19
m'du s6 19 CONG HOA XA HO1 CHI) NGH1A V1LT NAM Dec lap - Tkr do - Hanh phric DON DE NGHI Cap GiAy chirng nhan dü dieu kien kinh doanh dugc Kinh (1) SO Y te Tp.HCM Ten ca sO Nha Thuoc Dia chi: Hujrnh Van] t, phuong , quan PIM Nhuan Tivc thuec (lieu la co sa true thuec) : khring Dia chi . Nguai chiu trach nhiem chuyen mon ve dugc: TrAn Thi SO CCHN Dugc: 1042/HCM-CCHND Ncri cap: SO . Y Te TP H6 Chi Minh Nam cap: 2013. CO gia tri den (n8u co): khong thai han Nguai phu trach ve bao darn chAt luvng(2) SO CC - IN Dugc Nai cap Nam cap 1. Da dugc cAp GiAy chnng nhan thuc hanh tot(3): o - GiAy chi:mg nhan time hanh tOt SO: Ngay cAp: - GiAy chUng nhan thuc hanh tot SO: Ngdy cap: 2. Da dugc cap GiAy chUng nhan dO dieu kien kinh doanh dugc (4): o - GiAy chi:mg nhan dO dieu kien kinh doanh dugc so. NO)/ cap: - GiAy chnng nhan dO dieu kien kinh doanh dunce s6. Ngay cap: Co ser de nghi BO Y te/Se'r Y te cAp GiAy chüng nhan dO dieu kien kinh doanh dugc: n 9 re) /— / Loai hinh co sex kinh doanh (5): Li1) 36 bort -titithe - *Joe --- + Ph4m vi kinh doanh (6): ban le thuoc -floc( trni-u 5 alltEt tifiii eirtAIV , A. + Dia diem kinh doanh: 247 Huynh Van Banh, phuang 12, quan PhO Nhuan Chung tOi xin cam ket tuan thil day dil ,cac quy dinh cOa phap luat cO lien quan, chap bath nghiorn su chi dao cna BO Y te/Ser Y te. Ca sra xin gni ken) theo don nay cac tai lieu d nghi cAp lai giAy CNDDKICDD quy dinh tai Dieu 32 oh Nghi dinh sO: 54/2017/ND-CP ngay 08/05/2017 cOa Chinh phil quy dinh chi tiet me so dieu va bin phap thi hanh Lust dugc. Pft

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Page 1: m'du s6 19 CONG HOA XA HO1 CHI) NGH1A V1LT NAM DON DE …file.medinet.gov.vn/Data/soytehcm/\soytehcm\Attachments/2017_9/DDK DUOC... · (2) Chi áp dung doi vai co sO san xuAt thuoc,

m'du s6 19

CONG HOA XA HO1 CHI) NGH1A V1LT NAM Dec lap - Tkr do - Hanh phric

DON DE NGHI

Cap GiAy chirng nhan dü dieu kien kinh doanh dugc

Kinh (1) SO Y te Tp.HCM

Ten ca sO Nha Thuoc

Dia chi: Hujrnh Van] t, phuong , quan PIM Nhuan

Tivc thuec (lieu la co sa true thuec) : khring

Dia chi .

Nguai chiu trach nhiem chuyen mon ve dugc: TrAn Thi

SO CCHN Dugc: 1042/HCM-CCHND Ncri cap: SO. Y Te TP H6 Chi Minh Nam cap: 2013. CO gia tri den (n8u co): khong thai han

Nguai phu trach ve bao darn chAt luvng(2)

SO CC -IN Dugc Nai cap Nam cap

1. Da dugc cAp GiAy chnng nhan thuc hanh tot(3): o

- GiAy chi:mg nhan time hanh tOt SO: Ngay cAp:

- GiAy chUng nhan thuc hanh tot SO: Ngdy cap:

2. Da dugc cap GiAy chUng nhan dO dieu kien kinh doanh dugc (4): o

- GiAy chi:mg nhan dO dieu kien kinh doanh dugc

so. NO)/ cap:

- GiAy chnng nhan dO dieu kien kinh doanh dunce

s6. Ngay cap:

Co ser de nghi BO Y te/Se'r Y te cAp GiAy chüng nhan dO dieu kien kinh doanh dugc: n 9 re) /— /

Loai hinh co sex kinh doanh (5): Li1) 36 bort -titithe - *Joe ---

+ Ph4m vi kinh doanh (6): ban le thuoc -floc( trni-u5 alltEt tifiii eirtAIV,A.

+ Dia diem kinh doanh: 247 Huynh Van Banh, phuang 12, quan PhO Nhuan

Chung tOi xin cam ket tuan thil day dil,cac quy dinh cOa phap luat cO lien quan, chap bath nghiorn su chi dao cna BO Y te/Ser Y te.

Ca sra xin gni ken) theo don nay cac tai lieu d nghi cAp lai giAy CNDDKICDD quy dinh tai Dieu 32 oh Nghi dinh sO: 54/2017/ND-CP ngay 08/05/2017 cOa Chinh phil quy dinh chi tiet me so dieu va bin phap thi hanh Lust dugc.

Pft

Page 2: m'du s6 19 CONG HOA XA HO1 CHI) NGH1A V1LT NAM DON DE …file.medinet.gov.vn/Data/soytehcm/\soytehcm\Attachments/2017_9/DDK DUOC... · (2) Chi áp dung doi vai co sO san xuAt thuoc,

Tp.HCM. ngay 11 thang 07 nam 2017 Nmiti clai diem trutc phap Mat/ Nguti

duty üy quyen (Ky, ghi it hp ten, chile danh, &mg d'au

(lieu co))

DS.T11.$71. C

Ghi

(1) Ca quan cAp GiAy chimg nhan dfi (lieu kin kinh doanh dugc.

(2) Chi áp dung doi vai co sO san xuAt thuoc, nguyen lieu lam thuec va khi bat buOc phai có CCHND dEi vol nguti phu trach dam bao chat lugng theo 10 trinh guy dinh trong Nghi dinh.

(3) Lit ke GiAy chung nhan GPs con hieu lye tAi dia diem kinh doanh nEu cO.

(4) Lit ke GiAy chirng nhan dci dieu kin kinh doanh dugc cOn hieu lyc neu co.

(5) Ghi rO loai hinh ca sey kinh doanh theo guy dinh tai khoan 2 Dieu 32 cila Lust Mite.

(6) Lit ke cac pham vi kinh doanh Mang Ung vOl dieu kin kinh doanh Mite ma ca so. de nghi va dap Ung, la m'Pt hoac met sE pham vi theo guy dinh tai cac Dieu 15 den 22, Dieu 33 va 34 cUa Luat clutc.

Page 3: m'du s6 19 CONG HOA XA HO1 CHI) NGH1A V1LT NAM DON DE …file.medinet.gov.vn/Data/soytehcm/\soytehcm\Attachments/2017_9/DDK DUOC... · (2) Chi áp dung doi vai co sO san xuAt thuoc,

• • * • • • • • • •

Nana sinla: 19'

Trinh it6 chuyen mem:

Dia chi thueng

DO nen chuan hanh ligh

, Phirtmg Van, TP HCM ..

•• kinh doanh .

•+ it

Mu& sau:* --- et A .

San xuat, xufit Ulan, nhap khau, ban buon, ban la, • **

dich vu bao quint vailltIFiit kiem nghiein thutic •4 ,

+4 TP. H6 Chi Minh, ngay_20thang20 nam 2013 •* •

ti4 GIAM DOC ,H....„ .

At,

Gi ikA4 DOC * +

ni. si

lgY

4.1e1/4°S

, op

iey

• •4 4+ • PGS. TS. PHANI ICH_ANH PHONG LAN •

*Ghi ddy dii cac logi hinh lunh cloonh thuaic ma cal nhan dzi clta'u kien, nhzrng +11. khi hanh ngha chi chr9c la ngwed quan ly chuyan mon nig mOt loai hinh et

• • * • • * • • • • • * * * 4 • • • * • * • 4 • 4 4 • t • • 4 4 • + * • • 4 • • •

SO 024953339

+ 49 + • • • •

* * • • • • • • • • • • • • * * • • • 4, • • • • • • ••••• * • • • • • • • * • • • • • • • • • • • • • • • • • • • * • • *

CONG HOA HOI CHU NGHIA. VII;T NAM • DOc lp - Tu. do - Hatih pink • • • • 49 GIAM D6C So Y Ttv •

+4I

(TY BAN NHAN DAN TH,kNH PHO HO CHI MINH

SOYTE

4

66: /11CM-CCEND ChUng chi nay thay th cho CCHN s6. 0481/CCHND do Su Y th TP.HCM cap ng ay 05 thong 12 narn 2007 Chnng nhOn Ong (Pa):

TRAN THI C

Chirng chi c6 gia tri tü ngay /0 thang2.0 nam 2013

• * • • • • +

Page 4: m'du s6 19 CONG HOA XA HO1 CHI) NGH1A V1LT NAM DON DE …file.medinet.gov.vn/Data/soytehcm/\soytehcm\Attachments/2017_9/DDK DUOC... · (2) Chi áp dung doi vai co sO san xuAt thuoc,

UY BAN NHAN DAN CONG HOA XA HQI CHU NGHIA V1tT NAM QUAN PHU NHUAN DO 14p — Ty- do — Ilanh phoc-

,

ItJ 840.1

GIAY CHUNG NH:4N BANG Kt HO 1ONH DOANH

SO: 41P8012941 Bang kji lcin (Mu, ngay 24 dicing 08 nam 2010

Dang (hay ddi lcin 2, ngay 01 thang 6 Wm 2017

1. Ten hi) kinh doanh: NHA THUOC

2. Dia diem kinh doanh: ' Huynh Van B , Phtrang , Quan Phit Nhu:an Dien thogi: Fax:

3. Nganh, nghe kinh doanh: Ban le thuoc, dung C1.1 y te, thtic pham chirc nang, pham, san pham cham soc the Ichoe.

4. VOn kinh doanh: 1.000.000 dang (1 trial (long)

5. H9 irk ten di din hO kinh doanh: Gifri tinh: Sinh ngay: VC /19i Chung minh nhan dan sa: Ngay cAp:

TRAN TH1 C—

Nai cap: Citing an Tp.HCM

Dan tOc: Kinh QuOc tich: Viet Nam

Nai clang kY h.° khan thmang tra: Le Van phttang quan Go Vap, Tp.HCM

Chii tai: , phtrerng 1 (pan Binh Thanh, Tp.HCM

Chang that barysp? gang vetban chiK1T. CHU TICH flk

S'OchIng tho Quyen se U TICH

WRONG PHONG TUPHAP Q, P

Ngay .0.6. 78.6- 2/111

111%;

PHONG

&Si 49e Flido

Page 5: m'du s6 19 CONG HOA XA HO1 CHI) NGH1A V1LT NAM DON DE …file.medinet.gov.vn/Data/soytehcm/\soytehcm\Attachments/2017_9/DDK DUOC... · (2) Chi áp dung doi vai co sO san xuAt thuoc,

Mau s6 6/KKNS‘ Ban Ice khai danh sach nhan su va hang can chuven mon

NHA. THUOC CONG HOA XA HOI CHU NGHIA VIET NAM THIEN P11156C Doc lap - Tu. do - Hanh Wide

BAN KE KHAI DANN SACH NHAN SV VA BANG CAP CHUYEN MON

Ca s6 kinh doanh: Nha Thu6c A_ H9 ten chili co sa: Dian Thi I C. S6 CCHND: VHCM-CCHND

Dia diem kinh doanh: HuSith Van 1, phuang I quan Pho Nhuan

DT: Pham vi kinh doanh: Ban le thuoc thuoc thanh pham.

STT 119 va ten

Nam sinh Dia chi

thirirng fru

Trinh de

chuyen men

Na m Mt nghierp Noi cap

bang

Cana viec tr, . dove phan

cling

Nam Nit

01 Trail Thi 0..... 19 Le Van

, phoong 9,

quan GO \Tap,

Tp.HCM

Dopy Si

Di HOC Dal HQC Y Dugc

Tp.HCM

Duoc Si Phu trach

Chuyen Mon, Chu

Nha Thuoc

02 Nguye'n Thi T: . ; 19r - nguyen

Him Canh,

phtreyng .

Qi 1 Binh

Ti , Tp

HCM

Dugc Si

Trull° a H9c

Trurynoa. TC

KT va CN Um

Long, Tp HCM

Nhan vien ban

thutic

03 Nhan vien ban

thuric

TP.HCM / ngthy 11 thang 07 neim 2017 Chn co se( cam doan khai dung sir that

Kj ghi ro hp ten

DS. Tran Thi

Page 6: m'du s6 19 CONG HOA XA HO1 CHI) NGH1A V1LT NAM DON DE …file.medinet.gov.vn/Data/soytehcm/\soytehcm\Attachments/2017_9/DDK DUOC... · (2) Chi áp dung doi vai co sO san xuAt thuoc,

MAu sa 7/KKDD-TTB Bang IcE khai dia diem va trang thiet bi dia co' ser kinh doanh thu6c

CONG HOA XA H91 CHIO NGHIA VIET NAM Dec lap - Ttr do - Hanh phtic

BAN KE KHAI DIA DIEM VA TWANG THIET BI CIA CO SO KINH DOANH THUOC

Ca sac kinh doanh: Nha Thu6c

Nguai phi) trach: TrAn TN C,

Dia diem:. '1±1unh Van phtrang , °plan PhU Nhuan Dien tich : 15 m2.

Ca sa rieng biet hay chung voi ca sâ khac: ca ser rieng biet

MO tã scr 130 clieu kien ca s&: (nn, Iran nha, v sinh mOi truang) nen nha lat gach, tran nha bang be

tong chac than, cfra kinh, ca sä vat chat hi'en dai, sach s'e darn bao ye sinh mOi truang.

Trang thiet bi (TU, quay, danh sach may mac, thiet bi, dieu kien PCCC....): Ta: 3cai, Quay:2 cai,

May lanh: 1 cai, Binh chita chay: 1 binh, May vi tinh: 1 b0, May in: I cai, Nhiet Am ke ca hieu chuAn:

1 cai.

Tai lieu chuyen men, van ban phap luat, quy the clugc, se sach theo dOi:

Quy trinh thao tac chuan, S6 theo dOi nhiet do- do Am hang ngay, S6 theo dOi tac dung phu cQa thu6c,

S6 theo dOi chat lugng thuot c dinh ki, Cac Milieu tham khao thu6c: MIMS, VIDAL,"I

.7_101026_1c ) Naht:-D?\11. 64-lobitcao divaS%Theng fix s6 46/2011/TT-BYT, Phan mem quail 1 Thu/6c, ' _ _ _ _ _ Thong Pr 05/2016/ TT-BYT. Su (16 dia diem kinh doanh (Tie 6 mat sau: r5 vi tri, so nhit, ten pha, phztong, ng5, x5m, cac nha thuac ga n nhat va cac ddc diem de nhan biet khcic...)

TP. HCM, ngay 11 Mang 07 &dm 2017 Giam dc doanh nghiep/ Chit cif so'

(10)gbi rd hp ten)

DS. Tran Thi .e,

Page 7: m'du s6 19 CONG HOA XA HO1 CHI) NGH1A V1LT NAM DON DE …file.medinet.gov.vn/Data/soytehcm/\soytehcm\Attachments/2017_9/DDK DUOC... · (2) Chi áp dung doi vai co sO san xuAt thuoc,

Mau sO 1/GPP

ONG HOA XA H91 CHO NOMA VIET NAM Ercic 14- Ty' do- H?nh pink

TP. Ha Chi Mink ngery 11 Mang 07 neim 2017

DON BANG KIEM TRA "THVC HANH TOT NHA THUOC"

Kinh So. Y tt Thanh ph6 HO Chi Minh

- Ca sa: MIA thuilc 741/4

- Tryc thuOc: khong (110 kinh doanh cá the)

- Dien thoai: - Dia chi: ' Huynh Van , guan Pha Nhuan Ngtrai phy trach chuyen mon: Tran Thi ,

Ching chi hanh nEhe se: 1/1-1CM-CCHND cap ngay /20 do SO Y to TP.HCM cap.

Ca ser thing toi a nghi So. Y te' Thanh ph O HO Chi Minh kiem tra d ding nhan ca ser chong tOi dat tieu chuan, nguyen the "Thyr hank tot nhã Mak".

ChUng t8i xin gui kern theo ban clang k cac tai lieu sau:

Ban chtip Giay chrng nhan dang ky kinh doanh;

Ban chinh Ching chi hanh ngheeña ngtrai quail 1 chuyen mon;

Ban ke khai ca kr vat chat, trang thiet bi chuyen mOrt;

Ban ke khai danh sach nhan sp.;

— Ban ty kiem tra GPP theo danh mve kiem tra guy dinh tai Phy lye II thong tu s6 46/2011/TT-BYT ngay 21/12/2011.

Divot si chii nha thuOc

Ds. Tra'n Thj .C.

Page 8: m'du s6 19 CONG HOA XA HO1 CHI) NGH1A V1LT NAM DON DE …file.medinet.gov.vn/Data/soytehcm/\soytehcm\Attachments/2017_9/DDK DUOC... · (2) Chi áp dung doi vai co sO san xuAt thuoc,

Huung din chung

I . M)1.1 C dich dvng danh mvc De co se kinh doanh thtrc hien GPP, ginp Co. s& ty kiem tra danh gia.

- De ca,quan quan duck kiem tra, danh gia, Ong nhfin GPP. De theng nhat tren toan quek viec dirk hien GPP.

2. Nguyen tic chAm dim - Tong so diem chuan lieu co sa co du cac hog dOng trong GPP (bao gem cA pha che theo don via

c6 kho bao quan thuac) la 100 diem Diem chuan duvc xay dyng trong khoang tit. 0,5 den 2 tny thuOc tiring tieu chi (nguyen tac trian

khai tUng buck). - Cric tieu chi can chu y:

Cho diem cang (dim khuyen khich) nu co se timc hien cao hon cac quy dinh tai thieu. Tang s6 10 diezni Ong.

Cho diem trir neu co se c6 thyt hien thy nhien con c6 nhiL: tan tai. Tang se 9 diem trir. - Cm diem khong chap thufin neu co so khong thyc hien met si tieu chi. Tang se 9 diam kheing

chap thufin. - Wing phfin in nghieng: kiem tra them bang hinh thirc pheng van.

3. Cach tinh ditm 3.1. Cho diem raj da, khong Cho diem trung gian 3.2. Nhirrig boat clang co se. kheing có, vi dy: Kheng pha che theo don, kheng c6 kho bAa quan trir diem chufin, Cy the:

Khan CO pha che theo don diem chtian: 95 Kheng co kho bao quan diem chuan: 98

- Kheing CO ca pha che theo don va kho diem chuan: 93 3.3. Wei vai co sr clang hog Clang viec kiem tra, chain diem citroc tinh trail hog clOng thtsc ta tui co se. 3.4. Doi vor co sof mei thanh lap, chua hoat clang:

- Nhung tieu chi eta duvc then khai trong qua trinh chuanbi: Tinh diem nen kat qua. thyt te. - Nhing fiat] chi chi kill hoat clang mdi dien ra: Duvc tinh diem neu tieu chi do da dugc quy dinh

trong S ha so tai lieu, cac van ban, cac quy trinh thao rac chuan, cac bleu trien khai boat clang via da duck nguei CO tharn quyen k duyet ban hanh, nhan vien co sa duck deo Lao, nam duet va thyt hanh dung.

4.Cach It6t lu4n - Co so. khang mac loi nao thuck diem kheng chap amain: - Tic 90% diem tre ten: Co so duck xet ding nhAn. Neu CO ten tai, de nghi khac phyc ton tai trong

thgc.hien GPP va lam can CU Cho nhing Ian thanh tra, kiem tra k tiap. - Tu. 80% den 89% diem: Co ser can khac phuc va c6 bao cao bang van ban trong yang 30 ngay de

doan kiem tra xem xet de nghi cap GCN. Neu sau 30 ngay co so chua kJ-fat phyc duce VA co ser 7, van muon hanh nghe thi can phai nap h6 so d& duvc kiem tra lai.

- Duel 80% diem: Co se can khac phtic cle kiem tra lal.

Co se mac met lei thuec diem khong chap thrian: Co sey can khac phyc d kiem tra lai.

1

Page 9: m'du s6 19 CONG HOA XA HO1 CHI) NGH1A V1LT NAM DON DE …file.medinet.gov.vn/Data/soytehcm/\soytehcm\Attachments/2017_9/DDK DUOC... · (2) Chi áp dung doi vai co sO san xuAt thuoc,

Danh trine kiem tra "Thkrc Jinni) tat nhei thu6c" (checklist)

STY Ni dung 1

Ten ca set: Nha thu6c -A. _ Dia chi: 1-1u9nh Van .II, , phutng , quan PhO Nhuan

SO dien thool: i - Fax: Email: , 2 TEn chu ca set/ nguti guar' 19 hoot Ong chuyen mon DS. Trfin Thi e....._

Giay chimg nhan &I clieu kin kinh doanh thuoc: 3 Looi hinh clang lq, kinh doanh:

- HO cà the: x . - Dia diem ban le caa doanh nghiep•

Dia diem ban he cita Co sa KCB

TT Ni dung Tham chieu

Diem chufin

Diem e(ing

Diem trir Diem dkit

Chi chn

1 2 3 4 5 6 7 1 \Ulan skr: 19 diem

1.1 Nauti clam K chuven mem

1.1.1 CO mat khi ca se( ban le hoat clOng hoc thtrc hien u9 quyen theo quy clinh

I11.4b 2 Diem khong chap fru*

2

1.1.2 CO trpc tip tham gia ban thu6c Ice don

1 I I I

111.46 2 2 Kim tra (1) SOP mutt DS CO kiern soat boat tieing nay khOng (2) kiem tra thpc IC

1.1.3 Co tham gia kiem soat chat 1- trong thu6c khi nhap ye va.trong quo trinh bao (Nan tai nha thuec

II1.4b 1 1 Kiel» tra SOP va phOng van ve vai ire dia DS trong viec kiem seat chat luvng

1.1.4 CO %buying xuyOn cap nhOt kiln thzir chuyon mon

111.4b 2 2 Phemg van DS.

2

Page 10: m'du s6 19 CONG HOA XA HO1 CHI) NGH1A V1LT NAM DON DE …file.medinet.gov.vn/Data/soytehcm/\soytehcm\Attachments/2017_9/DDK DUOC... · (2) Chi áp dung doi vai co sO san xuAt thuoc,

TT Nal dung Tham clii6u

Diem chuan

Diem cling

Diem tra Diem dal.

Ghi an

1.1.5 CO ciao tao hwang dcin nhOn vien qzty che, kiln thiltr chuye.n mon

111 4b 2 2 (phong vcin, nhcin wen, k Ira Ito sa ciao tgo niten vi en)

1.1.6 CO Intang dan nhon vier'? theo dot the the dyng kitting mong inuon Vil boo ccio yeti Co quan y U?

111.46 1 1

1.1.7 CO cang tot. yeti y le ca set 111.4b 0,5 0.5

1.2 bigirai ban le

1.2.1 CO dO nhan vien One \to , cho haat Ong cOa nha thuoc. So hx-ong nhan vien: Duce sy dal hoc- 1.... Dugc sy thing hoc. Dago la - Cac bAng cAp khac:

1.2 1 1

Co so có tn. 2 DSDH tra len 2

1.2.2 Bang cap chuyen men phu hop vai cong viec dace giao

1.1.3 1 1 1-101 tie' danh gia

Cac nhan vien co du sac khoe de dam duong cong viec, khong c6 nhan , vien nao clang mic benh truyen nheem

0,5 0.5 Quan sat thnc te

1.2.3 CO mac !an Blu \fa deo bin hien ghi re ant danh

III.4a 1 1

1.2.4 Dupe dao (go, cap nh4t kiln thtic chtiyen mon va pl .* luat y te

III.4a 2 2 (Klan: Ira sy hieu biet ctia nhein vien)

Teit cá niacin vigil Ave hudn luyen cl"J hieu r5 va thtic hien clang cac 11g1.iyell teic GPP

2 1 2 Kiem Ira ste hieu bill clia nhcin vien. Tilt dilin ?lea khong nam &toy

3

Page 11: m'du s6 19 CONG HOA XA HO1 CHI) NGH1A V1LT NAM DON DE …file.medinet.gov.vn/Data/soytehcm/\soytehcm\Attachments/2017_9/DDK DUOC... · (2) Chi áp dung doi vai co sO san xuAt thuoc,

TT Ni dung Than' chieu

Diem chuan

Diem cOng

Diem Inc Diem dat

Ghi chtli

1.2.5 Co Mai th) hoe nha, Itch sv khi dein X2.'IC veri khoch hang

III.4a 0,5 0.5

1.2.6 GO: hi tnejt thong tin lie nginii Nnh

111.4a 0,5 0.5 CO quy dinh trolly, SOP hoc nOi quy

II I Co Ser Vat Chat: E (lien]

la 2.1 X.ly dipg vii tiliet he:

Dia diem co dinh, rieng biet, khu trung bay bao quan rieng biet dam ha° kiem soat dopy mei truong bao quan thuOc

11.1 2 1

2

Nha thueic co mei trutng rieng biet hoan toan

0,5 Ca vach ngan kin va 161 di rieng

BO tri noi cao rao, thoang mat, an toan, cach xa nguem 6 nhiem

0,5 0.5

Tran nha c6 chong bni 4 0,5 0.5

ToOng va nn nha phang, nhan, de ye sinh, lau lira

0,5

2.2 Dien tich vá be tri : Tang trie.n tich case:

II.2a

Dien tich phO hop vai quy me kinh doanh

1 1

2.3 Khu trumg bay bao quan tea II.2a 2 Diem 2 Neu dien tich thieu 10m2

I I

khong chap thuan

tir 10m2 tit xuong thi chain diem khOng chAp thuan

2.4 Khu trang bay bao quan 20m2 — 29 m2

I

Khu trung bay bao quail 30m2 fro len

2

2.5 CO khu vnc de nguai mua thuoc tip xilic va trao d8i thong tin

II.2a 1 1

2.6 CO voi nuac raa tay cho nhan vien nha tint& va nguai mua (Neu khuAt co bin chi d6n)

11.2b, 2d

0,5 0.5 Khong yeu cu phai 66 tri a caa ra vao

4

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TT NO dung Tham chieu

Diem chufin

Diem ccing

Diem trir Diem dAt

Ghi cho

2.7 Cac boat dOng kit: Neu co to chac pha che theo don thi co pining rieng de pha

4 che, GO nal ra dung et) pha che

11.2b 2 Diem khong chap thuan

Khang pha che

CO khu we rieng de ra le

I I

0,5 0.5 Co the xem xet chap thuan neu 56 al pheng rieng hoe hapingan rieng ra le Mu&

Kim vac ra le each ly vad khu we bao quan trung My

0,5

Neu c6 kho bao quan thi kho dat yeu c'au bao quasi thuoc.

2 Diem khEing chap thuan

Khona t, cO kho

CO khu we tu vAn (Khu vim tu van dam bao dugc tinh rieng tu)

1 1

CO khu we hay pheng tu van rieng (Trong Ithuon yien nha thuoc va thuan tien cho khach) ]

0,5

2.8 my- pham, thgc pham chac Mang, dung cu y te de khu vue rieng, kh8ng anh Inning den thu8c

II.2c 1 1

111 . Trang Hat hi : 15 Arent 3.1 Thiel hi Mu quan thufic

3.1.1 ThiM bi bao quail thu6c: 11.3a, 35

- CO dil ta quay bao quan thuoc - Tit, quay, gia ke de ye sinh, dam bao tharn my

1 1

CO Le, Am ke (cO bleu ,nfret 1 1 chuan) va co ghi chep theo cloi , Nal ban Mu& at anh sang de etam bao cot thao tac dion ra thun Igi va khong nhAtn Ifin

1 1

dnh sang mat tit-1 khong chieu tut tiEp vao nai trtmg bay, ha° quail thuoc

1,5 1.5

5

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TT 1\10i dung Thant chieu

Diem audit

Diem cOng

Diem trir Diem do

Chi chit

3.1.2 Co se c6 thiet bi bao quart de dap ang van yeu du bao quan glti tren nhan

11.3a, 3b

2 Diem khong chap thuan

2 VD: thu6c yeti du bao quail mat hoac Will, phai co tu lanh hoac hOp bdo quail chuyen dung

— Nai ban thu6c &roc duy tri, a nhbet dO dual 30o C, da am bang hoac dual 75% va thea man dieu kin bao quan dm thuoc

2 Diem khong chap thuat

2 Su. ching thiet bi kiem soat nhiet de, dO am (may dieu haa, quat, rney hilt am...)

3.2 Dung en, bao bl ra le vã pha che theo dot :

3.2.1 CO bao bi ra le thuac II.3c I 1 3.2.2 CO bao bi kin khi cho thu6c

kheng can bao bi tiep )(tic true tiep

11.3c I 1

3.2.3 Thu& dOng ngoai va thu6c quail 1j, dc biet duct de trong bao bi de- phan bit

11.3c I 1

3.2.4 Thuac ban le kheng dung trong bao bi mang ten thu6c khac hoac chira nOi dung quang cao dm met thuoc kith°

11.3c 1 1

3.2.5 Thu6c pha elle theo don dung trong bao bi duct dung

11.3c I Kheng pha che

3.2.6 Dung cu ra le vá pha che theo don pita hap, a lau rim, lam ve sinh

II.3d 1 Khong pha che

3.2.7 CO thiet hi tiet trnng cac dung cc! pha che 'Ulu& theo don

II.3d 1 Khong, pha che

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TT Nei dung Than] chieu

Diem chuan

Diem cling

Diem trir Diem dal

Ghi chit

IV Chi nhan thu6c: 2 diem 4.1 Thu& ban le khong can bao hi

ngoai dm think &roc nth kern then cac thong tin sau: r -TEn 1111160, dang It che -Nang de, ham luang Neu can (VD: IthOng c6 don thuac, khong co to HDSD neu ban sA luong gua it) phai cO them thOng tin: -Cach clang -Lieu dung -SO in dang

II.3d 1 1

4.2 ThuAc pha che' theo don, ngoai guy dinh nhu pi-Ian 4.1, c6 cac thOng tin sail:, -Ngay pha che -Ngdy het han sir clang -Ten benh nhan -Ten, dia chi nai pha che -Canh bao an toan cho trA em (neu c6)

II.3d 1 K hang pha chE

V ha so s6 sach vil tai lieu chuyen men: 17 diem 5.1 Ha soi phap IY :

5.1.1 Cat gity ter phap 15, nhu DKKD, chang chi hanh ngh6 dm DS Om trach chuyen m6n, GCNDDKKDT (d6i voi c0 sâ clang boat clAng)

1.1 2 Diem khong chap thuan

2

5.1.2 CO he so nhan vier). (HA so ,gam: HDLD, GCN sat khOe, bang cap chuyen mon, so yeti ly Ilich, cac chirng chi dao tat)

1.3 1 1

5.2 Tai _lien hutg an sir cinng think :

5.2.1 CO tai lieu huong an sir dung 'Ulu&

11.4a 1 1

5.2.2 CO cac guy ch' chuyen mon d- II.4a 1 1 acre hien hanh

5.2.3 Co Internet cte tra dm thong tin 1 5.3 116 sty so sach lien quan hot

Ong kinh duanh thaw:

7

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TT Nei dung Tham chieu

Them chufin

Diem ceng

Diem trir Diem dat

Chi elni

5.3.1 Theo MI sO1o, han dOng thu rec va cac van de co lien quan : -Theo del bang may tinh -Theo doi bang se , -Theo doi viec pha che theo don (Mu co). CO s6 pha die

II.4b I I 1 Ceng them I diem neu M so day cle hoac theo del cle tren rnay tir,h

Lau gill he so so sach it nhat I nam ke tir khi thu8c het hari clang

1 1

5.3.2 CO theo dal der lieu lien quail den benh nhan: don thulic hoac benh nhan can hru 9 (Theo ,diii bang May tinh hoac bang so)

II.4b 1 1

• Ho so, s8 sach c6 the tra cau kip 'alai khi can thiet

1 1

5.4 Xay clang vã thut hien clic quy trinh thao lac chuan :

5.4.2 CO de ,cac quy trinh ca ban theo yeu cau (Nei dung quy trinh dung vã phi] hop vol heat Ong dm nha thuoc):

I14.c

Quy trinh mua thu6c va kiem seat chAt Mang

I 1

Quy trinh ban thu6c theo don 1 1

Quy trinh ban thu6c kh6ng Ice don

I 1

Quy trinh bao quan va theo dOi chat luang

I 1

Quy triph giai quyet vol thu6c hi khieu nal hoac thu hei

I

5.4.3 CO cac quy trinh khac (Ghi cg the)

II.4c

5.4.4 Cac quy trinh than tac chuan dia.‘ ca so do pgtrai c6 thAm quyen phe duyet vá ky ban hanh

Phg lye 2

I 1

5.4.5 Nhan vien ban thuoc ap Ming thgc hien dAy du cac quy trinh

II.4c 2 2 Kiem tra kien thirc va cac thao tac thgc hi'en quy trinh

VI Ngue 1.tlitiee: 3 diem

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TT I NOi dung I

Tham chief.]

Diem chufin

Diem eeng

Diem till. Diem dat

Ghi eh a

6.1 CO he so cac nha cung nog thu6c co uy tin gem - Ban sao GCN da clieu kian kinit doanh thuec - CO danh muc cac mat hang cung Ong

III.la 1

CO Jim boa don mua hang hop le

1 1

Tat cil thaw. tai nha thunc IA dm& dirge phop Mu hanh hop pimp (co SDK, hoac co so giay phap nhap khan)

2 Diem kheing chap thuan

2

6.2 • Nha thu6c c6 thy di cac loai thuac dang cho tuyen C trong Danh muc thuoc thiet yeu Viet Nam

111.1d 0,5 Kiam tra xac xua: mat s6 thu6c trong danh muc

- VII ThIre hien gay elle Chuyen men L THyt hanh ngheYnghieffi 18 diem 7.1 Quail ly Mu& eay nghian, thu6c

huemg tam than Iva tin chat theo may dinh

I I

III.4a 1 I Killing KD

Viac bAo quail, kiem ke, bao cao dinh k5', b/cao dot xuat va bao cao xin hOy Milk..

7.2 Mua ban thu6c gay nghien, thu6c htrOng tam than dung quy che

111.4a 1 1 Kheng KD

Dv tra, trinh de chuyen mon dia nguti ban, so sach theo del...

7.3 Kiem tra deli chieu se Itrong thu6c GN, thu6c HTT, tin chat tren sa sach \a. thnc -re khop

111.4a 1 2 Kheng KD

7.4. Nhcin vien nha thuac ?tam claw quy chi ke don va Hit cdch tra C1:114 danh mac thuoc khong ke don

111.4a 1 1

7.5 Khi ban Muck, ngweri ban le co hen ngutai mua cac thong tin ve trieu chang be-nh, ve .tinh trang ngwoi dung thulac de tranh rid ro khi clang thuoc

111.2a 1 1 Trong SOP, theo dei hoot Ong Mut re, h6i nhan 'ien

7.6 Nguti ban le cO,trinh de chuyen mon phi] hop de ban cac thuoc

III.2c 1 I

9

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TT Nei dung Tham chieM

Diem chuin

Diem Ong

Diem ft& Diem dat

Ghi chti

ke trong don thueic

C6 kiem tra don thu6c tarot kill ban

1 1

Nha thu6c c6 bin phap theo dOi viec ban thuoc ke don

1

Neu dun thuoc killing hop le, notal ban thuac ca.. - Iki lai ncuai Ice don - Thongbcio cho ngzzal mua - Ti) choi ban

I 1 C6 so theo dol.

Chi Doge sy dai hoc dugc thay the Cm& trong don thuoc.

1 1 SOP, nhan vi &1 NT nam duoc SOP

7.7 Khi ban thuoc, nguai ban le c6 tu: van va theng bao cho nguai mua: - Lua ch9n thu6c pha km nhu cau diet] tri va kha nang tai chinh - Cach dung thuoc - Cat: thong tin ve thuoc, tac dung phi), tuang tac thu6c, cac canh bao - Nhe.:ng twang hop can so chan doan cilia thAy thuoc mai dung thu6c - Nhang truemg hop khong can sir dung thulic

111.2 1 1

7.8 HuOngI dan sir dung thuoc vim . bang lett n6i, vim ghi nhan theo

quy dinh ,

III.2a I 1

7.9 Khi g4i4 thuoc cho ngtrai mua, ngueri ban le thuilic c6 kiEm tra cloi chieu cfic thong tin sau: - Nhan thuoc - Chat luong thuoc bang ckn quan - ChUng loai that - So lacing

111.2a I 1

7.10 Ngteri ban le, ca so. ban le Ichong ben hanh cat hoat Ong thong tin, quails cao thuac trai voi quy dinh ye thong tin, pang cao

III.2b 1 1 Kiern tra cac ter mu i quang cao, viec dan quang cao...

Ngulai ban le thuoc khong khuxen khich pp.& mua mua nhieu thuoc han can thiet

1 1

10

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TT Ni dung Tham chien

Diem chufln

Diêm7 cQng

Diem frit. Diem dat

Chi din

7.11 Thu& co, (16 nhan 111.1c I1 7.12 Nhan thu5c va thuoc ben trong

dung va khop yen nhau 111.10 I 1

7.13 Sap xep thuoc: - Sap xep gpn gang, de- lay, tranh nham Ian , - Sap xep theo dieu kien bao quasi ghi trEn nhan - CO khu vut rieng cho 'Thu& ke don"

111.3 1 1

7.14 Time hien niem yet gia thu5c dung quy dinh va ban khOng cao han gifl niem yet

,

111.46 1 1

VIII Kiem tra/ dam NM chat Mono- think: 5 (Tem 8.1 CO kiom tra, kiem soat khi nhap

thuOc: - Han ding cua thuOc -ThuOc con nguyen ven , trong bao El get dm nha san xuat , - Cac thong tin ten nhan thuOc (theo yeti cau quy che nhan) , - CO kiem sok chat lupng bang cam quan.

111. lc va 111.1d

2 1 2 Klein Ira SOP va kiem tra Mix te

Co tin hanh kiem soot chat 1- trgng thuOc dinh kj, vã dOt xuat

1 1 1 K.tra so KSCL thuOc

8.2 Tai Mai diem kiem tra khong phat hie'n cat loai thuoc saw - Thu& khemg duct luu hanh - Thu& qua han dung , , -Thu6c kheng TO nguen goo xuat xa. - Thuk gay nghien (dOi vol co sà kheng duct phep ban) - Thu& huang tam than (DOi voi co sa khemg dupt duyet mua) , - Thu& bi dinh chi va thu heti nhung khOng duct phat hien vã kheng bit trn

111.1c 2 Diem khong chap thuan

2

IX Giai 9uyet deti vai thaw bi !alien nai ilOriC thu6c phi tint WO 6 diem - 9.1 CO tiep nhan tliOng tin hoc luu

cac thong bac) ye thuOc khieu nal, thuOc khong duct phep Mu hanh, thuOc Oa.' thu h6i

III.3c 1 1 Ktra so theo doi va tat b/c luu

11

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TT Ni dung Tham &Neu

Dieni ehufin

Diem &Ong

Diem trir Diem dkti

Ghi chti

9.2 CO' tin MI va lap he so thu hi theo guy dinb, Co kiem ,ke del viil thutic khieu nai, thutic phai thu hei(N?u den k9 K.ke than thu hOi chin duct xir 19).

111.3c 1 1 Kira Bban kick', ho so bru

9.3 CO thong hao thu luit cho khcich hang

I11.3c 1 1 Thong bac) ten bang tin, bang thu., din thoai...

9.4 Co tra lqi 170i mua hoac hu.}) 111.3c 1 1 CO he so luu 9.5 Co boo cat) coo cap theo quy

clinh !11.3c 1 1 CO he so bru

9.6 CO so va co ghi chep theo doi Mc dung phi cin thuoc do khach hang [than anh

I11.3b I 1

T8ng cOng 90 0 0 90

Dai dien Doan kiem tra Dai dien ca so-

DS. Tr'an Thi t-

12