Decision No. 3649/2001/QD-BYT of the Minister of Health announces the list of 6 foreign companies permitted to operate in pharmaceuticals and medicinal ingredients in Vietnam, and specifies their specific responsibilities and obligations.
适用范围
6 foreign companies registered to operate in pharmaceuticals and medicinal ingredients in Vietnam.
要点
- Foreign company → must comply with Vietnamese laws, shall not provide prohibited, counterfeit, or substandard drugs, and shall not directly distribute drugs in Vietnam.
- Foreign company → is responsible for the quality of the drugs it provides and shall compensate for damages caused by its fault.
- Foreign company → shall report annually to the Ministry of Health on drug trading activities, as well as report when there are changes or discoveries of non-compliant drugs.
- Foreign company → shall be liable under Vietnamese law for violations committed during operations in Vietnam.
- The operating permit of the foreign company → is valid for two years, starting from the date this decision takes effect.
🌐 本文件的社会影响
- Positive impact: Recognition and strict management of foreign companies' activities in the pharmaceutical sector, protecting consumer rights.
- Negative impact: Legal responsibility burden and reporting procedures for foreign companies.
❓ 常见问题
How can foreign companies operate in Vietnam?
Foreign companies shall not provide unapproved, counterfeit, or substandard drugs, nor shall they directly distribute drugs in Vietnam.
What reports must foreign companies submit to the Ministry of Health?
Companies must report annually on drug trading activities and report when there are changes or discoveries of non-compliant drugs.
For how long is the operating permit of a foreign company valid?
The permit is valid for two years from the date this decision takes effect.
What liability will foreign companies face if they violate regulations?
Companies shall be liable under Vietnamese law for violations committed during operations in Vietnam, including compensation for damages.
When does this decision take effect?
This decision takes effect fifteen days after the date of issuance.
全文
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
_________________________
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.
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