BO Y TE CONG HOA XA HOI CHU NGHIA VIET NAM CYC QUAN LY DUQC Doc lip - Ty do - Hanh phic 8: 3/5 /QLD-CL Ha N6i, ngay 49 thing 4 nam 2018 VW tha hdi thude sin xudt tr nguyén ligu Valsartan do Céng ty Zhejiang Huahai Pharmaceutical — Trung Quéc san xuat (Kinh gir: 4 => -S6-¥ 18 cde tinh, thanh phé tryc thuge Trung wong | -HOA- TOC- - Céc co s6 sn xuét, kinh doanh thuée Sn rude. C&n cit vao.cae quy ché duge hign hanh cua Viét Nam. Can cif théng bao, clia Cor quan quan Iy durge pham Chau Au (EMA), Co quan quan ly duge Canada va mt s6 co quan quan ly duge khée vé vige thu héi cée thude chtta Valsartan duge san xuat tir nguyén ligu Valsartan do Céng ty —— Zhejiang Huahai Pharmaceutical — Trung Quéc san xuat. Nguyén ligu nay duge phat hign chita tap. chat N-nitrosodimethylamine (NDMA) c6 nguy co gay ung thu. é dam bao an toan cho ngudi sir dung, Cuc Quan ly Duge théng bao: 1. Dinh chi luu hanh tat c& cdc thude thanh pham duge san xuat tir nguyén ligu Valsartan do Céng ty Zhejiang Huahai Pharmaceutical — Trung Quée san xuat theo danh myc dinh kém. 2. Yéu cdu cdc Céng ty ding ky thudc, san xudt thudc, Céng ty nhap khi a) Phdi hop véi nha phan phéi thudc théng bao thu héi tat ca cae 16 thude thanh phim trong céng thie sn xuat c6 chtta nguyén ligu Valsartan do Céng ty Zhejiang Huahai Pharmaceutical — Trung Quéc san xuat theo danh mye kém theo t6i cac co sé ban buén, ban |é, sir dung thud va tién hanh thu hdi toan b6 cae 16 thuéc nay. b) Nging ngay vige str dung nguyén ligu Valsartan ca Céng ty Zhejiang Huahai Pharmaceutical — Trung Quéc dé san xuat thude thanh pham. Thye hign danh gid nha cung cap, kiém tra, nghién cttu str dung nguyén ligu Valsartan ciia nha sin xudt méi dam bao yéu cau chat Itong, an toan cho ngwoi sir dung va thyc hign thi tuc thay ddi hé so ding ky thudc theo ding quy dinh cia phap luat. ©) Gti béo cdo thu héi vé Cue Quan ly Duge trong ving 01 thing ké tir ngay ky Céng van nay, hé so thu hdi bao g6m s6 Iuong xuat xudng, sO lugng thu hi, cde bing chimg vé viée thyc hign thu hdi tai cae co sé ban budn, ban Ié, sir dung da mua thudc theo quy dinh tai Théng tr sé 11/2018/TT-BYT ngay 04/5/2018 cia BO Y té quy dinh vé chat lugng thuéc, nguyén ligu lim thude.3. Dé nghj So Y té cac tinh, thanh phd: a) Théng bao viée thu hai téi cdc co sé kinh doanh, str dung thudc trén dja ban, b) Cong bé théng tin viée thu hai 16 tt ca cde thuéc thanh pham duge san xudt tir nguyén liéu Valsartan do Céng ty Zhejiang Huahai Pharmaceutical — Trung Quéc san xuat trén Trang thong tin dién tir cia SO. c) Kiém tra va gidm sat cdc Céng ty san xuat, kinh doanh trén dia ban thye hign viée thu hdi cdc 16 thude néu trén, xir ly cdc don vi vi pham theo quy dinh. Cue Quan ly Duge théng bao dé cae don vi biét va thye hién/. 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