Decision No. 53/2008/QD-BYT stipulates the functions, tasks, powers, and organizational structure of the Drug Administration under the Ministry of Health.

Pursuant to …;

||| Regulations on functions, tasks, powers, and organizational structure of

The Drug Administration under the Ministry of Health

THE MINISTER OF HEALTH

Pursuant to Decree No. 178/2007/NĐ-CP dated December 3, 2007 of the Government stipulating the functions, tasks, powers, and organizational structure of Ministries and ministerial-level agencies;

Pursuant to Decree No. 188/2007/NĐ-CP dated December 27, 2007 of the Government on the functions, tasks, powers, and organizational structure of the Ministry of Health;

Considering the proposal of the Director of the Personnel Department and the Director of the Drug Administration, Ministry of Health.

DECISION:

Article 1. Position and Functions

1. The Drug Administration is a specialized agency under the Ministry of Health, assisting the Minister of Health in performing state management functions and organizing the implementation of laws, directing and managing professional activities in the field of pharmaceuticals and cosmetics nationwide.

The Drug Administration has the English name: Drug Administration of Vietnam, abbreviated as DAV.

2. The Drug Administration has legal personality, its own bank account and seal, with its main office located in Hanoi city. The operating funds of the Administration are provided from the State budget and other legitimate sources.

Article 2. Tasks and Authorities

1. To take the lead or participate in building strategies, policies, plans, and development programs for the pharmaceutical industry in Vietnam to submit to the Minister of Health for approval or to the Prime Minister for approval through the Minister of Health, and organize the implementation after approval.

2. To take the lead or participate in drafting normative legal documents and professional regulations on pharmaceuticals and cosmetics to submit to the Minister of Health for issuance or to competent authorities for issuance; issue technical guidance documents within its authority regarding pharmaceuticals and cosmetics; direct, guide the organization of implementation and inspect the implementation of normative legal documents, regulations, and management systems on pharmaceuticals and cosmetics nationwide.

3. To issue, suspend, revoke certificates of good manufacturing practice (GMP), good laboratory practice (GLP), good storage practice (GSP), good agricultural and collection practice (GACP), drug marketing permits; export and import drug permits, and other related management areas.

4. To take the lead or coordinate with relevant agencies to submit to the Minister for decisions on clinical trials for drugs registered for circulation and importation into Vietnam; coordinate with the Science and Training Department to develop, amend, and supplement regulations on clinical drug trials to be issued by the Minister and organize guidance on their implementation.

5. To take the lead or coordinate with relevant agencies in managing information and advertising for drugs and cosmetics.

6. To take the lead or coordinate with relevant agencies in implementing state management over drug prices and market stabilization measures within its authority.

7. To organize reviews and inspections to submit to the Minister of Health for issuing, suspending, or revoking pharmacy practice certificates for individuals practicing pharmacy with foreign investment capital; certificates of eligibility to operate pharmacies for production facilities, service storage facilities, testing services, and registration activities of foreign enterprises supplying drugs to Vietnam.

8. To perform state management functions over the quality of drugs and cosmetics. Coordinate with drug and cosmetic testing agencies and relevant agencies to manage the quality of drugs and cosmetics. Decide according to its authority on suspending circulation and recalling drugs and cosmetics in accordance with the law.

9. To take the lead or coordinate with the Inspectorate and other relevant agencies to inspect and audit compliance with legal provisions on drug and cosmetic management; prevent and combat the production and circulation of counterfeit drugs and cosmetics, substandard drugs and cosmetics, and smuggled drugs and cosmetics; prevent and combat the abuse and loss of narcotic drugs, psychotropic drugs, and precursor chemicals used in healthcare; handle violations of drug and cosmetic laws within its authority.

10. To organize and manage activities related to pharmacovigilance, monitoring adverse effects, and other information related to drugs and cosmetics; direct the implementation of drug and cosmetic information and advertising work nationwide.

11. To take the lead or coordinate with the Medical Examination and Treatment Administration to implement hospital pharmacy work; coordinate with the Traditional Medicine Department to guide the use of traditional medicine and herbal medicines in medical institutions.

12. To be responsible for the standards, quality, and types of drugs and raw materials for drugs in the National Drug Reserve list and coordinate with relevant agencies and units to implement them; coordinate with the Planning and Finance Department to review and provide comments on tender plans for central hospitals and projects under the Ministry.

13. To serve as the permanent body of the Enterprise Reform and Development Board under the Ministry of Health.

14. To build plans and organize the implementation of international cooperation activities in the fields of pharmaceuticals and cosmetics.

15. To manage organizations, civil servants, officials, employees, assets, and allocated funds in accordance with the law.

16. To perform other tasks assigned by the Minister of Health.

Article 3. Organizational Structure and Operational Mechanism

1. Leadership of the General Department

The Director and Deputy Directors of the General Department are appointed and relieved from duty by the Minister of Health. The Director is responsible to the Minister of Health and the law for all activities of the General Department. The Deputy Directors assist the Director and are responsible to the Director and the law for the tasks assigned to them.

2. Organizational Structure of the General Department

a) Office of the Department;

b) Planning and Finance Department;

c) Drug Business Management Division;

d) Pharmaceutical and Cosmetic Quality Management Division;

đ) Drug Registration Division;

e) Pharmaceutical and Cosmetic Information and Advertising Management Division;

g) Legal Affairs and Integration Division;

h) Pharmaceutical Price Management Division;

i) Subordinate Units of the General Department:

- Pharmaceutical and Cosmetic Magazine;

- Comprehensive Training and Guidance Center for Pharmaceutical and Cosmetic Quality Management;

3. Operational Mechanism

a) The General Department of Medicine operates under the head system;

b) The functions, duties, and authorities of the General Department's Office and its divisions are defined by the Director based on the tasks assigned by the Minister of Health. The relationships between divisions within the General Department and subordinate units are also defined by the Director;

c) The appointment and removal of leadership positions in the General Department's Office and its divisions are carried out according to current regulations;

d) Leaders of the General Department, leaders of the General Department's Office, and leaders of its divisions shall enjoy allowances as stipulated by current regulations.

4. Staffing

The staffing of the General Department of Medicine is determined by the Minister of Health's Decision and adjusted annually based on work needs proposed by the Director.

Article 4. Effective date

This Decision takes effect fifteen days after its publication in the Official Gazette.

Article 5. Responsibilities for Implementation

The Permanent Secretaries of the Ministry, the Inspector General of the Ministry, the Directors of the Departments, and the Heads of related agencies, organizations, and individuals are responsible for implementing this Decision./.