Official Dispatch No. 13719/QLD-CL on regarding quality examination of import drugs

• Số hiệu: 13719/QLD-CL
• Loại văn bản: Công văn
• Nơi ban hành: Cục Quản lý dược
• Người ký: Trương Quốc Cường
• Ngày ban hành: 23/08/2013

THE MINISTRY OF HEALTH THE DRUG ADMINISTRATION OF VIETNAM --------	SOCIALIST REPUBLIC OF VIET NAM Independence – Freedom - Happiness ---------------
No. 13719/QLD-CL Regarding quality examination of import drugs	Hanoi, August 23, 2013

Respectfully to:

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In the recent time, through examination and supervision of drug quality, agencies managing and examining drug quality have detected and notified revocation of several drug lots which fail to satisfy quality criteria, in which there are many import drugs.  In order to strengthen provision of quality drugs in serve of disease prevention and treatment for the people, the Drug Administration of Vietnam has opinions as follows:

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- After drugs are granted customs clearance, drugs must be transported for preservation at warehouses satisfying standards “Good Storage Practice” (GSP):

+ To contact with the Testing Center of province or city to come for taking sample to test quality as prescribed in Circular No. 04/2010/TT-BYT dated February 12, 2010, of the Ministry of Health, guiding on taking sample of drug for defining quality applicable to 100% drug lots imported from those companies mentioned above; 

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+ Together with drugs suppliers, to take responsibility for provision of base substances, reference substances, base mixtures for testing drugs at the request of the testing unit.

+ To take responsibility for payment of the testing charges in accordance with current regulations of State for drugs samples send to for the quality testing.

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- Quarterly, to report the quality testing of import drugs to the Drug Administration of Vietnam (the model report prescribed in the enclosed Annex).

2. To request the Central drug testing institution; Ho Chi Minh city drug testing institution and testing centers of provinces and cities for:- Testing quality of drugs send by importers before putting them to circulation, distribution and use. In order to serve timely production and business, time for answering result of testing will be 15 working days after the testing system receives full samples and requirements related to the quality testing of drug lots.

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3. To request the Health Departments of provinces and central affiliated cities, Health agencies of sectors for:

- Directing the testing centers in:

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+ Testing drug samples in ability, capability of the testing centers or sending samples to the testing institution at the request of drugs importers.

- Examining, supervising the strict implementation of taking sample and testing drugs quality of the drug importers placed in localities before putting them into circulation, distribution and use as guided at this official dispatch.

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4. This official dispatch is performed from October 01, 2013. The Drug Administration of Vietnam shall assess specifically result of implementation of the contents mentioned above and have the next guide for conformity with the practice conditions.

The Drug Administration of Vietnam notifies and requests units for strict and expeditious implementation. In the course of implementation, any arising problems should be reported to the Drug Administration of Vietnam for guiding settlement.

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DIRECTOR OF DRUG ADMINISTRATION




Truong Quoc Cuong

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