COINC IK)A XA HOI C HU NGHIA VIF I NAM Doc lap - I n do - Hanh phuc

BO Y TIECUC AN I OAN THUG PHAM

Sd^^'KL-ATTP Ha Npi, ngayjAthansflJncwn 2020

KET LUAN THANH TRA> • A y r r\ A y AVe vice thanh tra vice chap hanh phap In at vc an loan thne pliam trong san xuat, kinh doanh, nhap khan, qnang cao thne pham

bao ve she khoe tai tinh Ben Ti e va Tien Ciang

Thirc hien Quyet dinh thanh tra so 1006/QD-ATTP nga> 11/1 1/2019 cua

Cue truong Cue An loan thire pham ve vice thanh tra vice ehap hanh eae c]u\ dinh phap luat trong san xuat. kinh doanh. nhap khau. quang eao san pham llurc

pham bao ve sue khoe tren dja ban tmh Ben Ire va lien (iiang. tu nga\ 19/1 1/2019 den 10/01/2020, Doan thanh tra da tien hanh thanh tra tai 02 eo- so' tai tinh Ben Ire va 03 co so tai tinh Tien (iiang (gbm thdi gian thanh tra tai eo

so. kiem tra xac minh ho so1 eua eo so dupe thanh tra tai tru so eo' quan. kiem

nghiem 13 man lay tai eo so dupe thanh tra, thdi gian Chi eue An Loan ve sinh

thue pham Ben Tre xae minh hang hda \ i pham. ban hanh Quyet dinh \u phat \ i pham hanh ehinh ddi vdi eo so vi pham).

Xet bao cao ket qua thanh tra nga> 30/01/2020 eua I nrong doan thanh

tra. y kien giai trinh cua ddi tirpng thanh tra. Cue tru’dng Cue An loan thue pham

ket luan nhir sau:

I. Khai quat dac diem tinh hinh to clnVc, boat dong cd lien quan den

npi dung thanh tra ciia 05 co' so la ddi tupng thanh tra

1. Cong ty TNHH Mot thanh vien Hien Hai Phat, dja chi: So 691/1, dudngsd 1, khu Phd My Tan, phudng 7, thanh phd Ben Tre, tmh Ben I re

Gidy ehiing nhan dang ky doanh nghiep Ma so doanh nghiep: 1300986642, dang ky lan dau ngay 29 thang 05 nam 2015. dang ky tha\ ddi lan

thir 1. ngay 25/12/2015 do Phong Dang ky kinh doanh eua So Ke hoach va Dau

tu tinh Ben I re cap.

l ong so san pham thue pham bao vc sue khoe do eo so cong bd tai Cue

An loan thue pham: 12 hd so edng bd eon hieu lire.

2. Cong ty cd phan Sa Sam Viet, dja chi: So 430C1 NguytMi Hue, Phudng Phti Khuong, thanh phd Bimi Tre, tinh Ben Tre

Giay ehung nhan dang ky doanh nghiep Ma so doanh nghiep: 1301015435, dang ky lan dau ngay 06 thang 09 nam 2016. dang ky lha\ ddi lan

tlur 5. ngay 22/07/2019 do Phong Dang ky kinh doanh ciia So Kc hoach \a Dau

tir tinh Ben Tre cap.

l ong so san pham tlurc pham hao ve sire khde eo so eong ho san pham: 08 san pham ho so eong bo con hieu lire.

3. Cong ty Co phan Dime pham TIPHARCO, dja chi: Ld 08 - 09 C um

Cong Nghiep va Ticu thii Cong Nghiep I an My Chanh, Phudng 9, Ihanh phd My Tho, tinh Tien Giang.

Giay chirng nhan dang ky doanh nghiep eong ty eo phan so 1200100557

dang ky lan dau ngay 28/02/2006. Dang ky tha> doi lan thir 14 nga\ 27/04 2018 do Phong Dang ky kinh doanh ciia So Ke hoach va Dau tir tinh Tien Ciiang cap.

Tong so san pham tlurc pham bao ve sire khoe do eo' so' eong bo tai Cue An loan tlurc pham: 20 san pham ho so- eong ho eon hieu lire.

4. Cong ty Co phan Thien Nhien Viet, ilia chi tru so chinh: So 1 15 Qudc lo 50, Ap Phong Thuan, Xa Tan My Chanh, thanh phd My I ho, tinh Tien Giang. Dja chi Chi nluinh Cong ty - noi dang k\ co so san

xuat: Ap Long Hda, Xa Dao I hanh, I hanh phd My I ho, I ien (»iang

Giay chirng nhan dang ky doanh nghiep eong t) eo phan so 1200725654

dang ky lan dau ngay 31/07/2008. Dang ky thay doi lan thir 10 ngay 07/10/2014

do Phong Dang ky kinh doanh - So Ke hoach va Dau tir tinh Tien Giang cap.

Tong so san pham tlurc pham bao ve sire khoe do eo so eong bd tai Cue

An loan tlurc pham: 13 san pham ho so eong bd con hieu lire.r r

5. Co' so san xuat Dong Nam Dime Ngoc Lien, dja chi: 127/9 Le I hi Hong Gam, Phudng 6, thanh Phd My Tho, tinh T ien Ciiang

Giay chirng nhan dang ky hd kinh doanh so 53A8022429 dang k\ lan dau

ngay 12/08/2011. Dang ky thay doi lan thir 02 nga\ 1 1 6 2018 do Phong Tai chinh - Ke hoach thude Uy ban nhan dan I hanh phd M\ 1 ho cap.

Tong so san pham tlurc pham chtrc nang/ tlurc pham bao \e sire khoe eo so eong bd: 09 san pham hd so edng bd con hieu lire.

r v

II. Ket qua kiem tra, xac minh

1. Cong ty TNHH Mot thanh vien HiC‘n llai Phat, dja chi: SO 69L1, dudng so 1, khu Phd My Tan, phudng 7, thanh phd Ben Tre, tinh Ben I re

(1) Cong hd san pham:

Tai thdi diem thanh tra, Giam doe Cong ty bao eao. Cong l\ edng bd 12

san pham tlurc pham bao ve sire khoe. cac hd so1 edng bd eon hieu lire, eu the:

- Tlurc pham bao ve sire khoe Sim PF.PT1NF-H. Giay xac nhan cong bo

plui hop quy dinh an loan tlurc pham so 10163/2017/ATTP-XNCR ngav

05/4/2017.

- Tlurc pham bao ve sire khoe BEST GLUCO-ll, Gia\ xae nhan eong bo

phu hop quy dinh an loan tlurc pham so 10164/2017/A 1 I P-XNCB nga\ 05/4/2017.

- Thire pham bao ve sire khoe GOOD BRAIN-H. Giay xae nhan eong bo

phu hop quy dinh an loan thire pham so 10162/2017/ATTP-XNCB nga\ 05/4/2017.

- Thire pham bao ve sire khoe dai trang GOOD -11, Giay xae nhan eong bo phu hop quy dinh an loan thire pham so 10159/2017/ATTP-XNCB ngav

05/4/2017.

- Thire pham bao ve sire khoe Vien xuong khop khuan Hoa - IT Gia\ xae nhan eong bo phu hop quy dinh an loan thire pham so 10161/2017 A 1 1 P- XNCB ngav 05/4/2017.

- 'Thire pham bao ve sire khoe CURMIN GOI D. Gifo tiep nhan dang k\ ban eong b6 s6 2147/2018/DKSP ngav 02/5/2018.

- Thire pham bao ve sue khoe 1TEMO VEIN 11 NHAt TAM. Gia\ tiep

nhan dang ky ban eong bo so 2746/2018/DKSP ngav 21/5/2018.

- Thire pham bao ve sue khoe Calmax Pluss Nhat Tam. Giay tiep nhan

dang ky ban eong bo so 4290/201 8/DKSP ngay 1 2/7/201 8.

- Thire pham bao ve sue khoe Giai doe gan T-l T Giay tiep nhan dang k\ ban eong bo so 11875/2019/DKSP ngay 18/10/2019.

- Thire pham bao ve sue khoe SIRO EUC VI T-H. Giay tiep nhan dang ky ban eong b6 s6 1 1982/2019/DKSP ngay 22/10/2019.

- Mure pham bao ve sue khoe Sim Nhan Phue. Giay tiep nhan dang k\ ban eong b6 s6 1 1 874/2019/DKSP ngay 18/10/2019.

- Thire pham bao ve sue khoe Sim Yen Sao THYMO MK7 -I T Gia> tiep

nhan dang ky ban cong b6 s6 11873/2019/DKSP ngay ] 8/10/2019.

(2). Ghi nhan san pham: Doan lhanh tra danh gia ve ghi nhan eua 08

san pham tai kho Cong ty ghi nhan:

2.1 So san pham dirge kiem tra ve ghi nhan: 08 san pham

2.2 So san pham co nhan ghi dung qu\ dinh: 06 san pham

2.3 So san pham eo nhan ghi khong dung qu\ djnh: 02 san pham

Cu the:

- 02 san pham nhan khong phu hop voi eong bo la:

-I- Thuc pham bao ve sue khoe MEMO VEIN

010618, NSX 16/6/18, USD: 15/06/21: Noi dung ghi nhan khong plui hap \ ai nhan do Cong ty TNHH Mot thanh vien Hien Hai Phat cong ho diroc Cue An

loan llurc pham cap Giay tiep nhan dang kv ban cong bo so 2746/2018/DKSP

ngay 21/5/2018.

11 NI1A I PAM. 16 SX:

+ Thuc pham bao ve sire khoe Calmax Pluss Nhat l am. 16 SX: 180633. NSX 16/08/18. USD: 15/08/21: Noi dung ghi nhan khong phu hop voi nhan do

Cong ty TNI 111 Mot thanh vien I lien Hai Phat cong bo diroc Cue An loan llurc

pham cap Giay tiep nhan dang ky ban cong bo so 4290/2018/DKSP nga\ 12/7/2018.

- 06 san pham nhan phu hop voi cong bo la:

i Thirc pham bao ve sire khoe CURM1N GOED. 16 SX: 180458. NSX

26/05/18, USD: 25/05/21: Noi dung ghi nhan phu hop voi nhan do Cong ty

TNI 111 Mol thanh vien I lien Hai Phat cong bo diroc Cue An loan thirc pham cap

GiAy ti6p nhan dang ky ban cong b6 s6 2147/2018/DKSP ngay 02/5/2018.

+ Thirc pham bao ve sue khoe dai trang GOOD -El. 16 SX: 190154. NSX

16/03/19. USD: 15/03/22: Noi dung ghi nhan phu hop voi nhan do Cong t\ TNHH Mol thanh vien Mien Hai Phai cong bo diroc Cue An loan llurc pham capGiay xac nhan cong bo phu hop quy dinh an loan llurc pham so10159/2017/ATTP-XNCB ngay 05/4/2017.

+ Thirc pham bao ve sire khoe Siro PEP11NE-E1. 16 SX: 190133. NSX

18/03/19. USD: 17/03/22: Noi dung ghi nhan phu hop voi nhan do Cong l\ TNHE1 Mot thanh vien Mien Hai Phat cong bo diroc Cue An loan llurc pham cap

Gidy xac nhan cong bo phu hop qii)' dinh an loan thirc pham so10163/2017/ATTP-XNCB ngay 05/4/2017.

-i Thirc pham bao ve sue khoe BEST GE11CO-H. 16 SX: 180712. NSX

25/10/18. USD: 24/10/21: Noi dung ghi nhan phu hop voi nhan do Cong tv

T NHH Mol thanh vien Hien Hai Phat cong bo dupe Cue An loan llurc pham cap

Gmy xac nhan cong bo phu hop quy dinh an loan thirc pham so10164/2017/ATTP-XNCB ngay 05/4/2017.

i Thuc pham bao ve sue khoe Vien xirong khop Thuan 1 loa

180412, NSX 27/06/2019, USD: 26/06/2022: Noi dung ghi nhan phu hop voi nhan do Cong ty TNITH Mol thanh vien Hien Hai Phat cong bo dupe Cue An

loan thirc pham cap Giay xac nhan cong bo phu hop quy dinh an loan llurc pham

s6 10161/201 7/ATTP-XNCB ngay 05/4/201 7.

+ Thuc pham bao ve sue khoe GOOD BRA1N-H. 16 SX: 190516. NSX

29/06/19, USD: 28/06/22: Npi dung ghi nhan phu hop voi nhan do Cong ty

TNHH Mot thanh vien I licm Hai Phat cong bo dupe Cue An loan (hue pham cap

II. 16 SX:

Giay xac nhan cong bo phu hap qii_\ dinh an loan ihirc pham so

10162/2017/ATTP-XNCB ngay 05/4/2017.X V(3) . Dieu kien bao dam an toan thuc pham

Dieu kien kho bao quan cua Cong ty co ban dap irng dieu kien bao quan san pham thuc pham.

(4) . Quang cao san pham:

I heo bao cao cua Giam doc Cong tv. Cong ty khong co website. Cong indirge Cue An toan thuc pham cap Gia\ xac nhan ngi dung quang cao so

01457/201 8/ATTP-XNQC ngay 06/12/2018 cho san pham thuc pham bao ve

sue khoe MEMO VEIN II NHAT TAM. Tai thai diem thanh tra. Cong i\khong quang cao thuc pham bao ve sue khoe.

(5). Lay man kiem nghiem: Doan thanh tra lay man 07 san pham thuc

pham bao ve sue khoe. Ket qua kiem nghiem 07/07 man dal yen can (phieu

kiem nghiem s6 028089; 028090; 028091; 028092; 028093; 028094; 028095/PNK-YTCC ngay 18/12/2019 cua Vien Y lC; cong cong Thanh phb Mb

Chi Minh).

2. Cong ty co phan Sa Sam Viet, dia chi: So 430CI Nguyen Hue, Phuong Phu Khirong, thanh phb Ben I re, tinh Ben I re

(1) Ho so hanh chinli, phap ly ciia co so:

Giay chung nhan co so- dii dieu kien an loan ihuc so 000465/201 8 A 1 1 P- CNDK. ngay 01/8/2018 do Cue An toan thuc pham cap

(2) . Cong bo san pham:Tai thoi diem thanh tra. Giam doc Cong ly bao cao. Cong i\ cong bo 08

san pham thuc pham bao ve sue khoe. cac ho so- cong ho con hieu lire, cu ihe:

- Thuc pham bao ve sue khoe BeaulySAM. Giay tiep nhan dang kv ban

cong b6 s6 6375/2019/DKSP ngay 05/6/2019.

- Thuc pham bao ve sue khoe SulinSAM. Gia\ liep nhan dang k\ ban

cong bb sb 5659/2019/DKSP ngay 22/5/2019.

- I huc pham bao ve sue khoe LiverSAM. Gia_\ liep nhan dang k} ban

cong bb so 5661/2019/DKSP ngay 22 5/2019.

- Thuc pham bao ve sue khoe NeuroSAM. Giay tiep nhan dang k\ ban

cong bb sb 5660/2019/DKSP ngay 22/5/2019.

- Thuc pham bao ve sue khoe ColoSAM. Gia\ liep nhan dang ky ban

cong bb sb 5662/2019/DKSP ngay 22/5/2019.

- Thuc pham bao ve sue khoe PowerSAM. Giay tiep nhan dang ky ban

cong bb sb 6442/2019/DKSP ngay 05/6/2019.

- Tlurc pham bao ve sire khoe Bo.loSAM. (iia\ liep nlian dang k\ ban

cong bb sb 5658/2019/DKSP ngay 22/5/2019.

- Thuc pham bao ve sire khoe BronSAM, Gia\ liep nhan dang k\ ban

ebng bb sb 5663/2019/DKSP ngay 22/5/2019.

(3). Ghi nhan san pham: Doan thanh Ira danh gia ve ghi nhan eua 08

san pham tai kho Cong ty ghi nhan:

3.1 Sb san pham dirge kiem Ira ve ghi nhan: 08 san pham

3.2 Sb san pham co nhan ghi dung quy dinh: 08 san pham

3.3 Sb san pham co nhan ghi khbng dung qu_\ dinh: 0 san pham

Cu the 08 san pham nhan phu hop voi ebng bb la:

- Thuc pham bao ve sire khoe BeaulySAM. lb SX: 320519. NSX 090619. USD: 090622: Nbi dung ghi nhan phu hop voi nhan do Cong l> eb phan Sa

Sam Viet ebng bb dirge Cue An loan thire pham eap (iia_\ liep nhan dang k\ ban ebng bb sb 6375/2019/DKSP ngay 05/6/2019.

- Thire pham bao ve sire khoe SulinSAM. lb SX: 040619. NSX 020619. HSD: 020622: Nbi dung ghi nhan phu hop voi nhan do Cong is eb phan Sa

Sam Viet ebng bb dirge Cue An loan thire pham eap (lias liep nhan dang k\ ban ebng bb sb 5659/2019/DKSP ngas 22/5/2019.

- Thuc pham bao ve sire khoe LiverSAM. lb SX: 300519. NSX 300519. HSD: 300522: Nbi dung ghi nhan phu hop voi nhan do Cong ty eb phan Sa

Sam Viet ebng bb dirge Cue An loan thire pham eap Giay liep nhan dang k\ ban ebng bb sb 5661 /2019/DKSP ngas 22 5 2019.

- Tlurc pham bao ve sire khoe NeuroSAM. lb SX: 010619. NSX 310519. HSD: 310522: Nbi dung ghi nhan phu hop sbi nhan do Cong ts eb phan Sa

Sam Viet ebng bb dupe Cue An loan thire pham cap Giay liep nhan dang ks

ban ebng bb sb 5660/2019/DKSP ngay 22/5/2019.

- Thire pham bao ve sue khoe ColoSAM. lb SX: 030619. NSX 010619. HSD: 010622: Nbi dung ghi nhan phu hop sbi nhan do Cong t> eb phan Sa

Sam Viet ebng bb dirge Cue An loan thuc pham cap Giay liep nhan dang ks

ban ebng bb sb 5662/2019/DKSP ngay 22/5/20 19.

- Thire pham bao ve sue khoe PosverSAM. lb SX: 310519. NSX 080619. HSD: 080622: Nbi dung ghi nhan phii hgp vb'i nhan do Cong t> eb phan Sa

Sam Viet ebng bb dirge Cue An loan thire pham cap Gias liep nhan dang ks

ban ebng bb sb 6442/2019/DKSP ngas 05/6/2019.

6

- ['hire pham bao ve sire khoe BoJoSAM, 16 SX: 020619. NSX 310519. USD: 310522: Ngi dung ghi nhan phu hop voi nhan do Cong ty co phan Sa

Sam Viet eong bo dirge Cue An loan tlure pham eap (jia> liep nhan dang k\ ban eong bo s6 5658/2019/DKSP ngay 22/5/2019.

- Tlure pham bao ve sire khoe BronSAM. 16 SX: 290519 01. NSX

020619. HSD: 020622: N6i dung ghi nhan phu hop voi nhan do Cong ty eo

phan Sa Sam Viet eong bo dirge Chav tiep nhan dang ky ban eong ho so

5663/2019/DKSP ngay 22/5/2019.

(4) . Dieu kien bao dam an loan Ihuc pham

Dieu kien kho bao quan cua Cong ty dap irng dieu kien bao quan san

pham tlure pham.

(5) . Quang cao san pham:

T'heo bao eao eua Giam doe Cong ty. Cong ty eo website: sasamx iet.eom. hien nay eong ty dang trong qua trinh hoan thien ho so de giri ve (’tie An loan

tlure pham dang ky xac nhan ngi dung quang eao doi voi eae san pham tlure

pham bao ve sire khoe eua Cong ty. I lien tai Cong ty ehira tlure hien quang eao

tlure pham bao ve sire khoe.

Tai thoi diem thanh Ira. Doan lhanh tra ghi nhan website: sasann iet.eom

khong quang eao eae san pham tlure pham bao \e sire khoe eua Cong t\.

(6) . Lay man kiem nghiem: Doan thanh tra lay man 03 san pham tlure

pham bao ve sire khoe. Ket qua kiem nghiem 03/03 man dal yen eau (phieu

kiem nghiem s6 028096; 028097: 028098/PNK-YTCC nga\ 18/12/2019 eua

Vien Y te eong eong Thanh pho 116 Chi Minh).

3. Cong ty Co phan Duoc pham Tll’HARCO, dja chi: L6 08 - 09 Cum

Cong Nghicp va Tien thii Cong Nghiep Tan My Chanh, Phuong 9, thanh

pho My Tho, tinh Tien Giang.

(1) . Ho so hanh chlnh, phap ly ciia eo so:

Gia\ elurng nhan eo so du dieu kien an loan tlure pham so: 46/2019/ATTP-CNOMP ngay 17/7/2019 do Cue An loan thire pham eap Dal yen eau Tlure hanh san xuat tot (GMP) thire pham bao ve sire khoe.

(2) . Cong bo san pham:

Tai thoi diem thanh tra, Cong ty Co phan Dirge pham NPllARCO bao

eao: Cong ty eong bo 20 ho so1 con hien lire, trong do 1 2 san pham dang san xuat va kinh doanh. 08 san pham dura dira vao san xuat (Bao eao so

7

946/BC.71PHARCO ngay 20/11/2019 cua Cong ty Co phan Dupe pham

T1PHARCO kern theo).

(3) . Ghi nhan san pham: Doan thanh tra danh gia ve ghi nhan cua 06 san

pham tai kho Cong ty ghi nhan:

3.1 So san pham dirge kiem tra ve ghi nhan: 06 san pham

3.2 So san pham co nhan ghi dung quy dinh: 06 san pham

3.3 So san pham co nhan ghi khong dung quv dinh: 0 san pham

Cu the 06 san pham nhan phu hop voi cong ho la:

+ Thirc pham bao ve sue khoe Ira Gung kipha. 16 SX: 050519. NSX

02.05.19. BSD: 02.05.22: Npi dung ghi nhan phu hop voi nhan do Cong ty Co phan Dirge pham TIPHARCO eong ho dupe Cue An loan thire pham cap Ciiay

tiep nhan dang ky ban eong ho so 85 14 201 8/DKSP nga\ 24 10 20 I 8.

i I hue pham hao ve sue khoe I ra Chum Ngay. 16 SX: 021019. NSX22.10.19. USD: 22.10.21: Npi dung ghi nhan phu hop voi nhan do Cong tv C 6

phan Dupe pham I IPHARCO eong bo dirge Cue An loan thue pham cap Giay

tiep nhan dang ky ban eong b6 so 8512/2018/DKSP nga\ 24/10/2018.

+ Thue pham bao ve sue khoe Vien ngam Kueagitan. 16 SX: 010718. NSX

31.07.18, USD: 31.07.20: Npi dung ghi nhan phu hop voi nhan do Cong l\ Co

phan Dupe pham TIPHARCO eong bo dupe Cue An loan thue pham cap Gia) xac nhan eong bo phu hop quy dinh an loan thue pham so 47908/201 7/A 1 I P- XNCB ngay 19/12/2017.

+ Thue pham bao ve sue khoe Duong nao Tipha. 16 SX: 010818. NSX

27.08.18. HSD: 27.08.21: Npi dung ghi nhan phu hop voi nhan do Cong tv Co

phan Dirge pham TIPHARCO eong bo dirge Cue An Loan thue pham cap Gia) xac nhan eong bo phu hop quy dinh an loan thue pham so 8765/2017 A I TP- XNCB ngay 26/3/2017.

i Thue pham bao ve sue khoe Tra Thanh Nhiet kipha. 16 SX: 010319. NSX 03.03.19. HSD: 03.03.21: Npi dung ghi nhan phu hop voi nhan do Cong t) Co phan Dupe pham TIPHARCO eong bo dupe Cue An loan thue pham cap

Giay tiep nhan dang ky ban eong bo so 8513/201 8/DKSP ngay 24/10/201 8.

i Thue pham bao ve sue khoe Sim Ho kuca. 16 SX: 041010. NSX23.10.19, HSD: 23.10.21: Npi dung ghi nhan phu hop voi nhan do Cong i\ CO

phan Dupe pham TIPHARCO eong bo dirge Cue An loan thue pham cap Gia\ xac nhan eong bo phu hop quy dinh an loan thue pham so 35686/2016/ATTP-

XNCB ngay 21/12/2016.

(4) i)ieu kien bao dam an loan thue pham

Cong tv dirge Cue An loan thire pham eap Ciiay ehirng nhan eo1 so' du dieu

kien an loan thire pham dal yen eau Thire hanh san xual tot (GMP) thire pham

bao ve sire khoe so: 46/2019/ATTP-CNGMP ngay 17/7/2019 eae dang san pham sau: Vien nen. vien nen bao phim. vien nen bao dirbng. vien nang eirng. ebm. bot. vien nang siii. com sui. bot siii. siro. dung dich. tra boa tan. tra tui loe.

Tai thdi diem thanh tra ghi nhan Cong ly duy tri dieu kien an loan thire

pham dal yen eau Thire hanh san xual tot (GMP) thire pham bao ve sire khoe theo quy dinh; kho bao quan dap irng dieu kien bao quan thire pham: eo khu \ ire

liru man va thire hien liru man theo quy dinh: danh gia eae dieu kien bao dam an

loan thire pham khac phu hop theo tir danh gia va bao cao eiia Cong t\ Co phan Dirge pham 11PHARCO tai Bao cao so 946 BC. 1IP1 IARC() nga\ 20 1 1 2019.

(5). Quang cao san pham:

Theo bao eao eua Cong ty Co phan Dirge pham 11P11ARCO. Cong tv eo

website: tipharco.com.vn, Cong ty dirge Cue An loan thire pham cap 02 Gia\ xae nhan ngi dung quang eao eon hieu lire.

Tai thdi diem thanh tra. Doan thanh tra ghi nhan:

- Cong ty quang eao dang to roi. noi dung 02 to roi quang eao 02 thire

pham bao ve sue khoe phu hop vdi noi dung da dirge Cue An loan thire pham

xae nhan gom:

i [hire pham bao ve sue khoe Siro 1 lo Euea (Giay xae nhan eong bo phu

hgp quy dinh an loan thire pham so 35686/2016/AT I'P-XNCB) phu hgp vdi Giay xae nhan ngi dung quang eao so 00504/2017/AT IP-XNOC ngav

04/4/2017.

i Phire pham bao ve sue khoe Gbi earn cum hoa cue (Gia) xae nhan cbng

bo phu hop quy dinh an loan thire pham so 1065/2017/A 1 1 P-XNCB) phu hop

vdi Giay xae nhan noi dung quang eao so 00983/2017/A 1 1 P-XNGC ngav

19/6/2017.

- Website: tipharco.com.vn khdng quang eao eae san pham thire pham bao

ve sue khoe eua Cong ty.

(6). Lay man kiem nghiem: Doan thanh tra lay 03 man san pham thire

pham bao ve sue khoe. Ket qua kiem nghiem 03/03 man dat you eau (phieu

kidm nghiem sd 028099; 028100: 028109/PNK-Y TCC ngav 18/12/2019 eua

Vien Y te eong eong Thanh phd 116 Chi Minh).

4. Cong ty Co phan Thien Nhien Viet, dia chi tru so ehinh: So 1 15

Qnoc lo 50, Ap Phong Tinian, Xa I an My Chanh, thanh phd My I ho, tinh l ien (Gang

(I). 116 so hanh ehinh, phap ly ciia co so:

9

Giay chirng nhan ca sa du dieu kien an loan tlurc pham so: 001620/20! 7/ATTP-CNDK nga\ 21/12/2017 do Cue An loan dure phum cap

eho Chi nhanh Cong ty co phan Thien Nhien Viol, dia chi: Ap Long 116a. Xa Dao Thanh. Thanh pho My Tho. l ien Chang.

(2). Cong bo san pham:

Tai thai diem thanh tra. Cong ty co phan Thien Nhien Viet hao cao: Cong

tv cong bo 13 ho so con hieu lire, eu the:

- Thirc pham hao ve sire khoe VILN NGAM GU’NG VI1TNAT '' khong

du'ong do Cong ty co phan Thien Nhien Viet cong bo dirge Cue An loan thirc

pham cap Giay tiep nhan dang ky ban cong bo so 8247/2018 1 )KSP nga\ 16/10/2018.

- Thirc pham bao ve sire khoe Vien ngam COXII L.X 1 KA (iG'NCi Coxil Extra Ginger Lozenge do Cong t\ co phan Thien Nhien Viet eong bo duue Cik

An loan thirc pham cap Giay tiep nhan dang ky ban cong bo so

8402/2018/DKSP ngay 22/10/2018.

- Thuc pham bao ve sire khoe Vien ngam COXIL EXTRA Coxil Extra

Cough Lozenge do Cong ty co phan Thien Nhien Viet cong bo dirge Cue An loan thirc pham cap Giay tiep nhan dang k\ ban eong bo so 9771 CO 1 8 DKSP

ngay 04/12/2018.

- Thirc pham bao ve sire khoe Vien ngam COXIL EX TRA khong dirong

Coxil Extra Cough Lozenge Sugar Free do Cong t\ co phan Thie-n Nhien

Viet cong bo dirge Cue An loan thirc pham cap Giay tiep nhan dang k\ ban eong

b6 so 9772/2018/DK.SP ngay 04/12/2018.

- Thirc pham bao ve sire khoe Vien ngam VIACOl K do Cong tx co phan

Thien Nhien Viet cong bo dirge Cue An loan thirc pham cap Gia\ tiep nhan

dang ky ban cong b6 s6 10268/2018/DKSP nga> 1 7/12/201 8.

- Thirc pham bao ve sue khoe Siro COXIL (S1RO COXIL Coxil Natural Cough Relief Syrup) do Cong ty co phan Thien Nhien Viet eong bo dirge Cue

An loan thirc pham cap Giay tiep nhan dang ky ban eong bo so

10269/2018/DK.SP ngay 17/12/2018.

- Thirc pham bao ve sue khoe Vien ngam Viasol One do Cong t\ eo phan

Thien Nhien Viet cong bo dirge Cue An loan thirc pham cap Giay tiep nhan

dang ky ban cong bo so 10553/201 8/DKSP nga\ 26/12 20 I 8.

- Thirc pham bao ve sue khoe VIEN NGAM Viasol HUNG C11ANTI do

Cong ty co phdn Thien Nhien Viet cong bo dirge Cue An loan thirc pham cap

Giay tiep nhan dang ky ban cong bo so 5179/2019/DKSP ngay 1 5 05 201 9.

10

- Tlurc pham bao ve sire khoe VietNat" KEO GU'NG GINGER do Cong

ly co phan Thien Nhien Viel cong bo dirge Cue An loan tlurc pham cap Gia\ tiep nhan dang ky ban eong bo so 5178/2019/DK.SP ngay 1 5/05/2019.

- Thirc pham bao ve sire khoe Viaiux i' extra do Cong ly eb phan Ihien

Nhien Viel eong bo dirge Cue An loan thire pham cap Gia\ liep nhan dang k\ ban eong bb s6 6959/2019/DKSP ngay 12/06/2019.

- Thirc pham bao ve sire khoe VialuxT exlra khong duong do Cong l\ eb phan Thien Nhien Viel eong bb dirge Cue An loan thirc pham cap Gia\ tiep

nhan dang ky ban eong bb so 6960/2019/DKSP ngay 12/6/2019.

- Thire pham bao ve sire khoe VII'N NGAM MIAO MOC Ihien Nhien

Viet do Cong ly eb phan Thien Nhien Viet eong bb dirge Cue An loan thire

pham cap Giay tiep nhan dang ky ban eong bb so 7895/2019 DkSP nga\ 25/6/2019.

- Thire pham bao ve sire khoe Viacol Plus do Cong t\ eb phan Thien

Nhien Viel eong bb dirge Cue An loan thire pham cap Giay xac nhan eong bb

phu hop quy djnh an loan thire pham so 3953/2017'ATTP-XNCB nga\ 03/02/2017.

Tai thbi diem thanh Ira. theo bao eao eua Cong ly. Cong ly dang lam

ngirng san xuat eae san pham neu Iren, ehb xa\ dung nha ma> dal GMP mbi san

xuat tiep. l ong so san pham eo so da san xuat: 08 (Viaeok Viatux Exlra khong

duong. Viatux Extra, Girng Vietnat khong duong. Siro 1 ae Viatux. Viasol hung

chanh, Viacol plus. Gung Vietnat. Viasol que). Cae mat hang nay eong tv da san

xuat triroc ngay 01/07/2019 va da xuat ban bet. hien tai khong eon ton kho.

(3) . Chi nhan san pham: Doan thanh tra khong danh gia

(4) . Dieu kien bao dam an toan thirc pham

Doan thanh tra ghi nhan theo bao eao eua Cong ly: Triroc nga_\ 01/07/2019, Cong ly san xuat thire pham bao ve sire khoe tai Chi nhanh Cong t>

Cb phan Thien Nhien Viet, dia chi: Qubc lb 50. ap I ong Mba. xa Dao I hanh. TP. My Tho, tinh Tien Giang theo Giay ehirng nhan eb so du dieu kien an loan

thire pham so 001620/2017/ATTP-CNDK ngay 21/12/2017 do Cue An Loan

thirc pham cap. Tir ngay 01/07/2019 den nay. Cong ty da ngirng san xuat thire

pham bao ve sue khoe do eo so tai Chi nhanh Cong t\ Cb phan I hien Nhien

Viet do khong dap irng dieu kien ve GMP dbi vbi thire pham bao \e sue khoe. Cong tv dang xay dung nha may san xuat thire pham bao ve sue khoe theo lieu

- I huc pham bao ve sue khoe V1I-N BAO DUONG NGOC LI UN

PHONG NHUAN GAN SO 40 do Co so san xual Dong Nam Dupe Ngpe Lien

edng bo dope Cue An loan thpe pham cap Giay tiep nhan dang ky ban edng bo

IILU

ehuan GMP tai L6 A IV-3 va A IV-4. KCN Giao Long, xa An Phubc. huyen

Chau Thanh, tinh Ben Tre.

Tai thbi diem thanh tra ghi nhan tai Chi nhanh Cong t_\ Co phan I hie'n

Nhien Viet (dia chi: Ap Long Hoa. Xa Dao Ihanh. I hanh phb My I ht). lien

Giang) khong san xual thpe pham bao ve sue khoe: tai kho Chi nhanh C ong l\ khong eo san pham thpe pham bao ve sue khoe.

(5) . Quiing cao san pham:

Theo bao cao cua Cong ty Co phan I hien Nhien Viet. Cong ly eo

website: vietnat.vn. Cong ty hien tai dura thpe hien quang eao eae san pham

thpe pham bao ve sue khoe eua Cong ty tren website nay.

Tai thbi diem thanh tra. Doan thanh tra ghi nhan website: vietnat.vn

khong quang eao eae san pham thpe pham bao \e sue khoe eua Cong t\.

(6) . Lay man kiem nghiem: Doan thanh tra khong la\ man

5. Co so' san xuat Dong Nam Dupe Ngpe Lien, clja elu: 127/9 Le I hi I Icing Gam, PhircVng 6, thanh Pho My Tho, tinh Tien (bang

(1) lib so hanh ehinh, phap ly eua eo so:

Giay ehung nhan eo so du dieu kien an loan thpe pham so: 28/2018/ATTP-CNDK ngay 17/7/2018 do Chi cue An loan ve sinh thpe pham

tinh Tien Giang cap eho Co so san xuat Dong Nam Dirge Nggc Lien.

(2) . Cong bb san pham:

l ai thbi diCan thanh tra. Co so san xual Dong Nam Dupe Ngpe Lien bao

eao: Co so cbng bb 09 hb so eon hieu lire, cu the:

- Thpe pham bao ve sire khoe bb phe giam ho so 5 do Co so san xual Dong Nam Dupe Ngpe Lien cbng bb dirge Cue An loan thpe pham cap Gih\ tiep nhan dang ky ban cbng bo so 10089/2018/DKSP nga> 12'12/2018.

- Thpe pham bao ve sire khoe TILU PIIONCi NIIUAN GAN SO 40 do

Co so san xuat Dong Nam Dupe Nggc Lien cbng bb dupe Cue An loan thpe

pham cap Giay tiep nhan dang ky ban cbng bb so 9536/201H/DKSL ngav

28/11/2018.

- Thpe pham bao ve sue khoe Da da) do Co- so san xuat Dong Nam Dupe

Ngpe Lien cbng bb dupe Cue An loan thpe pham cap Gia\ tiep nhan dang ky

ban cbng bo sb 10088/2018/DKSP ngay 12/12/2018.

- Thpe pham bao ve sue khoe NGOC L1LN SOI T1 IAN I lO.AN do Co sb

san xuat Dong Nam Dupe Ngpe Lien cbng bb dupe Cue An loan thpe pham cap

Giay tiep nhan dang ky ban cbng bb sb 9535 2018 DK.SP ngay 28/1 1 201 8.

- Thirc pham bao ve sue khoe NGOC MEN SOI THAN HOAN. 16 SX: 010619, NSX 010619, HSD: 30 thang ke tir nga\ san \ual: Noi dung ghi nhan

phu hap vai nhan do Co so san xuat Dong Nam Dirge Ngge I ien cong bo dirge

Cue An loan thirc pham cap Giay tiep nhan dang ky ban eong bo so

9535/2018/DKSP ngay 28/11/2018.

- Thirc pham bao ve sire khoe Da day, 16 SX: 010818, NSX 050818. USD: 050821: Noi dung ghi nhan phu hgp vai nhan do Ca sa san \uat Dong

Nam Dirge Ngge Lien eong bo dirge Cue An loan ilurc pham cap Gia\ liep nhan dang ky ban eong bo so 10088/2018/DKSP nga\ 12/12/ 201 8.

- Thirc pham bao ve sue khoe TIED PHONG NHUAN GAN SO 40. 16 SX: 010119, NSX 030119, HSD: 030721: Noi dung ghi nhan phu hgp vai nhan

do Ca so' san xuat Dong Nam Dirge Ngge Lien eong bo dirge Cue An loan dure pham cap Giay tiep nhan dang ky ban eong bo so 9536/2018/DKSP nga\ 28/1 1/2018.

- Thirc pham bao ve sire khoe Giai earn giam nhire moi, 16 SX: 010818. NSX 090818. HSD: 090821: Noi dung ghi nhan phu hgp vai nhan do Ca so' san

xuat Dong Nam Dirge Ngge Lien eong bo dirge Cue An loan thirc pham cap

Giay tiep nhan dang ky ban eong bo so 10087/2018/DKSP nga\ 12/12/2018.

- Thirc pham bao ve sue khoe bo phe giam ho so 5. 16 SX: 010519. NSX

160519, HSD: 160522: Noi dung ghi nhan phu hgp vai nhan do Ca sa san xuat Dong Nam Dirge Ngge Lien eong bo dirge Cue An loan ilurc pham cap Gia\ liep nhan dang ky ban eong bo so 10089/2018/DKSP ngay 1 2/12/201 8

- Thue pham bao ve sue khoe T1EIJ PHONG NHUAN GAN SO 40. 16

SX: 010519, NSX 310519. HSD: 36 thang ke tir nga\ san xuat: Noi dung ghi nhan phii hgp vai nhan do do Ca sa san xuat Dong Nam Dirge Ngge I ien eong

bo dirge Cue An loan thirc pham cap Giay tiep nhan dang ky ban eong bo so

9536/2018/DKSP ngay 28/11/2018

(4). Dieu kien bao dam an toan thirc pham

Doan thanh tra ghi nhan theo bao eao eiia Ca sa san xuat Dong Nam Dirge

Ngge Lien: Truae ngay 01/07/2019. Ca sa san xuat Dong Nam Dirge Ngge Lien

san xuat tai ca so' theo Giay chung nhan ca sa du dieu kien an toan thue pham

so: 28/2018/ATTP-CNDK ngay 17 7 2018 do Chi cue An loan \e sinh thue

pham linh Tien Giang cap. Tir ngay 01/07/2019 den na>. Ca sa san xuat Dong

Nam Dirge Ngge Lien da ngirng san xuat thue pham bao ve sire khoe tai Ca sa

san xuat Dong Nam Dirge Ngge Lien do khong dap irng dieu kien \e GMP doi vai thire pham bao ve sire khoe.

Tai thai diem thanh tra ghi nhan tai Ca sa san xuat Dong Nam Dirge Ngge

Lien, dia chi: 127/9 Le Thj Hong Gam. Phirang 6. thanh Pho My Tho. linh I ien

14

Giang khong san xuat thuc pham bao ve sue khoc: tai kho Co- so- san xuai Dong

Nam Dirge Ngge Lien liru man 08 san xuat thuc pham bao ve sue khoe.

(5) . Quang cao san pham:

Theo bao eao ci’ia Co so' san xuat Dong Nam Dirge Ngge Lien, ('o' so

khong co website, Co so khong thuc hien quang eao cac san pham tlure pham

bao ve sire khoe.

(6) . Lay man kiem nghiem: Doan thanh tra khong lay man

III. KET LUAN

1. Cong ty TNI 111 Mot lhanh vien I lien Ilai Phat. dja chi: So 69CL duong

so 1, khu Pho My Tan, plurong 7, thanh pho Ben Tre, tinh Ben Tre

(1) . Cac noi dung eo so thire hien dung: Cong ty da co Giay ehirng nhan

dang k\ doanh nghiep; eae san pham Cong t\ kinh doanh tai thdi diem lhanh tra

eo ho so eong bo eon hien lire.

(2) . Cac hanh vi vi pham, ton tai:

Cong ty TNI III Mot thanh vien Hien Hai Phat vi pham qu\ dinh ve noi dung bat huge tren nhan hang hoa doi voi 02 Id san pham tlure pham bao ve sue

khoe sau:

i Thuc pham bao ve sue khoe HEMO VEIN

010618, NSX 16/6/18, USD: 15/06/21: Noi dung ghi nhan khong phu hgp vdi nhan do Cons tv TNI 111 Mol thanh vien Mien Ilai Phat cbng bo diroe Cue An loan tlure pham cap Giay tiep nhan dang ky ban edng bd so 2746/201 8/DkSP

ngay 21/5/2018. eu the: Nhan ghi them noi dung ve edng dung, thanh phan Cao

diep ca theo noi dung tren nhan la 250mg (noi dung hd so' edng bd la 200mg).

i Thuc pham bao ve sue khoe Calmax Pluss Nhat l am. Id SX: 180633. NSX 16/08/18, USD: 15/08/21: Noi dung ghi nhan khong phu hgp vd'i nhan do Cong tv TNHH Mot thanh vien Hien Hai Phat edng bd dirge Cue An loan thire

pham cap Giay tiep nhan dang ky ban edng bd so 4290/2018/DKSP ngav

12/7/2018. eu the: Nhan ghi them noi dung ve edng dung, ddi tirgng sir dung

2. Cong ty co phan Sa Sam Viet, dja chi: So 430C1 Nguyen Hue, Phudng Phu Klurong, thanh pho Ben Tre, tinh Ben I re

(1) . Cac noi dung eo so thire hien dung:

- Cong ty da co Giay cluing nhan dang ky doanh nghiep.

- Kiem tra hd so 08 san pham thire pham bao ve sire khoe cua Cong tv ghi nhan hd so edng bd cac san pham eon hien lire: ndi dung ghi nhan phu hop vdi nhan trong hd so' edng bd dirge Cue An loan thire pham xac nhan.

(2) . Cac hanh vi vi pham. ton tai: Khong ed

II NHAT rAM. Id SX:

15

san pham thirc pham bao ve sire khoe vi pham 1)11) dinh ve nbi dung bat bude

tren nhan hang boa. bao dam nhan san pham lim hanh dung \ di cong bd.

2. Doi vdi cac co sd tren dia ban tinh Tien (iiang. C ue An loan tlure pham

giao Chi cue An loan ve sinh thire pham tinh T ien (iiang giam sat boat dong san

xuat, kinh doanh thue pham bao ve sire khoe doi vdi cac co' sd tren dia ban. Giam sat boat dong cua Co' sd san xuat Dong Nam Dupe Ngpc Lien va C dug l\ Cd phan Thien Nhien Viet, 02 co' sd nay dang lam ngirng san xuat thue

pham bao ve sue khoe tu ngay 01/7/2019 den thdi diem thanh Ira do khdng dat yen can thue hanh san xuat tot (GMP). bao dam co so thue hien dung quy dinh

ve dieu kien an loan thue pham doi vdi eo sd san xuat thire pham bao ve sue khoe quy dinh tai Nghj dinh sd 15/2018/ND-CP \ a T hong lir so 18 2019 T T - BYT ngay 17/7/2019 cua Bo tnrdng Bp Y te.'.qj^^

T IU/ONC.VV^Noi nluin:- Bo tnrong (de bao cao):- Thir H uong Truong Quoc Cuong (de bao cao);- riianh Ira Bo Y te (de biet);- PC T. Do Huu Tuan (de biet);- Thanh tra So' Y te Ben Tre, Tien Giang (de biet);- Chi Cue ATVSTP Ben Tre. Tien Giang (de thue hien):- Cong ly TNHH Mot thanh vien Hien Hai Phat. Cong t\ co phan Sa Sam Viet. Cong ly Co phan Dupe pham TIPHARCO, Cong ty Co phan Thien Nhien Viet. Co so san xuat Dong Nam Dirge Ngpc Lien (de thue hien);- Website Cue AT I P (de cong khai):- Liru: VT. PCTTR.

psiCcue

Icf ANTOA \THl/C PH/

C-:-Ao

Nguyen Thanh Phong

18