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Official Gazette

Friday, November 24, 2017

Enterprises get go-ahead for habit-forming drug production

Updated: 17:06’ - 03/07/2014

From July 15, enterprises will be allowed to register for production of habit-forming drugs.

Such is provided in the Ministry of Health’s Circular No. 19/2014/TT-BYT of June 2, 2014, on the management of habit-forming drugs, psychotropic drugs and pre-substances used as medicines.

Accordingly, in principle, producers, importers, exporters, wholesalers, retailers or establishments providing services relating to habit-forming medicines, psychotropic drugs and pre-substances used as medicines must comply with provisions on the drug business conditions prescribed in the Law on Pharmacy, the Government’s Decree No. 79/2006/ND-CP of August 9, 2006, and Decree No. 89/2012/ND-CP of October 24, 2012.

Under the Circular, the above-mentioned establishments are required to elaborate and carry out their own standard operating procedures (SOP) on habit-forming medicines, psychotropic drugs and pre-substances used as medicines to manage import, export, purchase, sale, preservation, delivery, receipt, transportation and destruction of such medicines.

Before November 30 every year, establishments wishing to produce habit-forming medicines, psychotropic drugs and pre-substances used as medicines must send a written request to the Ministry of Health’s Drug Administration for consideration and permission.

Storekeepers of these establishments are required to possess pharmacy university degrees with at least 2 years’ experience of working at drugstores or pharmacist shops.-


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