng tun th cc hnh
vi nghim cm ban hnh.Trong cc trng hp ny, Cc Qun l dc s c cng vn
thng bo cho n v ng k qung co khng c qung co theo ni dung ng k.
2. H s, trnh t th tc gii quyt h s ng k qung co thuc
Trng hp n v c h s ng k qung co thuc khng tun th quy nh th Cc Qun
l dc s c cng vn cnh bo n v v dng tip nhn, xem xt h s ng k qung co
thuc ca n v t 3- 12 thng trong tng trng hp c th nh sau :
a) Dng tip nhn, xem xt h s ng k qung co thuc ca n v 3 thng i vi
trng hp khng tun th qung co thuc khi:cha np h s ng k qung co thuc
ti c quan qun l nh nc c thm quyn.qung co thuc khng ng vi ni dung ng
k.qung co thuc ang trong thi hn xem xt, gii quyt h s theo quy
nh.
2. H s, trnh t th tc gii quyt h s ng k qung co thuc
b) Dng tip nhn, xem xt h s ng k thng tin, qung co thuc ca n v t
3 n 6 thng i vi trng hp khng tun th theo quy nh khon 14 iu 5 ca
Thng t 13/2009/BYT 2 ln trong mt nm.c) Dng tip nhn, xem xt h s ng k
thng tin, qung co thuc ca n v t 6 n 12 thng i vi trng hp khng tun
th theo quy nh ca Thng t s 13/2009/BYT t 3 ln tr ln trong mt nm.
Ngoi cc hnh thc trn, Cc Qun l dc s cng khai ni dung vi phm ca n v
trn website ca Cc Qun l dc; thng bo ti c quan Thanh tra v cc c quan
chc nng c thm quyn xem xt, x l theo quy nh ca php lut.
3. Hiu lc ca ti liu qung co thuc
Ti liu qung co thuc ng k ti Cc Qun l dc ht gi tr trong cc trng
hp sau y: Thuc c s ng k ht hn.Thuc b rt s ng k hoc thuc b c quan
qun l nh nc c thm quyn khuyn co hn ch s dng. C nhng thay i v thng
tin i vi thuc.
1. Cc Qun l dc, Thanh tra B Y t t chc kim tra, thanh tra vic thc
hin Thng t s 13/2009/BYT theo thm quyn i vi cc n v, c nhn c lin
quan n hot ng qung co thuc trn lnh th Vit Nam.2. S Y t cc tnh, thnh
ph trc thuc Trung ng chu trch nhim kim tra, thanh tra vic thc hin
cc Thng t quy nh trong phm vi a phng mnh qun l.
1. n v, c nhn vi phm ty theo mc s b x pht hnh chnh hoc nh ch vic
qung co hoc rt s ng k mt hng thuc vi phm hoc b truy cu trch nhim
hnh s theo quy nh ca php lut.2. n v, c nhn c quyn khiu ni, t co v
hot ng thng tin, qung co theo quy nh ca php lut v khiu ni, t
co.
B. S khc nhau v quy nh qung co gia Vit Nam v Hoa K, Anh, Trung
Quc
im khc nhauVit Nam Hoa KCc thuc c qung coCh c qung co cc thuc
khng k n theo danh sch m B Y T quy nh. (OTC)Qung co c c thuc k n
hoc thuc khng k n(OTC):- FDA gim st qung co cho thuc k n- y ban
Thng mi Lin bang (FTC) gim st qung co cho thuc khng k n (OTC) qun l
t nghim ngc hn so vi thuc k n.So snh sn phm thuc
ca mnh vi mt hng
ha ca t chc, c nhn
khcNghim cm so snh vi
qung co thuc ca
mnh tt hn thuc, hng
ha ca t chc, c nhn
khcCho php so snh sn phm thuc ca mnh so vi sn phm t chc, c nhn
khc nhng phi chnh xc v ng s tht v c bng chng minh.
I. S khc nhau v quy nh qung co thuc ti Vit Nam so vi Hoa K
im khc nhauVit NamHoa kQuy nh cc thuc khng c qung coCc thuc k
nCc thuc c ni dung ch nh iu tr bnh lao, phongiu tr bnh ly qua ng
tnh dciu tr chng mt ng kinh nin.C mang tnh kch dc C iu tr ung th,
bnh khi uC iu tr bnh T v cc bnh ri lon chuyn ha khc tng tNgoi ra
qung co trn truyn hnh nghim cm qung co thucC hot cht chnh nm trong
danh mc hot cht thuc c ng k qung co trn pht thanh truyn hnh V trong
thnh phn thuc khng c hot cht nm trong danh mc thuc gy nghin, danh
mc hng tm thn, danh mc tin cht, danh mc thuc phng x theo quy ch hin
hnh Khng c quy nh
I. S khc nhau v quy nh qung co thuc ti Vit Nam so vi Hoa K
Khc nhauVit NamHoa kCc hnh thc qung co thuc.Khng c phn loi cc
loi qung co nh Hoa KGm 3 hnh thc qung co thucHelp-Seeking
Advertisements Qung co tm kim gp l mt qung co m t mt bnh ,qung co
ny khuyn khch bnh nhn b bnh ny lin h bc s c thm thng tin. Khng c
ngh hay khuyn s dng sn phm thuc no.Reminder Advertisements qung co
nhc nh cho tn mt loi thucKhng cp n li ch hay ri ro hay cng dng ca
thucLoi ny khng c qung co i vi cc lai thuc k toa c nhng tc dng khng
mong mun nghim trng do FDA quy nh.Product Claim Advertisements qung
co tuyn b sn phm l qung co cn c s cn bng v thng tin v tc dng khng
mong mun ca thuc so vi nhng thng tin v cng dng ca thuc.=>loi
qung co ny c quy nh gn ging vi qui inh qung co thuc Vit Nam
I. S khc nhau v quy nh qung co thuc ti Vit Nam so vi Hoa K
im khc nhauVit NamHoa KMt s ni dung quy nh trong qung co trn pht
thanh, truyn hnh.(gia qung co thuc ti Vit Nam v Product Claim
Advertisements qung co tuyn b sn phm ca Hoa KKhng c quy nh
Khng c quy nh
Tn, a ch c s sn xut
Phi c thng tin tc khng mong mun nghim trng nht c th c ca thuc,
(c th thng tin v cch gim bt cc tc dng khng mong mun )
Phi lit k tt c cc tc dng khng mong mun ca thuc hoccc ngun thng
tin v a ch ngi xem tm ccthng tin v s dng thuc Khng c quy nh
I.S khc nhau v quy nh qung co thuc ti Vit Nam so vi Hoa K
im khc nhauVit Nam Hoa KXt duyt ti liu qung co trc khi cho php
qung co mt sn phm thucPhi np h s ng k qung co ti cc Qun l dc xt
duyt h s mi c php qung co .Khng xem xt, xt duyt trc khi qung co mt
thuc. Ch c vi trng hp c bit phi c FDA xt duyt mi c php qung coQung
co khng ng i tng ch nh iu tr thucKhng c quy nhQung co m khng ng i
tng trong ch nh iu tr ca thuc l vi phm
I. S khc nhau v quy nh qung co thuc ti Vit Nam so vi Hoa K
II. S khc nhau quy nh qung co thuc gia Vit Nam v nc Anhim khc
nhauVit NamAnh Cc thuc c qung coCh c qung co cc thuc khng k n theo
danh sch m B Y T quy nh.Khng c qung co thuc gy nghin, hng tm
thn.Qung co thuc k n, thuc khng k n, mt s thuc gy nghin theo cng c
thuc gy nghin 1961( acetyl dihydro codein, codein, dihydro codein,
ethyl morphin, nico dicodin, norcodein, pholcodin).Cc thuc khng c
qung coKhng qung co thuc k n trn mi hnh thc.Qung co thuc k n trn tp
ch hay ng ti trn internet th phi ghi r i tng c v gii hn tm kim cho
i tng l cn b,chuyn gia chm sc sc khe .
Cc thuc qung co c gim stKhng c cpVi qung co thuc gim au(
aspirin, paracetamol, ibuprofen) th MHRA s gim st cc chng trnh
khuyn mi thuc trnh gy qu liu dn n ng c. Cc thuc ny c khuyn khch bn
l.
im khc nhauVit NamAnh Quy nh qung co thuc cho ph n mang thaiKhng
cQung co cho ph n mang thai :Thuc c ch dn c th s dng thuc, y thng
tin v thuc th c th c qung co s dng trong thi k mang thai; cn thuc
khng c ch dn c th s dng thuc th khng c ly hnh nh ph n c thai qung
co.Qung co khng nn truyn ti thng ip rng n l bnh thng, khng gy hi i
vi ph n mang thai v s pht trin thai nhi khi dng thuc m phi phn nh
tc dng c hi ca thuc c th ln cc giai on pht trin ca thai k v cn phi
c thng ip vi cc thuc s dng cho ph n c thai: cn thn k n thuc cho
PNCT v thuc c th i qua nhau thai, nh hng n thai nhi. Cc nh qung co
a ra s khuyn khch t vn v cc bin php khng dng thuc thch hp v cn tham
kho kin ca bc s, chuyn gia sc khe khi dng sn phm dnh cho ph n c
thai.
II. S khc nhau quy nh qung co thuc gia Vit Nam v nc Anh
im khc nhauVit Nam AnhQuy nh qung co thuc ph thaiKhng c quy
nhKhng qung co cc sn phm ph thai
Thi gian lu h s qung coThi gian lu tr h s l 5 nm.Thi gian lu tr
h s khiu ni l khng c th.Thi gian lu tr h s qung co ti c quan thm
quyn l 3 nm. V lu tr h s khiu ni t co vi phm l 7 nm.
II. S khc nhau quy nh qung co thuc gia Vit Nam v nc Anh
Vit NamAnh Cc thng tin cha y trn qung co th c y c th cc thng tin
trong t hng dn s dng thuc khi mua thuc.Cc qung co cha y thng tin
cho cng chng th c b sung mt trang khc dnh cho cng chng ch cng khai,
mi ngi khng truy cp vo phn dnh cho cn b chuyn gia chm sc sc
khe.Qung co trn sch, bo, tp ch, pht thanh truyn hnh, website v cc
phng tin khc.Ch qung co thuc cho cng chng trn phng tin internet v
cc thit b k thut s v nghim cm qung co trn cc phng tin khc.Qung co
khng cha ni dung gi thnh sn phm.Gi thnh sn phm cng c bo co trong ni
dung qung co.Khng cQung co m khng ng i tng trong ch nh iu tr ca
thuc l vi phm( v d: mt qung co trong miu t mt em b m thuc khng ch
nh tui di 2tui th s vi phm quy nh).
II.S khc nhau quy nh qung co thuc gia Vit Nam v nc Anh
III. Nhng quy nh qung co thuc v cc dch v y t ca Trung qucDc phm
c bit nh thuc gy nghin, thuc hng thn, c t tr liu v thuc phng x, tin
cht ha hc i vi thuc, cng nh cc loi thuc, dng c y t v cc liu php c s
dng trong iu tr cai nghin ma ty, khng c qung coQung co thuc OTC
khng cn nu r c ch tc dng dc l ca chngThuc, thit b v cc dch v y t
khng nn c qung co qua ngi chuyn nhngV qung co trn Internet, qung co
email khng c gi n ngi tiu dng m cha c s cho php .Bt k qung co in t
lu thng phi xc nh r ngi gi v ngi nhn c c hi tr hoc khc t sn phmQung
co dch v y t cha nhng thng tin c bn lin quan n cc c s y t qung co,
chng hn nh tn, a ch, s in thoi, i tng lm sng v s ging.Qung co thuc
v thit b yu cu phi ph chun trc bi FDAs a phng Trung Quc.Qung co
thuc theo n phi t trn cc tp ch y t v dc phm c nhm mc tiu l cc chuyn
gia chm sc sc khe. Trung Quc cng nghim cm qung co so snh.Dc v thit
b sn xut khng th so snh v tnh hiu qu v an ton ca cc sn phm vi mt sn
phm cnh tranh.Qung co khng c lm nh hng n sc khe th cht v tinh thn
ca tr v thnh nin hoc ngi tn tt.
Ti liu tham
khohttps://www.gov.uk/guidance/advertise-your-medicines#advertise-to-prescribers-and-suppliers-of-medicineshttp://www.fda.gov/Drugs/ResourcesForYou/Consumers/PrescriptionDrugAdvertising/ucm076768.htmhttps://www.gov.uk/government/uploads/system/uploads/attachment_data/file/376398/Blue_Guide.pdfThng
t v ni dung qung co sn phm:
http://thuvienphapluat.vn/van-ban/Thuong-mai/Thong-tu-09-2015-TT-BYT-xac-nhan-noi-dung-quang-cao-san-pham-hang-hoa-dich-vu-quan-ly-cua-Bo-Y-te-275518.aspxDanh
mc thuc v dc liu c qung co
http://www.moj.gov.vn/vbpq/Lists/Vn%20bn%20php%20lut/View_Detail.aspx?ItemID=26218
thng t quy nh v hng dn hot ng thng tin qung co thuc :
http://moj.gov.vn/vbpq/lists/vn%20bn%20php%20lut/view_detail.aspx?itemid=23679
