Decision No. 151/2007/QĐ-TTg issues regulations on importing medicines without registration numbers in Vietnam, applicable to enterprises and health management agencies. Notably, it details import procedures and responsibilities of relevant parties.
적용 범위
Enterprises importing medicines, the Ministry of Health, related ministries, sectors, and localities.
핵심 사항
- Enterprises importing medicines without registration numbers in Vietnam → must comply with the import documentation and procedures stipulated in this Decision.
- The Ministry of Health → is responsible for guiding, supervising the implementation of these regulations.
🌐 이 문서의 사회적 영향
- Positive impact: Enhance the quality of medicine management and safety in the Vietnamese market.
- Negative impact: May cause difficulties for enterprises in importing medicines if they fail to comply with the regulations.
❓ 자주 묻는 질문
What documents do enterprises need to prepare when importing medicines without registration numbers?
According to this Decision, enterprises must prepare documents including proof of origin of the medicines; test results of the quality of the medicines; and other documents as prescribed.
What is the effective duration of this Decision?
This Decision takes effect fifteen days from the date of publication in the Official Gazette.
What responsibilities does the Ministry of Health have in implementing this Decision?
The Ministry of Health is responsible for guiding, supervising, and inspecting the implementation of regulations on importing medicines without registration numbers in Vietnam.
Which previous regulations does this Decision replace?
Previous regulations conflicting with this Decision are abolished.
Do enterprises need to comply with this regulation when importing medicines from abroad?
Yes, enterprises importing medicines without registration numbers in Vietnam must comply with the stipulated documentation and procedures under this Decision.
전문
Pursuant to …;
Issuing Regulations on Importing Medicines Not Yet Registered in Vietnam
__________________________
PRIME MINISTER
Pursuant to the Law on Organization of the Government dated December 25, 2001;
Pursuant to the Drug Law dated June 14, 2005;
Pursuant to the Law on Prevention and Control of Narcotics dated December 22, 2000;
Considering the proposal of the Minister of Health,
DECISION:
Article 1. These Regulations on Importing Medicines Not Yet Registered in Vietnam are hereby promulgated together with this Decision.
Article 2. This Decision shall take effect fifteen days after its publication in the Official Gazette. Any previous provisions contrary to this Decision are abolished.
Article 3. The Minister of Health shall be responsible for guiding and implementing this Decision.
THE MINISTERS, HEADS OF GOVERNMENT-LEVEL MINISTRIES, HEADS OF GOVERNMENT-LEVEL AGENCIES, AND CHAIRMEN OF PROVINCE AND CITY PEOPLE'S COMMITTEES DIRECTLY UNDER THE CENTRAL GOVERNMENT SHALL BE RESPONSIBLE FOR ENFORCING THIS DECISION./.
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