Decision No. 547-TTg establishes the Vietnam Drug Administration under the Ministry of Health to manage state affairs regarding drugs and cosmetics. The Administration is tasked with developing strategies, planning, and plans for the pharmaceutical industry; issuing production, import, and export licenses for medicines; managing information on drug advertising; inspecting and supervising compliance with laws governing drug and cosmetic management.
적용 범위
The Ministry of Health and the Health Departments of provinces and centrally-administered cities
핵심 사항
- The Vietnam Drug Administration has legal personality, its budget funded from the State budget, and its headquarters located in Hanoi.
- The Administration is responsible for developing strategies and plans for the development of the pharmaceutical industry and managing activities related to information and advertising of drugs.
- The Administration decides on issuing, suspending, or revoking production, import, export, and circulation licenses for drugs and cosmetics according to the law.
- The Administration manages the national reserve of drugs and performs state management functions over drugs and cosmetics that directly impact public health.
- The Director and Deputy Directors of the Administration are appointed and relieved of their duties by the Minister of Health.
🌐 이 문서의 사회적 영향
- Positive impact: Strengthening state management over drugs and cosmetics, protecting public health.
- Negative impact: It may cause difficulties in managing the production and business operations of drug enterprises.
❓ 자주 묻는 질문
What are the tasks of the Vietnam Drug Administration?
The Administration manages the strategy and planning for the development of the pharmaceutical industry; develops and promulgates standards and policies on drugs; issues production and import licenses for medicines; manages information on drug advertising.
Who appoints the Director and Deputy Directors?
The Director and Deputy Directors are appointed and relieved of their duties by the Minister of Health.
Does the Vietnam Drug Administration have legal personality?
Yes, the Administration has legal personality, with its budget funded from the State budget.
How does the Administration manage the national reserve of drugs?
The Administration develops plans for the national reserve of drugs and manages this reserve.
What licenses can the Administration decide to issue, suspend, or revoke?
The Administration has the authority to decide on issuing, suspending, or revoking production, import, export, and circulation licenses for drugs and cosmetics according to the law.
전문
| PRIME MINISTER | SOCIALIST REPUBLIC OF VIETNAM Independence - Freedom - Happiness |
| Number: 547-TTg | Hanoi, August 13, 1996 |
Pursuant to …;
Regarding the establishment of the Vietnam Drug Administration under the Ministry of Health.
PRIME MINISTER
Pursuant to the Government Organization Law dated September 30, 1992;
Pursuant to the Government Decree No. 68/CP dated October 11, 1993 on the tasks, powers, and organizational structure of the Ministry of Health, and the Government Resolution No. 37/CP dated June 20, 1996 on the strategic orientation for health care and protection work for the people during the period of 1996-2000 and the national policy on drugs of Vietnam;
At the proposal of the Minister of Health and the Minister, Chairman of the Civil Service Committee of the Government,
DECISION:
Article 1. Establish the Vietnam Drug Administration under the Ministry of Health based on the reorganization of the Department of Pharmacy and other organizations of the Ministry of Health related to drug administration to assist the Minister of Health in performing the specialized state management functions regarding drugs and cosmetics directly affecting the health of the people throughout the country.
The Vietnam Drug Administration has legal personality, its own seal, operational funds provided by the State budget, and is allowed to open accounts at the State Treasury, with its headquarters located in Hanoi city.
Article 2. The Vietnam Drug Administration shall have the main tasks and powers as follows:
1. To develop strategies, plans, and programs for the development of the pharmaceutical industry for submission to the Prime Minister for approval by the Minister of Health, and to implement them after approval.
2. To draft laws, ordinances, regulatory documents, standards, policies, and management systems for the specialized management of drugs and cosmetics for submission to the Government or issuance by the Minister according to their authority.
To issue technical regulations and operational procedures for the management of drugs and cosmetics that directly affect public health according to their authority.
3. To decide according to their authority on issuing, suspending, or revoking permits for the production, import, export, and circulation of drugs and cosmetics as prescribed by law.
4. To develop or participate in developing national stockpile plans for drugs and manage the national stockpile of drugs.
5. To submit to the Minister of Health for issuance regulations on standards and conditions for different types of pharmaceutical practice organizations. Issue, suspend, or revoke certificates of practice for units producing and trading in drugs and cosmetics according to the provisions of the law.
6. To manage information, advertising, and introduction activities for drugs and cosmetics produced in Vietnam or abroad, and issue permits for such activities.
To direct propaganda and guidance on the safe, rational, and effective use of drugs.
7. To inspect and supervise the implementation of laws, ordinances, government regulations, and Ministry of Health regulations on drug and cosmetic management throughout the country.
To take the lead and coordinate with relevant sectors in combating the production, circulation of counterfeit, substandard drugs, illegal imports of drugs, and the abuse of addictive drugs in the healthcare sector.
To handle violations of drug and cosmetic management according to their authority as prescribed by law.
8. To manage the organization, civil servants, staff, and assets assigned according to the regulations of the State.
Article 3. The Vietnam Drug Administration shall have a Director and several Deputy Directors. The Director and Deputy Directors shall be appointed and relieved of duty by the Minister of Health.
The Director shall be responsible to the Minister of Health for all activities of the Administration. The Deputy Directors shall assist the Director and be responsible to the Director for the tasks assigned to them.
Article 4. Provincial Departments of Health shall assist the People's Committees of provinces and centrally-administered cities in performing state management functions regarding drugs and cosmetics directly affecting the health of the people within their respective provinces and cities, and shall be subject to the professional guidance of the Vietnam Drug Administration.
Article 5. The Minister of Health shall be responsible for detailing the organizational structure and staffing of the Vietnam Drug Administration and guiding the organization of provincial drug management after consultation with the Minister and the Head of the Government Organizational Affairs-Civil Service Department.
Article 6. This Decision shall take effect from the date of issuance. All previous regulations contrary to this Decision shall be abolished.
Article 7. The Minister of Health, Ministers, Heads of ministerial-level agencies, Heads of agencies under the Government, Chairmen of People's Committees of provinces and centrally-administered cities shall be responsible for implementing this Decision.
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PRIME MINISTER |
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