Decision No. 22/2005/QĐ-BYT of the Ministry of Health stipulates the templates for vaccine registration permits, medical products registration permits, and company registration permits for vaccine and medical product businesses. This document replaces the previous decision and shall take effect fifteen days from the date of publication in the Official Gazette.
要点
- The Vietnam National Center for Preventive Medicine → issues templates for registration permits for circulating vaccines and medical products produced in Vietnam and imported, as well as templates for operating permits for foreign companies in the field of vaccines and medical products.
🌐 本文件的社会影响
- Positive impact: Helps ensure the quality and safety of vaccines and medical products, enhancing disease prevention effectiveness in the community.
- Negative impact: May cause difficulties for businesses in complying with the new permit templates.
❓ 常见问题
What does the template for a vaccine registration permit and medical product registration permit include?
This decision specifies templates for registration permits for circulating vaccines and medical products produced in Vietnam and imported, as well as templates for operating permits for foreign companies in the field of vaccines and medical products.
When does this decision come into effect?
This decision takes effect fifteen days from the date of publication in the Official Gazette.
Which entities are responsible for implementing this decision?
The Director of the Office, the Inspector General, the Director of the Vietnam National Center for Preventive Medicine, the Heads of Departments under the Ministry of Health; the Director of the Vietnam National Pharmaceutical Administration; the Director of the Vietnam National Food Safety Administration; the Heads of units directly under the Ministry; the Directors of Provincial Health Services; the Directors of Provincial Preventive Medical Centers under central cities and provinces.
Which decision does this decision replace?
Decision No. 5092/2003/QĐ-BYT dated September 30, 2003, on issuing templates for vaccine registration permits, medical products registration permits, and company registration permits for vaccine and medical product businesses.
What must foreign companies do to operate in the field of vaccines and medical products?
Foreign companies must obtain an operating permit according to the template prescribed in Article 1 of this Decision.
全文
DECISION OF THE MINISTER OF HEALTH
Regarding the issuance of sample vaccine registration permits, medical products and sample registration permits for companies operating in the vaccine and medical product business
THE MINISTER OF HEALTH
Pursuant to the Law on Health Protection for the People dated July 11, 1989;
Pursuant to Decree No. 49/2003/NĐ-CP of the Government dated May 15, 2003 stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;
Pursuant to Decision No. 20/2005/QĐ-BYT dated July 26, 2005 of the Minister of Health stipulating the functions, tasks, powers, and organizational structure of the Vietnam Preventive Medicine Department;
At the proposal of the Director of the Vietnam Preventive Medicine Department,
DECISION:
Article 1. Now hereby promulgated together with this Decision:
1. Sample permit for the circulation of vaccines and medical products produced in Vietnam.
2. Sample permit for the circulation of imported vaccines and medical products.
3. Sample permit for the operation of foreign companies in the vaccine and medical product business and raw materials for producing vaccines and medical products in Vietnam.
Article 2. The Standard Measurement Quality Control Department shall be responsible for organizing and guiding the implementation of the Regulations adopted herein.
Repeal Decision No. 5092/2003/QĐ-BYT dated September 30, 2003 regarding the issuance of sample vaccine registration permits, medical products and registration permits for companies operating in the vaccine and medical product business.
Article 3. The Heads of the Office, Inspectorate, Vietnam Preventive Medicine Department, Departments under the Ministry of Health; Director of the Vietnam Drug Administration; Director of the Vietnam Food Safety and Control Department; Heads of units directly under the Ministry; Directors of Provincial Health Departments; Directors of Provincial Preventive Health Centers under central cities are responsible for implementing this Decision.
DEPUTY MINISTER
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