Decision No. 04/2006/QD-BYT issues the Supplement to the Vietnamese Pharmacopoeia, Third Edition, including national standards for new raw materials and formulations as well as amendments and supplements to 195 monographs. The Decision takes effect from April 1, 2006.
적용 범위
Vietnam National Drug Administration, Department of Science and Training, Chairman of the Vietnamese Pharmacopoeia Council, Director of the Ministry of Health's Office, General Director of Vietnam Pharmaceutical Joint Stock Corporation, Directors of Health Departments of provinces and centrally administered cities, and related units within the Ministry of Health.
핵심 사항
- The Supplement to the Vietnamese Pharmacopoeia, Third Edition includes 22 monographs on new raw materials and formulations, replacing outdated monographs;
- There are 163 monographs on drugs and 32 monographs on testing methods that have been amended or supplemented;
- The Decision takes effect from April 1, 2006, abolishing previous regulations inconsistent with the Supplement to the Vietnamese Pharmacopoeia, Third Edition;
- The Vietnam National Drug Administration and related units are responsible for guiding the implementation of the Supplement to the Vietnamese Pharmacopoeia;
🌐 이 문서의 사회적 영향
- Positive impact: Improving drug management quality, ensuring safety for drug users;
- Negative impact: May cause difficulties in transitioning from old to new regulations for some entities;
- Limiting the rights of healthcare facilities and pharmaceutical enterprises to comply with new standards;
❓ 자주 묻는 질문
What does the Supplement to the Vietnamese Pharmacopoeia, Third Edition include?
The Supplement to the Vietnamese Pharmacopoeia, Third Edition includes 22 monographs on new raw materials and formulations, along with 163 monographs on drugs and 32 monographs on testing methods that have been amended or supplemented;
When does this Decision take effect?
The Decision takes effect from April 1, 2006;
Which agencies are responsible for implementing the Supplement to the Vietnamese Pharmacopoeia, Third Edition?
The Vietnam National Drug Administration, Department of Science and Training, and Chairman of the Vietnamese Pharmacopoeia Council are responsible for guiding the implementation of the Supplement to the Vietnamese Pharmacopoeia, Third Edition;
When are the old regulations abolished?
Previous regulations inconsistent with the Supplement to the Vietnamese Pharmacopoeia, Third Edition were abolished from April 1, 2006;
Which agencies are responsible for enforcing this Decision?
The Director of the Ministry of Health's Office, Head of the Department of Science and Training, Director of the Vietnam National Drug Administration, and related departments and bureaus within the Ministry of Health, General Director of Vietnam Pharmaceutical Joint Stock Corporation, Directors of Health Departments of provinces and centrally administered cities, Directors of Health Departments under Ministries and Sectors, and the Chairman of the Vietnamese Pharmacopoeia Council are responsible for enforcing this Decision.
전문
Pursuant to …;
Regarding the issuance of the Supplement to the Vietnamese Pharmacopoeia, Third Edition
_____________________________________
THE MINISTER OF HEALTH
Pursuant to the Law on People's Health Protection 1989;
Pursuant to the Regulation on Standardization Work issued together with Decree No. 141-HĐBT dated August 24, 1982 of the Council of Ministers;
Pursuant to Decision No. 85-HĐBT dated August 1, 1983 of the Council of Ministers concerning the delegation to the Heads of certain leading sectors to review and issue TCVN;
Pursuant to the Government's Decree No. 49/2003/NĐ-CP dated May 15, 2003 stipulating the functions, powers, and organization of the Ministry of Health;
Considering the Circular of the Pharmacopoeia Council No. 68/DĐ-DT dated September 5, 2005 requesting a decision to issue the Supplement to the Vietnamese Pharmacopoeia, Third Edition;
At the proposal of the Director of the Vietnam Drug Administration Bureau,
DECISION:
Article 1. Issuing the Supplement to the Vietnamese Pharmacopoeia, Third Edition, including National Standards:
1. 22 new monographs on raw materials and dosage forms added to the Pharmacopoeia or replacing monographs in the Vietnamese Pharmacopoeia, Third Edition that are no longer appropriate;
2. Amendments or supplements related to 195 monographs in the Vietnamese Pharmacopoeia, Third Edition: including 163 monographs on drugs and 32 monographs on testing methods.
Article 2. This Decision shall take effect fifteen days from the date of publication in the Official Gazette. The National Standards listed in the Supplement to the Vietnamese Pharmacopoeia, Third Edition shall be officially issued and applied from April 1, 2006. All previous regulations contrary to those in the Supplement to the Vietnamese Pharmacopoeia, Third Edition are hereby abolished./.
Article 3. The Directors of the Vietnam Drug Administration Bureau, the Heads of the Science and Training Department, and the Chairman of the Vietnamese Pharmacopoeia Council are responsible for guiding the implementation of the Supplement to the Vietnamese Pharmacopoeia, Third Edition.
Article 4. The Heads of the Office of the Ministry of Health, the Heads of the Science and Training Department, the Director of the Vietnam Drug Administration Bureau, and the Heads of relevant Departments and Bureaus within the Ministry of Health, the General Directors of the Vietnam Pharmaceutical Corporation, the Directors of Provincial Health Services under central cities and provinces, the Directors of Health Services under Ministries and Sectors, and the Chairman of the Vietnamese Pharmacopoeia Council are responsible for enforcing this Decision./.
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