This Decision announces 12 vaccines and medical biological products permitted for circulation in Vietnam, requiring units to print registration numbers on labels and comply with legal regulations. The Decision takes effect from the date of signing.
적용 범위
Vaccine and medical biological product manufacturing and import units; Health Departments of provinces and centrally governed cities; Preventive Medicine Department and related Departments of the Ministry of Health.
핵심 사항
- Announcing 12 vaccines and medical biological products permitted for circulation in Vietnam (Article 1).
- Requiring production and import units to print registration numbers on labels and comply with legal regulations on vaccine and medical biological product production and circulation (Article 2).
- This Decision takes effect from the date of signing (Article 3).
- Heads of units are responsible for implementing this Decision (Article 4).
🌐 이 문서의 사회적 영향
- Positive impact: Ensuring safety and effectiveness in the use of vaccines and medical biological products.
- Negative impact: Increased costs for printing labels may be incurred by production units.
❓ 자주 묻는 질문
What types of vaccines and medical biological products are announced in this Decision?
This Decision announces 12 vaccines and medical biological products including PLATELIAâHTLV-1 NEW, MONOLISAâHBc IgM, Tetanus Antitoxin Serum, Oral Cholera Vaccine, Freeze-Dried BCG Vaccine, etc. (Article 1).
What must production units do when vaccines and medical biological products are announced?
Units must print registration numbers on labels and comply with legal regulations on vaccine and medical biological product production and circulation (Article 2).
When does this Decision take effect?
This Decision takes effect from the date of signing (Article 3).
Who are the units responsible for implementing this Decision?
Heads of units under the Ministry of Health, Directors of Health Departments of provinces and centrally governed cities, and Heads of units with vaccines and immunological biological products permitted for circulation in Vietnam (Article 4).
How many types of vaccines and medical biological products does this Decision apply to?
This Decision announces 12 types of vaccines and medical biological products (Article 1).
전문
DECISION OF THE MINISTER OF HEALTH
Regarding the announcement of 12 vaccines and medical biological productspermitted for circulation in Vietnam Male
_____________________
THE MINISTER OF HEALTH
Pursuant to Decree No. 68/CP dated October 11, 1993 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;
Pursuant to Decision No. 2010/BYT-QÐ dated October 28, 1996 of the Minister of Health promulgating the Regulation on vaccine registration and immunobiological products;
Considering the proposal of the Vaccine Registration Review Board at its meetings on August 22, 2002, and October 29, 2002;
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. Announce 12 vaccines and medical biological products permitted for circulation in Vietnam (as per the attached list).
Article 2. Units with vaccines and medical biological products permitted for circulation in Vietnam must print the circulation registration number issued onto the label and comply strictly with all relevant Vietnamese laws concerning the production and circulation of vaccines and medical biological products.
Article 3. This Decision takes effect from the date of signature and issuance.
Article 4. The following officials are responsible for implementing this Decision: Heads of the Office, Inspectorate, Preventive Medicine Department, Heads of related Departments under the Ministry of Health, Heads of subordinate units under the Ministry, Directors of Health Services of provinces and centrally governed cities, and Heads of units with vaccines and immunobiological products permitted for circulation in Vietnam according to the provisions of Article 1.
LIST OF VACCINES AND MEDICAL BIOLOGICAL PRODUCTS FOR CIRCULATION IN VIETNAM YEAR
(BATCH 12)
(Issued pursuant to Decision No.: 28/2003/QÐ-BYT
dated January 01, 2003 of the Minister of Health)
|
No. |
Name of vaccine, medical biological product |
Manufacturer |
Packaging |
Shelf life |
Registration number |
|
1 |
PLATELIAâHTLV-1 NEW |
Bio-Rad |
Box of 96 tests; Box of 480 tests |
six months |
VNDP-115-1202 |
|
2 |
MONOLISAâHBc IgM |
Bio-Rad |
Box of 96 tests |
six months |
VNDP-116-1202 |
|
3 |
Tetanus Toxin Antitoxin Serum |
Institute of Vaccines and Biological Products |
1500 UI vial, Box of 20 vials |
24 months |
VNDP-117-1202 |
|
4 |
Oral Cholera Vaccine |
Institute of Vaccines and Biological Products |
1.5 ml/dose; Bottle of 5 doses; Box of 10 bottles; Can of 10 liters |
24 months |
VNDP-118-1202 |
|
5 |
Dried BCG Vaccine |
Institute of Vaccines and Biological Products |
0.05 mg/dose; 0.5 mg/vial 1 mg/vial; Box of 20 vials |
30 months |
VNDP-119-1202 |
|
6 |
Biolac |
Company 2 Vaccine and Biological Products |
Tablet 500 mg, strip of 10 tablets, bottle of 100 tablets; Packet of 1 g |
24 months |
VNDP-120-1202 |
|
7 |
Rabivax-II |
Company 2 Vaccine and Biological Products |
0.75 ml/dose, vial of 1 dose, strip of 5 vials, box of 2 strips |
18 months |
VNDP-121-1202 |
|
8 |
IMx HBsAg (V2) |
Abbott GmbH |
Box of 100 tests |
9 months |
VNDP-122-1202 |
|
9 |
AxSYM HCV VERSION 3.0 |
Abbott GmbH |
Box of 100 tests |
9 months |
VNDP-123-1202 |
|
10 |
IMx HCV VERSION 3.0 |
Abbott GmbH |
Box of 100 tests |
9 months |
VNDP-124-1202 |
|
11 |
MUREX HTLV I+II |
Abbott GmbH |
Box of 96 tests; Box of 480 tests |
9 months |
VNDP-125-1202 |
|
12 |
AxSYM HBsAg (V2) |
Abbott GmbH |
Box of 100 tests |
9 months |
VNDP-126-1202 |
DEPUTY MINISTER
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