Thông tư 38/2010/TT-BYT

CIRCULAR

GUIDING FOR INSPECTION OF PERFORMANCE OF STATE MANAGEMENT REGULATIONS ON PHARMACY AND COSMETICS

Pursuant to the Decree No. 188/2007/ND-CP dated 27/12/2007 of the Government regulating functions, tasks, powers and organizational structure of the Ministry of Health;
Pursuant to the Pharmacy Law No. 34/2005 - QH 11 on 14/06/2005;
Pursuant to the Decree No. 79/2006/ND-CP dated 09/08/2006 detailing the implementation of some articles of the Pharmacy Law
Pursuant to the Decree No. 13/2008/NĐ-CP on 04/02/2008 by the Government regulating organization of specialized agencies under People's Committees of centrally-affiliated cities and provinces;
Pursuant to the Decree No. 14/2008/ND-CP dated 04/02/2008 by the Government regulating organization of specialized agencies under People's Committees of districts, towns and cities;
The Ministry of Health guide the examinational activities of the implementation of the state management regulations on pharmaceutical and cosmetic products as follows:

Chapter I

GENERAL REGULATION

Article 1: The scope of regulation and subjects of application

1. Scope of regulation

This Circular guides inspection activities of the implementation of the state management regulations on pharmaceutical and cosmetic products.

2. Objects of application

This Circular applies to agencies, organizations and individuals that have activities related to drugs and cosmetics in Vietnam.

Chapter II

INSPECTION ACTIVITIES

Article 2. Competence of inspection

1. The Ministry of Health shall inspect Departments of Health of the provinces / centrally-affiliated cities.

2. Departments of Health shall inspect units under their administrative authority and units having pharmaceutical and cosmetic products activities in their locality (including units under the Ministry of Health, and units have foreign direct investment capital).

Article 3. Content of inspection at the Department of Health

Examining the state management of pharmaceutical and cosmetic products of the Department of Health includes the following:

1. Operation of making the scheme or plan for development of health profession at their localities and arrangement of the implementation after approval;

2. The direction operation of the implementation of national drug policy;

3. Propagation and dissemination of newly-issued legal documents on pharmaceutical and cosmetic products;

4. The arrangement of implementation and coordination with other units to implement legal documents and regulations on the management of pharmaceutical and cosmetic products;

5. The intersectoral organization and coordination in inspecting and examining the implementation of the state management regulations on pharmaceutical and cosmetic products;

6. The direction activities of the units in increasing use of domestically produced drugs;

7. The direction activities of the units in implementing the principles and standards of good practices (GPs), especially good pharmacy practice (GPP);

8. The professional direction activities of District Departments of Health on the pharmaceutical and cosmetic products in their area;

9. Activities of granting license, receiving and publishing concerning drugs and cosmetics;

10. The direction and inspection of units to implement the provisions on the management of pharmaceutical and cosmetic products in each sector:

a) Management of addictive drugs, psychotropic drugs and precursors;

b) Management of drug quality;

c) Management drug advertising information;

d) Management of drug prices;

e) Management of the pharmaceutical business;

e) Registration of drugs;

g) Bidding and supply of drugs;

h) Management of hospital pharmacy;

i) Drug Information and Adverse Drug Reactions supervision (DI & ADR);

k) Management of cosmetics.

11. Statistical, collective and report activities;

12. The training of pharmaceutical manpower;

13. Administrative reform.

Article 4. Content of inspection at the District Department of Health

Examination of the state management on pharmaceutical and cosmetic products of a district Department of Health includes the following:

1. Activities of making a plan for pharmaceutical operation submitted annually to competent People's Committee for approval and arrange the implement of the plan;

2. Propagation and dissemination of newly-issued legal documents on pharmaceutical and cosmetic products;

3. Arrange the implementation and coordination with other agencies in implementing legal documents and regulations on the management of pharmaceutical and cosmetic products;

4. The intersectoral organization and coordination in inspecting and supervising the implementation of the state management regulations on pharmaceutical and cosmetic products;

5. Coordination with the Department of Health in the evaluation to grant professional practice certificates, certificates of eligibility to drug trading facilities under the competence;

6. Statistical, collective and report activities;

7. Administrative reform.

If at the localities People's Committees of districts assigned a medical center of district to perform state management function for healthcare in the area, the content is applicable to inspection at that Medical Center.

Article 5. Content for inspection at the Center for testing pharmaceutical and cosmetic products

1. Activities for making a plan to inspect and supervise quality of medicines and cosmetics in the area;

2. Arrangement and implementation of the plan to inspect and monitor the quality of medicines and cosmetics in the area;

3. Coordination with other authorities in inspecting, monitoring quality of medicines and cosmetics in the area;

4. Scientific research and technological applications;

5. Training of professional and technical staff and scientific research in service of testing pharmaceutical and cosmetic products;

6. Statistical, collective and report activities.

Article 6. Content to be tested at drug manufacturing facilities

1. Legal entities: the certificate of eligibility for drug trading;

2. Implementation of technical regulations on pharmacy and management of drug prices;

3. Implementation of the principles of good practices (GPs);

4. Inspection, quality control and ensuring drug quality;

5. Organization and management of operation of affiliated units (if any): branches, pharmacies, drug counters...

Article 7. Content for inspection of drug wholesale facilities, exporters and importers of drugs

1. Legal entities: the certificate of eligibility for drug trading;

2. Implementation of technical regulations on pharmacy and management of drug prices;

3. Implementation of regulations on the principle of "Good Storage Practice - GSP" and "Good Distribution Practice - GDP";

4. Inspection, quality control and ensuring drug quality;

5. The organization and management of operation of affiliated units (if any): branches, pharmacies, drug counters...

Article 8. Content for inspection at medicine retail facilities

1. Legal entities: the certificate of eligibility for drug trading;

2. Implementation of technical regulations on pharmacy, drug prescription regulation in outpatient treatment and regulations on management of drug prices;

3. Implementation of regulations on the principle of "good pharmacy practice - GPP";

4. Inspection, control of quality of drugs.

Article 9. Content for inspection at enterprises providing drug storage services

1. Legal entities: the certificate of eligibility for drug trading;

2. Implementation of technical regulations on pharmacy;

3. Implementation of the principles of "Good Storage Practice - GSP".

Article 10. Content for inspection at enterprises that provides drug testing services

1. Legal entities: the certificate of eligibility for drug trading;

2. Implementation of technical regulations on pharmacy;

3. Implementation of the principles of "good laboratory practice - GLP."

Article 11. Content for inspection at cosmetics producing facilities

1. Legal entities: Certificate of business registration;

2. Implementation of the principles of "Cosmetic Good Manufacturing Practices of ASEAN” (CGMP - ASEAN);

3. Implementation of regulations on management of cosmetics.

Article 12. Content for inspection at the cosmetics business facilities

1. Legal entities: Certificate of business registration;

2. Implementation of regulations on management of cosmetics.

Article 13. Content for pharmaceutical operation inspection at diagnosis-treatment facilities

1. The receipt, dissemination and implementation of documents on state management for pharmacy, professional regulations on pharmacy at diagnosis-treatment facilities;

2. Activities of the Council for drug and treatment;

3. Activities of bidding, supplying of drugs in hospitals;

4. The management and use of drugs in healthcare facilities;

5. Clinical pharmacy, drug information and monitoring adverse drug reactions (DI&ADR);

6. Implementation of drug prescription regulations in outpatient treatment;

7. Formulation of drug according to prescription (if any);

8. Implementation of the principles of "Good Storage Practice - GSP";

9. Inspection and control of quality of drugs;

10. Management of the operation of hospital pharmacies.

Chapter III

ORGANIZATION OF IMPLEMENTATION

Article 14. Organization of implementation

1. The Ministry of Health assigned the Drug Administration the obligation to create a score table to inspect and evaluate the implementation of the state management regulations on pharmaceutical and cosmetic products of Provincial Departments of Health and guide the provincial Departments of Health in inspecting the implementation of provisions of state management of pharmaceutical and cosmetic products in September each year based on the actual situation of the sector activities.

2. The Provincial Department of Health shall rely on the annual guidance of the Drug Administration and the characteristics of each locality to guide units in self-inspection and evaluation at the end of September every year in accordance with the actual situation of each locality.

Article 15. Time of inspection

1. From January 10 to October 30 of each year, the units under the Department of Health and facilities engaged in pharmaceutical and cosmetic products in the area are responsible for self-evaluation and score the aspects of the activities related to the pharmaceutical and cosmetic products of their unit based on the Department of Health’s guidelines.

2. From November 1 to December 15 of each year, the Provincial Department of Health shall inspect facilities under their administrative authority and other facilities engaged in pharmaceutical and cosmetic product activities in the area within its competence.

3. In December every year, based on the actual situation of the sector activities, Drug Administration will inspect with a specific focus or main point with respect to a number of Provincial Departments of Health.

Article 16. Summarizing and report

1. Units shall inspect, evaluate and summarize on their own the results and report to the Provincial Department of Health prior to November 5 each year.

2. The Department of Health shall summarize, evaluate, classify and report the result of the inspection to Drug Administration prior to December 25 every year according to the Score Table of inspection and evaluation for the implementation of the state management regulations on pharmaceutical and cosmetic products of the Provincial Departments of Health.

Based on the inspection results of the implementation of the state management regulations on pharmaceutical and cosmetic products, the Provincial Department of Health review the yearly activities in pharmaceutical and cosmetic products and send the final report to Drug Administration prior to December 25 every year. The form of report on summarizing the work of pharmaceutical and cosmetic products are made according to Form 1 attached to this Circular.

3. Drug Administration summarize and evaluate the results of inspection of pharmaceutical activities of Provincial Departments of Health to report to the leaders of the Ministry of Health prior to January 30 of the following year.

Chapter IV

PROVISIONS OF IMPLEMENTATION

Article 17. Effect of implementation

1. This Circular takes effect 45 days from the date of its signing. It annuls the June 08, 2011 Decision No.2163/2001/QD-BYT of the Minister of Health promulgating the Regulation on the regime of inspection of pharmaceutical activities in the provinces and Centrally-affiliated cities.

2. Drug Administration, the units under the Ministry of Health, Department of Health in provinces and centrally-affiliated cities and other relevant units shall implement this Circular.

3. In the course of implementation if any problem arises, the units are required to promptly report to the Ministry of Health (Drug Administration) for studies and amendment accordingly. /.