Decision No. 3947/2004/QD-BYT amends and supplements the Regulation on Vaccine and Medical Product Registration. This decision stipulates the reporting of price changes for vaccines and the format of vaccine and medical product registration forms.
적용 범위
Vaccine and medical product manufacturing and trading establishments
핵심 사항
- Vaccine and medical product registration entities must report to the Ministry of Health if there are price changes different from those in the registered dossier (Article 1)
- Issuing new registration form templates for vaccines and medical products (Form 3, Form 4, Form 9) (Article 2)
🌐 이 문서의 사회적 영향
- Positive impact: Helps to more strictly manage the selling prices of vaccines and medical products
- Negative impact: May increase costs for businesses in complying with regulations
❓ 자주 묻는 질문
What must a vaccine registration entity do when there is a change in selling price?
If the selling price differs from that in the registered dossier, the registration entity must report to the Ministry of Health (Preventive Medicine Department and HIV/AIDS Prevention and Control Department) in writing (Article 1)
What does the new registration form for vaccines and medical products include?
The new form includes information on trade name, manufacturer name, selling price, type of vaccine/medical product, function, indication, dosage, route of administration, stability and storage conditions, expiration date, contraindications, side effects, original strain of vaccine/medical product, packaging style (Form 3, Form 4, Form 9)
When does this decision take effect?
This decision takes effect fifteen days after its publication in the Official Gazette (Article 3)
What should vaccine and medical product manufacturing establishments pay attention to during the registration process?
Manufacturers must provide complete information on trade name, manufacturer name, selling price, type of vaccine/medical product, function, indication, dosage, route of administration, stability and storage conditions, expiration date, contraindications, side effects, original strain of vaccine/medical product, packaging style (Article 2)
When must a vaccine registration entity report?
If there are changes in the selling price of vaccines and medical products different from those in the registered dossier, the registration entity must report to the Ministry of Health (Preventive Medicine Department and HIV/AIDS Prevention and Control Department) in writing (Article 1)
전문
Pursuant to …;
Regarding the amendment and supplementation of the "Regulations on Vaccine and Medical Product Registration"
__________________________________________
THE MINISTER OF HEALTH
Pursuant to Decree No. 49/2003/NĐ-CP dated May 15, 2003 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;
Based on Decision No. 4012/2003/QĐ-BYT dated July 30, 2003, issued by the Minister of Health to promulgate the "Regulations on Vaccine and Medical Product Registration";
At the proposal of the Director of the Preventive Medicine and HIV/AIDS Control Department - Ministry of Health,
DECISION:
Article 1. Supplement Clause 3 to Article 5 of the Vaccine and Medical Product Registration Regulations issued together with Decision No. 4012/2003/QĐ-BYT dated July 30, 2003 as follows:
3. For vaccines and medical products that have been granted registration numbers, during the validity period of such registration numbers, if there is a change in the selling price of the vaccines or medical products different from the information provided in the registration dossier, the registering entity must submit a report in writing to the Ministry of Health (Preventive Medicine Department and HIV/AIDS Prevention and Control Department).
Article 2. Issue revised Model 3, Model 4, and Model 9 to replace Model 3, Model 4, and Model 9 in the Vaccine and Medical Product Registration Regulations issued together with Decision No. 4012/2003/QĐ-BYT dated July 30, 2003 (as attached)
Article 3. This Decision shall take effect fifteen days from the date of publication in the Official Gazette.
Article 4. The Heads of the Office, Inspectorate, Preventive Medicine Department and HIV/AIDS Prevention and Control Department; Heads of Departments and Directorates under the Ministry of Health; Directors of Provincial Health Services; organizations and individuals engaged in vaccine and medical product production and business operations shall be responsible for implementing this Decision./.
ANNEX
MODEL 3
(Issued together with Decision No. 3947/2004/QĐ-BYT dated November 8, 2004
of the Minister of Health)
APPLICATION FOR REGISTRATION
VACCINES AND MEDICAL PRODUCTS FOR PREVENTION AND TREATMENT OF DISEASES
Unit: Equivalent USD: MINISTRY OF HEALTH - PREVENTIVE MEDICINE DEPARTMENT AND HIV/AIDS PREVENTION AND CONTROL DEPARTMENT
138A Giang Vo Street - Hanoi
1. Trade name: Common name:
2. Name of manufacturing entity:
- Director of the manufacturing entity:
- Address:
- Telephone: Fax:
3. Price:
- CIF Price:
- FOB Price:
- Selling Price in Vietnam:
4. Form of vaccine, medical product:
5. Unit of measurement:
6. Function:
7. Indication and dosage:
8. Route of administration:
9. Stability and storage conditions:
10. Expiry date:
11. Contraindications and side effects:
12. Strain used for vaccine production:
13. Packaging type:
|
Director of the manufacturing entity (Signature and seal) |
Hanoi, day month year 200 Director of the registering entity (Signature and seal) |
ANNEX
MODEL 4
(Issued together with Decision No. 3947/2004/QĐ-BYT dated November 8, 2004 of the Minister of Health)
APPLICATION FOR REGISTRATION OF DIAGNOSTIC MEDICAL PRODUCTS
Unit: Equivalent USD: MINISTRY OF HEALTH - PREVENTIVE MEDICINE DEPARTMENT AND HIV/AIDS PREVENTION AND CONTROL DEPARTMENT
138A Giang Vo Street - Hanoi
1. Trade name: Common name:
2. Name of manufacturing entity:
- Director of the manufacturing entity:
- Address:
- Telephone: Fax:
3. Price:
- CIF Price:
- FOB Price:
- Selling Price in Vietnam:
4. Form of diagnostic medical product:
5. Unit of measurement:
6. Function:
7. Indication and dosage:
8. Method of use:
9. Stability and storage conditions:
10. Expiry date:
11. Packaging type:
|
Director of the manufacturing entity (Signature and seal) |
Hanoi, day month year 200 Director of the registering entity (Signature and seal) |
ANNEX
MODEL 9
(Issued together with Decision No. 3947/2004/QĐ-BYT dated November 8, 2004 of the Minister of Health)
APPLICATION FOR REISSUANCE OF REGISTRATION NUMBER FOR VACCINES AND MEDICAL PRODUCTS
Unit: Equivalent USD: MINISTRY OF HEALTH - PREVENTIVE MEDICINE DEPARTMENT AND HIV/AIDS PREVENTION AND CONTROL DEPARTMENT
138A Giang Vo Street - Hanoi
1. Trade name: Common name:
2. Name of manufacturing entity:
- Director of the manufacturing entity:
- Address:
- Telephone: Fax:
3. Price:
- CIF Price:
- FOB Price:
- Selling Price in Vietnam:
4. Form of vaccine, medical product:
5. Quantity, unit:
6. Function:
7. Indication and dosage:
8. Route of administration:
9. Stability and storage conditions:
10. Expiry date:
11. Contraindications and side effects:
12. Strain of vaccine, medical product:
13. Packaging type:
14. Previously issued registration number and issuance date:
|
Director of the manufacturing entity (Signature and seal) |
Hanoi, day month year 200 Director of the registering entity (Signature and seal) |
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