Công văn 3256/QLD-CL

Pursuant to the Official Dispatch No.13719/QLD-CL dated August 23, 2013 by the Drug Administration of Vietnam under which drug importers must conduct drug quality inspection before selling drugs imported from foreign pharmaceutical manufacturers on the List of foreign pharmaceutical manufacturers whose medicines fail to meet Vietnam’s quality standards (hereinafter referred to as “the List”); In order to ensure  synchronous implementation, the Drug Administration of Vietnam hereby gives instructions in regard to drug sampling, sample delivery and inspection of quality of the whole drug shipment (hereinafter referred to as “sampling and testing”) imported from foreign pharmaceutical manufacturers on the List and take actions against violations as follows:

1. A pharmaceutical manufacturer shall carry out sampling and testing of imported drugs under the Official Dispatch No.13719/QLD-CL from the date on which the Drug Administration publishes the list of foreign pharmaceutical manufacturers having unsatisfactory drugs if its name is included on the list. The Drug Administration shall monthly update and make this List publicly available.

2. Drug sampling and testing as requested in the official Dispatch No.13719/QLD-Clause shall be carried out as follows:

a) Drug sampling facilities include a drug quality control agency of the State’s drug quality control system (the National Institute of Drug Quality Control, Institute of Drug Quality Control of Ho Chi Minh or Centers for Drug Quality Controls of provinces).

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).

Where a Center for Drug Quality Control is not capable of running all the mandatory tests or a drug needs to undergo certain tests beyond the GLP or ISO/IEC 17025, the drug sample shall be delivered to the National Institute of Drug Quality Control or Institute of Drug Quality Control of Ho Chi Minh to undergo such tests. Importers shall provide reference substances and necessary chemicals upon request of Institutes of Drug Quality Control.

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 [email protected].

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.

OF DRUG QUALITY CONTROL FACILITIES CERTIFIED SATISFACTORY TO GLP ISO/IEC 17025 AND STANDARDS

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

ANNEX

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

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:

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

Attached documents:

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

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