This Decision issues the list of vaccines and medical products produced abroad to be considered for registration and circulation in Vietnam in 2003. The list includes various types of vaccines such as hepatitis, measles, mumps, chickenpox... and diagnostic and treatment medical products.
要点
- Ministry of Health → issues the list of vaccines and medical products produced abroad to be considered for registration and circulation in Vietnam in 2003
- Enterprises producing and trading in vaccines and medical products → need to monitor this list to know the types of vaccines and medical products that can be imported and circulated in Vietnam
- Departments of Health of provinces and centrally governed cities → are responsible for implementing this Decision
- Department of Preventive Medicine - Ministry of Health → notify this Decision to enterprises producing and trading in vaccines and medical products
- This Decision takes effect from January 1, 2003 and replaces Decision No. 339/2002/QÐ-BYT
🌐 本文件的社会影响
- Enterprises producing and trading in vaccines and medical products will have specific guidance on the types of vaccines and medical products permitted to circulate in Vietnam
- Citizens will have more choices regarding high-quality vaccines and medical products from abroad
❓ 常见问题
To which year does this list apply?
This list applies to the year 2003.
What should enterprises do when they know about this list?
Enterprises producing and trading in vaccines and medical products need to monitor the list to know the types of vaccines and medical products that can be imported and circulated in Vietnam.
Which decision does this decision replace?
This Decision replaces Decision No. 339/2002/QÐ-BYT dated February 5, 2002 on the issuance of the list of vaccines and medical products produced abroad to be considered for registration and circulation in Vietnam in 2002.
What types of vaccines are mentioned in the list?
The list includes vaccines such as recombinant hepatitis, Japanese encephalitis, meningococcal meningitis, rabies cell, measles, mumps, rubella, chickenpox, influenza, typhoid, Haemophilus influenzae type b, dengue fever, diphtheria, pertussis, tetanus.
What types of medical products are mentioned in the list?
The list includes medical products such as anti-rabies, antivenom, antitoxin diphtheria, antitoxin tetanus, immunoglobulin, cytokine (interferon, interleukin), allergen extract, antitoxin botulinum toxin serum.
全文
DECISION OF THE MINISTER OF HEALTH
Regarding the issuance of the list of vaccines and medical biological products produced abroad
that the Ministry of Health considers for registration for circulation in Vietnam Pursuant to the Law on Protecting the People's Health dated Male Year 2003
_________________________________
THE MINISTER OF HEALTH
Pursuant to the Government's Decree stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health; 30/6/1989
Pursuant to Decree No. 68/CP dated 11/10/1993 Pursuant to Decision No. 2010/QD-BYT of the Minister of Health dated
promulgating the Vaccine Registration Regulations; 28/10/1996 At the proposal of the Director of the Preventive Medicine Department - Ministry of Health,
This Decision hereby issues the List of vaccines and medical biological products produced abroad that the Ministry of Health considers for registration for circulation in Vietnam in 2003.
DECISION:
Article 1. This Decision takes effect from the date and replaces
Article 2. Decision No. 339/2002/QD-BYT dated February 5, 2002 regarding the issuance of the list of vaccines and medical biological products produced abroad that the Ministry of Health considers for registration for circulation in Vietnam in 2002 01/01/2003 The Preventive Medicine Department - Ministry of Health shall be responsible for notifying this Decision to vaccine and medical biological product manufacturing and trading enterprises.
Article 3. You, Mr./Ms.: Chief of Office, Director of the Preventive Medicine Department and Directors of relevant Departments of the Ministry of Health, Director of the Drug Administration of Vietnam, Heads of units under the Ministry, Directors of Provincial Health Services shall be responsible for implementing this Decision.
Article 4. List of Vaccines and Medical Biological Products Produced Abroad That the Ministry of Health
Considers for Registration for Circulation in Vietnam 826/2003/QD-BYT
December 13 Male Year 2003
(Attached to Decision No.: Product Code
- Recombinant Hepatitis the 3 I. Position and Function.
|
No. |
- Japanese Encephalitis |
Product Name |
On the basis of |
||
|
|
Group |
Subgroup |
|
registration |
|
|
I |
3002 |
20 |
|
Vaccine |
the Director |
|
1 |
|
|
90 |
- Meningococcal Meningitis |
Technical requirements |
|
2 |
|
|
- |
- Rabies Cell Culture |
chuẩn |
|
3 |
|
|
- |
- Measles |
amended and supplemented by Law No. 87/2025/QH15; |
|
4 |
|
|
10 |
- Mumps |
Ministry of Health |
|
5 |
|
|
50 |
- Rubella |
person |
|
6 |
|
|
90 |
- Varicella |
received |
|
7 |
|
|
- |
- Influenza |
|
|
8 |
|
|
- |
- Typhoid |
|
|
9 |
|
|
- |
- Haemophilus influenzae type b |
|
|
10 |
|
|
- |
- Dengue Fever |
|
|
11 |
|
|
- |
- Diphtheria |
|
|
12 |
|
|
- |
- Pertussis |
|
|
13 |
|
|
20 |
- Tetanus |
|
|
14 |
|
|
90 |
- Pneumococcus |
|
|
15 16 17 |
|
|
30 90 - |
- Oral Polio Vaccine Therapeutic Biological Products - Rabies Antiserum |
|
|
II |
3002 |
10 |
|
- Snake Venom Antiserum |
the Director |
|
1 |
|
|
|
- Diphtheria Toxoid Antiserum |
Technical requirements |
|
2 |
|
|
|
- Tetanus Toxoid Antiserum |
chuẩn |
|
3 |
|
|
|
- Various Immunoglobulins |
amended and supplemented by Law No. 87/2025/QH15; |
|
4 |
|
|
|
- Various Cytokines (Interferon, Interleukin) |
Ministry of Health |
|
5 |
|
|
|
- Various Allergens |
person |
|
6 |
|
|
|
- Botulinum Toxin Antiserum |
received |
|
7 |
|
|
|
- Blood Products |
|
|
8 9 |
|
|
|
Diagnostic Biological Products - Human Viral Diagnostic Biological Products |
|
|
III |
3002 |
90 |
90 |
- Human Bacterial Diagnostic Biological Products |
the Director |
|
1 |
|
|
|
- Human Parasitic Diagnostic Biological Products |
which will be mandatory standards to be applied throughout all subsequent stages of the project including surveying, designing, design document acceptance, construction, quality control and supervision, completion acceptance, and management, maintenance, and operation of the works. |
|
2 |
|
|
|
- Pregnancy Diagnostic Biological Products |
amended and supplemented by Law No. 87/2025/QH15; Ministry of Health |
|
3 |
|
|
|
- Blood Grouping Diagnostic Biological Products |
Recognizing |
|
4 5
6 |
|
|
|
- Immunoassay Diagnostic Biological Products (fluorescent antibody T4, T8...) Semi-finished products of various vaccines and biological products listed in Sections I, II, III meeting standards recognized |
|
|
IV |
3002 |
|
|
by the Ministry of Health |
the Director meets the standard recognized by the Ministry of Health |
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