b) Drug testing facilities include the National Institute of Drug Quality Control, Institute of Drug Quality Control of Ho Chi Minh, Center for Quality Control of medicines of the military; Centers for Drug Quality Controls of provinces certified satisfactory to the Good Laboratory Practice by the Ministry of Health or ISO/IEC 17025 (refer to the list attached hereto).

c) Drug samples shall undergo full quality testing according to the registered drug quality standards and general compulsory testing according to respective types of drugs (e.g. testing of invisible particle limits of injectable drugs).

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3. Removal of name of drug manufacturers from the List shall be conducted as follows: After 06 months from the date on which severity level III violation(s) is committed or   after 01 year from the date on which  severity level I or II violation(s) is committed by a drug manufacturer or after 01 year from the date on which a drug manufacturer has at least 02 shipments certified satisfactory, removal of its name from the List shall be considered if it does not commit any violation during the consideration period,  even in the case of voluntary recall of unsatisfactory drugs.

The aforesaid consideration period shall be calculated from the date on which the Drug Administration publishes the name of those drug manufacturers on the List.

4. Drug importers and testing facilities participating sampling shall submit reports using the form published on the Drug Administration‘s website in “Quản lý chất lượng thuốc” (“drug quality control”) menu in the last week of every quarter. Physical reports shall be submitted to the Drug Quality Control Department – Drug Administration located in 138AGiang Vo, Ba Dinh, Hanoi and electronic reports shall be  sent to pqlcl.qld@gmail.com.

5. Violations during inspection of quality of imported drugs shall be dealt with in accordance with Article 34 of Circular No.09/2010/TT-BYT dated April 28, 2010 by the Ministry of Health providing guidelines for drug quality control and current regulations on pharmaceutical management.

Any issue arising in connection with implementation should be reported to the Drug Administration of Vietnam via telephone number 04.3.846.2010.

PP.DIRECTOR
DEPUTY DIRECTOR




Do Van Dong

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(Issued together with the Official Dispatch No.3256/QLD-CL dated March 05, 2014 by the Drug Administration of Vietnam)

No.

Name of facility

ISO/IEC 17025

GLP

1

Center for Drug Quality Control of Binh Duong province

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Center for Drug Quality Control of Can Tho

x

3

Center for Drug Quality Control of Dong Nai

x

4

Center for Drug Quality Control of DakLak

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5

Center for Drug Quality Control of Gia Lai

x

6

Center for Drug Quality Control of Hanoi

x

x

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Center for Drug Quality Control of Kon Tum

x

8

Center for Drug Quality Control of Nghe An

x

9

Center for Drug Quality Control of Phu Tho

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10

Center for Drug Quality Control of Quang Ngai

x

11

Center for drug Quality Control of Thai Binh

x

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Center for Drug Quality Control of Thanh Hoa

x

x

13

Center for Drug Quality Control of Thua Thien - Hue

x

x

14

Center for Drug Quality Control of Tien Giang

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15

Center for Drug Quality Control of Ho Chi Minh

x

16

Center for Drug Quality Control of Tuyen Quang

x

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Center for Drug Quality Control of Vinh Long

x

18

Center for Drug Quality Control of Vinh Phuc

x

x

19

Institute of Drug Quality Control of Ho Chi Minh

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x

20

 National Institute of Drug Quality Control

x

x

21

Center for drug Quality Control of Hai Duong

x

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Center for Drug Quality Control of Binh Thuan

x

23

Military Center for Drug Quality Control – Medical Service Corps

x

ANNEX

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[Name of governing body
Name of Institute/Center/Department of Drug Quality Control/Drug importer]

THE SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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 No:……………../…………….

REPORT ON SAMPLING FOR INSPECTION OF IMPORTED DRUG QUALITY

To: The Drug Administration – Ministry of Health

Pursuant to the Official Dispatch No.13719/QLD-CL dated August 23, 2013 and Official Dispatch No.3256/QLD-CL dated March 05, 2014 by the Drug Administration of Vietnam, ……………..[name of reporting entity and telephone number]……………….. hereby reports on quality of imported drugs inspected from……………….to……………..as follows:

Name and address of drug manufacturer

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Name of drugs (form)

Registration/ Import license No.

Shipment number, date of manufacture (if any), date of expire

Packaging specifications /unit (smallest packaging unit)

Quantity of imported drugs (*)

Name and telephone number of registering facility (*)

Name and telephone number of importer

Name and telephone number of entrusted importer (if any) (*)

Name and telephone number of class I distributor (if any) (*)

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Name, telephone number of sampling entity and testing entity

Date of sampling

Date of issue of drug quality testing form

Testing results (satisfactory/unsatisfactory)

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(*): Sampling facilities and testing facilities are not supposed to report on such contents.

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- ………(quantity of copies) Sampling record (for unsatisfactory samples));

- …..………(quantity of copies) testing form (for unsatisfactory samples));

…………………………[Location and date]………..
[Head of reporting entity]
(Sign and seal)