| THE MINISTRY OF HEALTH |
|
| No: 4198/1999/QD-BYT | |
DECISION
PROMULGATING THE LIST OF FOREIGN-MADE VACCINES AND IMMUNE BIO-PRODUCTS TO BE CONSIDERED BY THE MINISTRY OF HEALTH FOR GRANTING OF REGISTRATION NUMBERS FOR CIRCULATION IN
THE MINISTER OF HEALTH
Pursuant to the Governments Decree No. 68/CP of October 11, 1993 stipulating the functions, tasks, powers and organizational structure of the Ministry of Health;
Pursuant to the June 30, 1989 Law on Protection of Peoples Health;
Pursuant to the Ministry of Healths Decision No. 2010/QD-BYT of October 28, 1996 promulgating the Regulation on registration of vaccines and immune bio-products;
At the proposal of the Council for consideration and approval of the registration of vaccines and immune bio-products, at its September 23, 1998 meeting;
At the proposal of the director of the Department of Prophylactic Medicine under the Ministry of Health,
DECIDES:
Article 1.- To promulgate together with this Decision the list of foreign-made vaccines and immune bio-products to be considered by the Ministry of Health for granting of registration numbers for circulation in
Article 2.- Foreign-made vaccines and immune bio-products already granted registration numbers for circulation in
Article 3.- This Decision takes effect as from January 1st, 2000 and replaces Decision No. 3255/1998/QD-BYT of November 21, 1998.
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Article 5.- The director of the Ministrys Office, the director of the Department of Prophylactic Medicine and directors of the concerned departments of the Ministry of Health, the director of the Vietnam Pharmaceutical Management Department, the heads of the units attached to the Ministry, and the directors of the Health Services of the provinces and centrally-run cities shall have to implement this Decision.
MINISTER OF HEALTH
Do Nguyen Phuong
THE LIST
OF FOREIGN-MADE VACCINES AND IMMUNE BIO-PRODUCTS TO BE CONSIDERED BY THE MINISTRY OF HEALTH FOR GRANTING OF REGISTRATION NUMBERS FOR CIRCULATION IN VIETNAM IN 2000
(Promulgated together with the Health Ministers Decision No.4198/1999/QD-BYT of December 29, 1999)
Ordinal number
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Commodity names
Registration basis
Heading
Subheading
I
1
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3
4
5
6
7
8
9
10
11
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13
14
15
II
1
2
3
4
5
...
...
...
8
III
2
5
6
VI
3002
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3002
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3002
20
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90
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90
90
-
-
10
50
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-
-
-
-
-
20
90
30
90
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90
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90
Vaccines for
- Recombinant hepatitis
- Japanese encephalitis
- Meningococcal meningitis
- Cell rabies
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- Parotiditis
- Rubeola
- Varicella
- Influenza
- Typhoid
- Haemophilus influenza, of type b
- Diphtheria
- Whooping cough
- Tetanus
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Therapeutic bio-products
- Anti-hydrophobic serum
- Anti-venin serum
- Anti-diphtheritic toxin serum
- Anti-tetanic toxin serum
- Assorted immunogenic globulins
- Assorted cytokines (interferon, interleukine)
- Anti-hypersensitive antigens
- Anti-toxin serum
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- Bio-products for diagnosis of human virus infection
- Bio-products for diagnosis of human bacteria infection
- Bio-products for diagnosis of human parasite infection
- Bio-products for pregnancy diagnosis
- Bio-products for diagnosis of blood groups and a number of blood products
- Bio-products for diagnosis of immune cells (fluorescent antibodies T4, T8...)
Environments for microbial culture
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* According to standards recognized by the Ministry of Health
Decision No. 4198/1999/QD-BYT of December 29, 1999, promulgating the list of foreign-made vaccines and immune bio-products to be considered by the Ministry of Health for granting of registration numbers for circulation in Vietnam in 2000
- Số hiệu: 4198/1999/QD-BYT
- Loại văn bản: Quyết định
- Ngày ban hành: 29/12/1999
- Nơi ban hành: Bộ Y tế
- Người ký: Đỗ Nguyên Phương
- Ngày công báo: Đang cập nhật
- Số công báo: Đang cập nhật
- Ngày hiệu lực: 01/01/2000
- Tình trạng hiệu lực: Chưa xác định