| THE MINISTRY OF PUBLIC HEALTH ------------- | SOCIALIST REPUBLIC OF VIET NAM Independence - Freedom – Happiness -------------- |
| No. 3886/2004/QD-BYT | Hanoi, November 3, 2004 |
DECISION
ON APPLICATION OF THE WORLD HEALTH ORGANIZATION'S "GOOD MANUFACTURING PRACTICES" PRINCIPLES AND STANDARDS
THE MINISTER OF HEALTH
Pursuant to the July 11, 1989 Law on Protection of the People's Health;
Pursuant to the December 24, 1999 Ordinance on Goods Quality;
Pursuant to the Government's Decree No. 49/2003/ND-CP of May 15, 2003 defining the functions, tasks, powers and organizational structure of the Ministry of Health;
Pursuant to the Prime Minister's Decision No. 108/2002/QD-TTg of August 15, 2002 approving the pharmaceutical development strategy till 2010;
At the proposal of the director of Vietnam Pharmacy Management Department,
DECIDES:
Article 1.- To organize the application of the World Health Organization (WHO)'s "Good Manufacturing Practices" principles and standards at Vietnam-based medicine-manufacturing establishments.
Article 2.- To promulgate together with this Decision the guidance for application of the WHO’s "Good Manufacturing Practices".
Article 3.- This Decision takes effect 15 days after its publication in the Official Gazette.
Article 4.- The director of Vietnam Pharmacy Management Department shall have to organize the application of the WHO's "Good Manufacturing Practices" principles and standards.
Article 5.- The director of the Office and the chief inspector of the Health Ministry, the director of Vietnam Pharmacy Management Department, the heads of the units, of the Ministry, the directors of the provincial/municipal Health Services, and the branch medical establishments shall have to implement this Decision.
| | HEALTH MINISTER Tran Thi Trung Chien |
GUIDANCE
ON APPLICATION OF THE WHO'S "GOOD MANUFACTURING PRACTICES"
(Promulgated together with the Health Minister's Decision No. 3886/2004/QD-BYT of November 3, 2004)
I. GENERAL PROVISIONS
1. Purposes:
On September 9, 1996, the Health Minister signed Decision No. 1516/BYT-QD on the application of "Good Manufacturing Practices" principles and standards of the Association of Southeast Asian Nations (GMP-ASEAN) at all western medicine-producing establishments. After 8 years' application, many medicine-producing establishments have satisfied the GMP-ASEAN standards. Vietnam's pharmaceutical industry has seen clear improvements, the enterprises satisfying GMP-ASEAN standards have manufactured quality medicines for users and export, the basic targets of Vietnam's national medicine policy have been attained. GMP-ASEAN principles and standards are substantially based on WHO's recommendations, however, for integration into the global economy, compatibility with international standards on GMP and promotion of the export and cooperation with other countries in the world, the Health Minister hereby decides on the application of WHO's "Good Manufacturing Practices" principles and standard (GMP-WHO).
