The Minister of Health issues Decision No. 13/2005/QĐ-BYT to issue the list of vaccines and medical products produced abroad to be considered for registration and circulation in Vietnam in 2005. This decision replaces the previous decision and takes effect fifteen days after its publication in the Official Gazette.
핵심 사항
- The Ministry of Health → issues the list of vaccines and medical products produced abroad to be considered for registration and circulation in Vietnam in 2005.
- The Preventive Medicine Department and HIV/AIDS Prevention and Control Department of the Ministry of Health → notify this Decision to vaccine and medical product manufacturing and trading enterprises.
🌐 이 문서의 사회적 영향
- Positive impact: Ensuring the safety and efficacy of vaccines and medical products used in Vietnam.
- Negative impact: Manufacturing and trading enterprises of vaccines and medical products need to comply with new regulations, which may encounter difficulties in adjusting their operations.
❓ 자주 묻는 질문
When was the list of vaccines and medical products issued?
The list was issued in 2005 pursuant to Decision No. 13/2005/QĐ-BYT.
Which previous decision does this Decision replace?
This Decision replaces Decision No. 387/2004/QĐ-BYT on issuing the list of vaccines and medical products produced abroad to be considered for registration and circulation in Vietnam in 2004.
What should enterprises do when this Decision comes into effect?
Vaccine and medical product manufacturing and trading enterprises need to be notified about this Decision and comply with the new regulations.
When does this Decision take effect?
This Decision takes effect fifteen days after its publication in the Official Gazette.
What responsibility does the Preventive Medicine Department and HIV/AIDS Prevention and Control Department have?
The Preventive Medicine Department and HIV/AIDS Prevention and Control Department of the Ministry of Health are responsible for notifying this Decision to vaccine and medical product manufacturing and trading enterprises.
전문
DECISION OF THE MINISTER OF HEALTH
Regarding the issuance of the list of vaccines and medical products produced abroad
to be considered by the Ministry of Health for registration for circulation in Vietnam in 2005
THE MINISTER OF HEALTH
Pursuant to Decree No. 49/2003/NĐ-CP dated May 15, 2003 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;
Pursuant to Decision No. 4012/2003/QĐ-BYT of the Ministry of Health dated July 30, 2003 promulgating the Vaccine Registration Regulations and Medical Products;
At the proposal of the Director of the Preventive Medicine Department and AIDS Control Department of the Ministry of Health,
DECISION:
Article 1. This Decision hereby approves the List of vaccines and medical products produced abroad to be considered by the Ministry of Health for registration for circulation in Vietnam in 2005 attached hereto.
Article 2. This Decision shall take effect fifteen days from the date of publication in the Official Gazette and shall replace Decision No. 387/2004/QĐ-BYT dated February 12, 2004 on the issuance of the list of vaccines and medical products produced abroad to be considered by the Ministry of Health for registration for circulation in Vietnam in 2004.
Article 3. The Preventive Medicine Department and AIDS Control Department of the Ministry of Health shall be responsible for notifying this Decision to vaccine and medical product manufacturing and trading enterprises.
Article 4. The Heads of the Office, Directors of relevant Departments of the Ministry of Health, Director of the Preventive Medicine Department and AIDS Control Department, Director of the Drug Administration of Vietnam, Heads of subordinate units of the Ministry, Directors of Provincial and Municipal Health Services directly under the Central Government shall be responsible for implementing this Decision./.
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