Decision No. 06/2006/QD-BYT of the Ministry of Health cancels the list of active substances and dosage forms not accepting new registration and re-registration applications for foreign drugs issued previously. The Decision takes effect fifteen days after its publication in the Official Gazette.
要点
- The Ministry of Health cancels the list of active substances and dosage forms not accepting new registration and re-registration applications for foreign drugs issued previously.
- The Decision takes effect fifteen days after its publication in the Official Gazette.
- Relevant agencies such as the Director of the Ministry of Health's Office, the Director General of the Vietnam Drug Administration, Heads of Departments under the Ministry of Health, the Inspector General, Heads of subordinate units of the Ministry of Health, Directors of Provincial Health Services, Heads of Health Departments of centrally governed cities, Heads of health sectors, and Heads of related units are responsible for implementing this Decision.
- The Decision does not specify the rights or obligations of any individual or organization.
- The Decision does not provide specific penalties or sanctions.
🌐 本文件的社会影响
- Positive impact: Reduces administrative burden for enterprises importing foreign drugs, increases convenience in drug registration and management.
- Negative impact: May cause difficulties for health authorities in controlling drug quality.
❓ 常见问题
When does the Decision take effect?
The Decision takes effect fifteen days after its publication in the Official Gazette.
Which active substances and dosage forms are cancelled?
Active substances and dosage forms not accepting new registration and re-registration applications for foreign drugs issued previously.
How does this Decision affect enterprises importing foreign drugs?
The Decision reduces the administrative burden for enterprises importing foreign drugs, facilitating drug registration and management.
全文
Pursuant to …;
Regarding the cancellation of the list of active substances and dosage forms not accepting new registration applications and re-registration applications for foreign drugs
________________________________
THE MINISTER OF HEALTH
Pursuant to the Medicine Law on June 14, 2005;
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;
At the proposal of the Director of the Vietnam Drug Administration Bureau,
DECISION:
Article 1. Cancel the list of active substances and dosage forms not accepting new registration applications and re-registration applications for foreign drugs issued together with Decision No. 4819/2004/QĐ-BYT dated December 30, 2004 of the Minister of Health.
Article 2. This Decision shall take effect fifteen days from the date of publication in the Official Gazette.
Article 3. The Heads of the Office, Director of the Vietnam Drug Administration Bureau, Heads of Departments under the Ministry of Health, Inspector General, Heads of units directly under the Ministry of Health, Directors of Provincial Health Services, Central City Health Services, Health Sector Heads, and Heads of related units are responsible for implementing this Decision./.
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