Декрет - Вьетнам (2022)

e) Danh muc cac mat hang dang san xuat;

g) Danh muc cac quy trinh thao tac chuan;

h) Bien ban tu thanh tra va danh gia cua co so trong dot tu thanh tra gan

nhdt (trong vong 03 thang) v6 tri£n khai GMP.”

3. Sua ddi, bd sung khoan 1 Dieu 16 nhu sau:

“ 1. H6 so, trinh tu, thu tuc cap lai Giiy chung nhan GMP trong truong hop

bi mat, sai sot, hu hong; thay doi thong tin co lien quan den to chuc dang ky.

a) To chuc, ca nhan nop 01 bo ho so cdp lai Gidy chung nhan GMP toi

Cue Thu y theo mot trong cac hinh thuc: true tuyen hoac qua dich vu buu

chinh hoac true tidp. Hd so gom: ban chinh don dang ky cap led va ban chinh

hoac ban sao cd chung thuc hoac ban sao cd dong dau xac nhan cua Doahh

nghiep cac tai lieu: tai lieu chung minh ndi dung thay ddi trong truong hop

thay doi thong tin cd lien quan den to chuc dang ky; Giay chung nhan GMP

da duoc cap, tru truong hop bi mat;

b) Truong hop hd so khdng ddy du va hop le, trong thoi h^n 03 ngay lam

vide ke tu ngay nhan hd so, Cue Thu y cd van ban hudng dan to chuc, ca nhan

hoan thien hd so;

c) Trong thoi han 05 ngay lam vide ke tu ngay nhan du hd so hop Id, Cue

Thu y cdp lai Giay chung nhan GMP hoac cd van ban tra loi va ndu ro ly do

trong truong hop khdng cap.”

Didu 2. Bai bo, thay doi mot so diem, khoan cua Nghi dinh so 35/2016/ND-CP

ngay 15 thang 5 nam 2016 cua Chinh phu quy dinh chi tiet mot so dieu

cua Luat Thu y

1. Bai bo diem b, diem k khoan 1 Didu 14.

2. Thay doi cum tu “Hd so dang ky kidm tra GMP phai cd trang bia va

muc luc, duoc sap xdp theo dung trinh tu cua muc luc, cd phan each giua cac

phdn” thanh cum tu “ Hd so gdm ban chinh tai lieu quy dinh tai cac diem a, c,

d, d, e, g va i khoan 1 Didu nay; ban chinh hoac ban sao cd chung thuc hoac

ban sao cd dong ddu xac nhan cua Doanh nghiep tai lieu quy dinh tai diem h

khoan 1 Didu nay. Hd so dang ky kidm tra GMP phai cd trang bia ya mycjuc,

duoc sap xdp theo dung trinh tu cua muc luc, cd phan each giua cac phan tai