Decision No. 3814/QD-BYT of the Ministry of Health amends printing errors in Article 30 of Circular No. 13/2009/TT-BYT, revising clauses regarding deadlines and procedures for information and advertising of medicines.
要点
- If within ten working days from the date recorded on the Receipt Form, the Drug Administration does not issue a letter requesting amendments or supplements, the entity may proceed with information and advertising according to the registered content.
- The Drug Administration shall notify the entity registering information and advertising to supplement and complete the dossier if it is incomplete or invalid within ten working days.
- After ten working days from the date of receipt of the amended and supplemented information and advertising content, if the Drug Administration does not issue a letter requesting amendments or supplements, the entity may proceed with information and advertising according to the amended content.
🌐 本文件的社会影响
- Reduce the burden on enterprises during the registration process for information and advertising of medicines.
- Increase flexibility for entities to adjust and perfect their dossiers.
❓ 常见问题
How long after the date recorded on the Receipt Form can the entity proceed with information and advertising according to the registered content?
Ten working days from the date recorded on the Receipt Form.
If the dossier is incomplete or invalid, how long does the Drug Administration have to notify the entity?
Ten working days.
If the Drug Administration does not issue a letter requesting amendments after receiving the amended and supplemented information and advertising content, how can the entity proceed with information and advertising?
If within ten working days from the date of receipt of the amended and supplemented information and advertising content, the Drug Administration does not issue a letter requesting amendments, the entity may proceed with information and advertising according to the amended content.
When does this Decision take effect?
This Decision takes effect from October 16, 2009.
全文
| MINISTRY OF HEALTH ------- |
SOCIALIST REPUBLIC OF VIET NAM Independence - Freedom - Happiness --------- |
| Number: 3814/QD-BYT | Hanoi, October 9, 2009 |
Pursuant to …;
Regarding the correction of Article 30 of Circular No. 13/2009/TT-BYT dated September 1, 2009 of the Ministry of Health guiding information and advertising activities for medicines
THE MINISTER OF HEALTH
Pursuant to the Law on Legislative Documents No. 17/2008/QH12 dated June 3, 2008;
Pursuant to Decree No. 104/2004/ND-CP dated March 23, 2004 of the Government on the Official Gazette of the Socialist Republic of Vietnam;
Pursuant to Decree No. 188/2007/ND-CP dated December 27, 2007 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;
At the proposal of the Director of the Drug Administration Department;
DECISION:
Article 1. Correcting the printing error in Article 30 of Circular No. 13/2009/TT-BYT dated September 1, 2009 of the Ministry of Health as follows:
In Clause 6, Article 30 shall be amended to read: "Within ten working days from the date recorded on the Receipt, if the Drug Administration does not issue a letter requesting amendments or supplements, the entity has the right to disseminate and advertise according to the registered content."
In Clause 7, Article 30 shall be amended to read: "In case the application for registration of information and advertising for medicines is incomplete or invalid according to this Circular, within ten working days, the Drug Administration shall issue a letter notifying the entity to supplement and complete the application."
In Point b, Clause 8, Article 30 shall be amended to read: "…Within ten working days from the date of receipt of the revised and supplemented information and advertising content, if the Drug Administration does not issue a letter requesting further revisions or supplements, the entity may disseminate and advertise according to the revised content."
Article 2. This Decision takes effect from October 16, 2009. The Heads of the Ministry's Office, the Director of the Drug Administration, and the Heads of related units are responsible for implementing this Decision./.
| DEPUTY MINISTER DEPUTY MINISTER (signed) Cao Minh Quang |
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