Công văn 13719/QLD-CL của Cục Quản lý Dược về việc kiểm tra chất lượng thuốc nhập khẩu

THE MINISTRY OF HEALTH
THE DRUG ADMINISTRATION OF VIETNAM

Official Dispatch No. 13719/QLD-CL dated August 23, 2013 of the Drug Administration of Vietnam on quality examination of import drugs

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:

1.  To request the drug importers for: Coordinating with the system of quality control to examine 100% of import drug lots from companies in the enclosed list of foreign pharmacy companies providing drugs violating quality (this list is updated quarterly and notified on the website of the Drug Administration of Vietnam) before circulating on market, specifying as follows:

- 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; 

+ To send the taken samples to the Central drug testing institution; Ho Chi Minh city drug testing institution or testing center of province or city for quality examination;

+ 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.

- Being permitted to put into circulation, distribution of drug lots which have been taken samples and tested for satisfying quality criteria. In the course of circulation, they still continue following up and supervising the drugs quality in accordance with regulation.

- 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.

- To further implement content of the official dispatch No. 8121/QLD-Clause dated May 29, 2013, of the Drug Administration of Vietnam, on examination, supervision of quality of drugs circulated on the market.

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

- Directing the testing centers in:

+ Coordinating with drugs importers to carry out the taking of drug sample for quality test.

+ 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.

- Handling violations under their competence. Reporting to the Ministry of Health (the Drug Administration of Vietnam) to serve as basis for consideration and additional handling of violations of foreign drug producers as well as drug importers.

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.

The Director of Drug Administration of Vietnam

Tran Quoc Cuong