Decision No. 3649/2001/QD-BYT on announcing the second batch supplementary list for 2001 including 6 foreign companies registered to operate in pharmaceuticals and medicinal ingredients in Vietnam.

Pursuant to …;

Regarding the announcement of the Supplemental List for the second round in 2001, including 6 foreign companies.

Registering activities related to pharmaceuticals and medicinal ingredients in Vietnam

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 THE MINISTER OF HEALTH

Based on the Law on Health Care for the People dated July 11, 1989;

Pursuant to the Pharmaceutical Ordinance for Disease Prevention and Treatment issued pursuant to Decree No. 23/HĐBT dated January 24, 1991 of the Council of Ministers (now the Government);

Pursuant to Circular 07/BYT-TT dated March 30, 1991, issued by the Minister of Health, guiding the registration process for foreign companies permitted to import and export pharmaceutical raw materials with organizations and companies in the Socialist Republic of Vietnam.

Considering the minutes of the meeting of the Council for Pharmaceutical Business Enterprises of the Ministry of Health.

At the proposal of the Director of the Drug Administration of Vietnam.

Pursuant to …;

Article 1. Announce the list of six foreign companies registered to operate in pharmaceuticals and raw materials for pharmaceuticals in Vietnam (the list of six foreign companies attached hereto).

Article 2. The foreign companies specified in Article 1 shall be responsible for the following:

1. Strictly comply with the laws and regulations of Vietnam, as well as the management regulations of the Ministry of Health and the Drug Administration of Vietnam.

2. Shall not supply to Vietnam any drugs that are not permitted to circulate in Vietnam, counterfeit drugs, or substandard drugs.

3. Shall not distribute drugs directly in Vietnam in any form.

4. Bear full responsibility before state management agencies and consumers for the quality of drugs supplied to Vietnam. Compensate consumers and Vietnamese partners in cases of damage caused by the company's fault according to the provisions of the law.

5. Report annually to the Ministry of Health of Vietnam (Drug Administration of Vietnam) on drug trading activities with Vietnam.

6. Report to the Ministry of Health of Vietnam (Drug Administration of Vietnam) in case of changes and submit relevant legal documents in the following situations:

a. Change of General Manager or the person primarily responsible for pharmaceutical business and raw materials.

b. Cease operations in the field of drug trading with Vietnam.

c. Merger or division of the enterprise.

7. Foreign enterprises shall have the responsibility to report promptly in the following cases:

a. When requested by competent authorities.

b. Report to the Ministry of Health (Drug Administration of Vietnam) when discovering that drugs supplied by the company to Vietnam do not meet quality standards or violate other professional regulations.

c. Report to the Ministry of Health (Drug Administration of Vietnam) when discovering serious adverse events due to the use of drugs supplied by the company to Vietnam. Report to the ADR Center about harmful drug reactions.

Article 3. Foreign companies must bear legal responsibility under Vietnamese law for their violations during their operations in Vietnam.

Article 4. The permit is valid for two years from the date this decision takes effect.

Article 5. This Decision takes effect fifteen days from the date of issuance.

Article 6. The officials: Chief of the Office, Inspector General, Heads of relevant Departments of the Ministry of Health, Director of the Drug Administration of Vietnam, Directors of Provincial Health Services, Directors of enterprises directly involved in importing and exporting drugs and raw materials, and Directors of foreign companies specified in Article 1 are responsible for implementing this Decision.