Circular No. 38/2010/TT-BYT guides the inspection of the implementation of state management regulations on pharmaceuticals and cosmetics.

CIRCULAR

Guidelines for inspecting the implementation of state management regulations on pharmaceuticals and cosmetics

______________________________________

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;

Pursuant to the Pharmaceutical Law No. 34/2005-QH11 dated June 14, 2005;

Pursuant to the Decree No. 79/2006/NĐ-CP dated August 9, 2006 detailing the implementation of certain provisions of the Pharmaceutical Law;

Pursuant to the Government's Decree No. 13/2008/NĐ-CP dated February 4, 2008 organizing specialized agencies under provincial People's Committees directly under the Central Government;

Pursuant to the Government's Decree No. 14/2008/NĐ-CP dated February 4, 2008 organizing specialized agencies under district, county, town, and city-level People's Committees under provinces;

The Ministry of Health guides the inspection activities for the implementation of state management regulations on pharmaceuticals and cosmetics as follows:

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation and Applicability

Thông tư này quy định chi tiết khoản 4 Điều 38 Luật Thủy sản số 18/2017/QH14 đã được sửa đổi, bổ sung tại điểm c khoản 21 Điều 14 Luật số 146/2025/QH15.

These guidelines apply to organizations, entities, and individuals involved in pharmaceuticals and cosmetics activities in Vietnam.

Thông tư này áp dụng đối với tổ chức, cá nhân có liên quan đến hoạt động kinh doanh đối tượng thủy sản nuôi chủ lực trên lãnh thổ Việt Nam.

These guidelines apply to organizations, entities, and individuals involved in pharmaceuticals and cosmetics activities in Vietnam.

Chapter II

INSPECTION ACTIVITIES

Article 2. Inspection Authority

1. The Ministry of Health inspects the Department of Health of provinces/cities directly under the Central Government.

2. The Department of Health inspects units subordinate to the Department of Health and units engaged in pharmaceuticals and cosmetics activities within their jurisdiction (including units subordinate to the Ministry of Health and units with foreign direct investment).

Article 3. Content of Inspections at the Department of Health

Inspections of the Department of Health’s state management activities on pharmaceuticals and cosmetics include the following contents:

1. Development planning and implementation of industry development plans at the local level after approval;

2. Guidance on the implementation of national policies on medicines;

3. Promotion and dissemination of new regulatory documents on pharmaceuticals and cosmetics;

4. Implementation and coordination with units to enforce regulatory documents and management regulations on pharmaceuticals and cosmetics;

5. Organization and inter-agency coordination in supervising and inspecting the implementation of state management regulations on pharmaceuticals and cosmetics;

6. Guidance to units on increasing the use of domestically produced medicines;

7. Guidance to units on implementing good practice principles (GPs), particularly Good Pharmacy Practice (GPP);

8. Professional guidance to District Health Departments on pharmaceuticals and cosmetics work within their jurisdictions;

9. Licensing and registration related to pharmaceuticals and cosmetics;

10. Guidance and inspection of units’ compliance with pharmaceutical and cosmetic management regulations by sector:

a) Management of narcotic drugs, psychotropic substances, and precursors;

b) Quality control of medicines;

c) Medicines advertising information management;

d) Medicine pricing management;

đ) Pharmaceutical business management;

e) Drug registration;

g) Medicine tendering and supply;

h) Hospital pharmacy management;

i) Medication information and adverse drug reaction monitoring (DI & ADR);

k) Cosmetics management.

11. Statistics and reporting;

12. Pharmaceutical workforce training;

13. Administrative reform.

Article 4. Content of Inspections at the Health Office

Inspections of the Health Office’s state management activities on pharmaceuticals and cosmetics include the following contents:

1. Annual activity plan development for pharmaceutical work submitted for approval by the competent People's Committee and its implementation;

2. Promotion and dissemination of new regulatory documents on pharmaceuticals and cosmetics;

3. Implementation and coordination with units to enforce regulatory documents and management regulations on pharmaceuticals and cosmetics;

4. Organization and inter-agency coordination in supervising and inspecting the implementation of state management regulations on pharmaceuticals and cosmetics;

5. Coordination with the Department of Health in reviewing and issuing certificates of practice and permits for operating pharmacies according to authority;

6. Statistics and reporting;

7. Administrative reform.

In areas where the People's Committee of districts and counties entrusts health centers with the function of managing health affairs, these contents shall be applied for inspections at those health centers.

Article 5. Contents of inspection at the Drug and Cosmetic Testing Center

1. The work of building plans for inspecting and supervising the quality of drugs and cosmetics within the jurisdiction.

2. The work of organizing and implementing plans to inspect and supervise the quality of drugs and cosmetics within the jurisdiction.

3. Cooperation with competent agencies in the work of inspecting and supervising the quality of drugs and cosmetics within the jurisdiction.

4. Scientific research and application of science and technology.

5. Training of technical staff and scientific research serving drug and cosmetic testing work.

6. Statistical work and report compilation.

Article 6. Contents of inspection at pharmaceutical production facilities

1. Legal entity: Certificate of eligibility for drug business.

2. Implementation of specialized regulations on pharmacy and drug price management.

3. Implementation of Good Practice Principles (GPs).

4. Work of inspecting, controlling, and ensuring drug quality.

5. Organizational and management work of subordinate units (if any): branches, pharmacies, drug counters...

Article 7. Contents of inspection at wholesale drug enterprises, export and import drug businesses

1. Legal entity: Certificate of eligibility for drug business.

2. Implementation of specialized regulations on pharmacy and drug price management.

3. Implementation of regulations on "Good Storage Practices for Drugs - GSP" and "Good Distribution Practices for Drugs - GDP".

4. Work of inspecting, controlling, and ensuring drug quality.

5. Organizational and management work of subordinate units (if any): branches, pharmacies, drug counters...

Article 8. Contents of inspection at retail drug outlets

1. Legal entity: Certificate of eligibility for drug business.

2. Implementation of specialized regulations on pharmacy, outpatient prescription rules, and drug price management regulations.

3. Implementation of regulations on "Good Pharmacy Practice - GPP".

4. Work of inspecting and controlling drug quality.

Article 9. Contents of inspection at drug storage service enterprises

1. Legal entity: Certificate of eligibility for drug business.

2. Implementation of specialized regulations on pharmacy.

3. Implementation of principles of "Good Storage Practices for Drugs - GSP".

Article 10. Contents of inspection at drug testing service enterprises

1. Legal entity: Certificate of eligibility for drug business.

2. Implementation of specialized regulations on pharmacy.

3. Implementation of principles of "Good Laboratory Practices for Drug Testing - GLP".

Article 11. Contents of inspection at cosmetic manufacturing facilities

1. Legal entity: Business registration certificate.

2. Implementation of principles of "ASEAN Good Manufacturing Practices for Cosmetics" (CGMP - ASEAN).

3. Implementation of cosmetic management regulations.

Article 12. Contents of inspection at cosmetic trading enterprises

1. Legal entity: Business registration certificate.

2. Implementation of cosmetic management regulations.

Article 13. Contents of inspection of pharmaceutical work at medical examination and treatment facilities

1. Work of receiving, disseminating, and implementing state management documents on pharmacy, specialized regulations on pharmacy in medical examination and treatment facilities.

2. Activities of the Drug and Treatment Council.

3. Procurement and supply of drugs in hospitals.

4. Management and use of drugs at medical examination and treatment facilities.

5. Clinical pharmacy work, drug information, and adverse drug reaction monitoring (DI&ADR).

6. Implementation of outpatient prescription rules.

7. Compounding of drugs according to prescriptions (if any).

8. Implementation of principles of "Good Storage Practices for Drugs - GSP".

9. Work of inspecting and controlling drug quality.

10. Management of hospital pharmacy activities.

Chapter III

IMPLEMENTATION

Article 14. Implementation Organization

1. The Ministry of Health assigns the Department of Drug Administration responsibility for developing a scoring system to evaluate the implementation of state management regulations on drugs and cosmetics by Provincial Health Departments and guiding Provincial Health Departments to inspect the implementation of state management regulations on drugs and cosmetics every September based on the actual operational situation of the industry.

2. Provincial Health Departments base their guidance for units to self-inspect and evaluate by the end of September each year on the annual guidance from the Department of Drug Administration and the specific characteristics of each locality, adapting to the actual situation of each locality.

Article 15. Inspection Period

1. From October 1 to October 30 each year, subordinate units of the Department of Health, establishments with activities related to pharmaceuticals and cosmetics on the territory shall be responsible for self-inspection and evaluation, scoring relevant aspects of their operations concerning pharmaceutical and cosmetic work based on the guidance of the Department of Health.

2. From November 1 to December 15 each year, the Department of Health shall inspect subordinate establishments and establishments with activities related to pharmaceuticals and cosmetics on the territory within its jurisdiction.

3. In December each year, based on the actual situation of the industry's activities, the Drug Administration will organize focused inspections of some Departments of Health.

Article 16. Summary and Reporting

1. Units conducting self-inspection, evaluation, and summarizing results shall report to the Department of Health before November 5 each year.

2. The Department of Health shall compile, evaluate, classify, and report inspection results to the Drug Administration before December 25 each year according to the Scoring Table for Evaluating the Implementation of State Management Regulations on Pharmaceuticals and Cosmetics by Departments of Health.

Based on the results of implementing state management regulations on pharmaceuticals and cosmetics, the Department of Health shall conclude the annual pharmaceutical and cosmetic work activities and submit the summary report to the Drug Administration before December 25 each year. The format for the summary report on pharmaceutical and cosmetic work is implemented according to Form 1 attached to this Circular.

3. The Drug Administration shall compile, evaluate the results of the inspection of pharmaceutical work of the Departments of Health to report to the Ministry of Health Leadership before January 30 of the following year.

Chapter IV

IMPLEMENTING PROVISIONS

Article 17. Effective Date

1. This Circular takes effect 45 days from the date of issuance. Decree No. 2163/2001/QĐ-BYT dated June 8, 2001 of the Minister of Health regarding the issuance of the "Regulations on the Inspection System for Pharmaceutical Work in Provinces and Cities Directly Under the Central Government" is hereby repealed.

2. The Drug Administration, subordinate units of the Ministry of Health, Departments of Health of provinces and cities directly under the Central Government, and related units shall be responsible for implementing this Circular.

3. During the implementation process, if there are any difficulties, units are requested to promptly reflect them to the Ministry of Health (Drug Administration) for research and appropriate amendments and supplements./.