Decision No. 4945/2001/QD-BYT on announcing the third supplementary list of 2001 including five foreign enterprises registered to operate in pharmaceuticals and medicinal ingredients in Vietnam.

Pursuant to …;

Regarding the announcement of the Supplemental List for the third round in 2001 comprising five foreign enterprises registered to operate in pharmaceuticals and medicinal ingredients in Vietnam

Registering activities related to pharmaceuticals and medicinal ingredients in Vietnam

_____________________________

 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 No. 17/2001/TT-BYT dated August 1, 2001 of the Ministry of Health guiding foreign enterprises to register their activities related to pharmaceuticals and medicinal ingredients in Vietnam;

Considering the minutes of the meeting of the Board examining foreign enterprises engaged in pharmaceutical trade under the Ministry of Health;

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

Pursuant to …;

Article 1. Announce five foreign enterprises registered to operate in pharmaceuticals and medicinal ingredients in Vietnam (attached list).

Article 2. Foreign enterprises registered to operate in pharmaceuticals and medicinal ingredients in Vietnam 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. Shall bear full responsibility before state management agencies and consumers for the quality of drugs supplied to Vietnam. Compensate consumers and Vietnamese partners for losses caused by the enterprise's fault according to the provisions of the law.

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

6. Report to the Ministry of Health of Vietnam (Drug Administration of Vietnam) when there are changes and submit relevant legal documents in the following cases:

a) Change of General Manager or the person primarily responsible for pharmaceutical and medicinal ingredient activities.

b) Termination of business operations in the field of pharmaceutical 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 enterprise 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 caused by the use of drugs supplied by the enterprise to Vietnam. Report to the Adverse Drug Reaction Center about drug side effects.

Article 3. Foreign enterprises must bear responsibility under Vietnamese law for any violations committed 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 shall take effect fifteen days from the date of issuance.

Article 6. You are hereby instructed to implement this Decision: Heads of the Office, Inspector-General, Directors of relevant Departments under the Ministry of Health, Director of the Drug Administration of Vietnam, Directors of Provincial Health Services, Directors of direct import-export pharmaceutical enterprises, and Directors of foreign companies specified in Article 1.