The Decision 3947/2004/qd-Byt: Modification, Additional "registration Of Vaccines, Medical Products"

Original Language Title: Quyết định 3947/2004/QĐ-BYT: Về việc sửa đổi, bổ sung "Qui chế đăng ký vắc xin, sinh phẩm y tế"

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A decision on the amendment and supplement "to register vaccines, medical products" _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ MINISTER of health pursuant to Decree No. 49/2003/ND-CP on 15/5/2003 by government mandate the functions, duties, powers and organizational structure of the Ministry of health;
Pursuant to decision No. 4012/2003/QD-BYT on 30/7/2003 by the Minister of health on issuing "registered medical products, vaccine";
At the suggestion of the Director of preventive medicine and HIV/AIDS-health, decision: article 1. Supplement paragraph 3 to article 5 of the regulations to register vaccines, medical products attached to decision No 3922/2003/QD-BYT on 30/7/2003 are as follows: 3. The vaccines, medical products have been given the registration number, in the time of registration is valid, if changing the sale price of vaccines other medical products, with registered records the registered facility must have a written report the Ministry of health (the Department of preventive medicine and HIV/AIDS).
Article 2. Released model 3, model 4, model 3 modified to replace the model 3, model 4, model 9 registration regulations in vaccine, medical products attached to decision No 3922/2003/QD-BYT on 30/7/2003 (according to the attached appendix) article 3. This decision takes effect 15 days from the date the report.
Article 4. The He, she: Chief, Chief Inspector, Chief of preventive medicine and HIV/AIDS; Bureau Chief, Director of the Bureau, under the Ministry of Health Services; The Director of the Health Department of the province, central cities, organizations, individuals, business and manufacturing vaccines, medical products is responsible for the implementation of this decision.
 
APPENDIX 3-FORM (attached to decision No. 3947/2004/QD-BYT on 08 November 2004 of the Minister of health) REGISTERED vaccines, BIOLOGICAL PREVENTION, healing dear: Department of health-BUREAU of health and HIV/AIDS 138A Giang Vo, Hanoi 1. Commercial name: Common Name: 2. name the production base: production Director:-address:-phone: Fax: 3. Price: FOB Price:-CIF-price: selling price in Vietnam: 4. The form of the vaccine, born: 5. Unit: 6. Use: 7. Specify, dosage: 8. Roads: 9. Stability and preserving : 10. Expiration: 11. Contraindications, side effects,: 12. The original strains used to produce vaccines, born: 13. Package: Director production facilities (signed and stamped) Hanoi, may day 200 campus sign (signed and stamped) APPENDIX 4 FORM (attached to decision No. 3947/2004/QD-BYT on 08 November 2004 of the Minister of health) REGISTERED DIAGNOSTIC PRODUCTS dear : Department Of Health-BUREAU Of Health And HIV/AIDS 138A Giang Vo, Hanoi 1. Commercial name: Common Name: 2. name the production base: production Director:-address:-phone: Fax: 3. Price: FOB Price:-CIF-price: selling price in Vietnam: 4. The form of birth: 5. Unit: 6. Use: 7. Specify, dosage: 8. Usage: 9. Stability and preservation conditions : 10. Expiration: 11. Package: Director production facilities (signed and stamped) Hanoi, may day 200 campus sign (signed and stamped) TEMPLATE APPENDIX 9 (attached to decision No. 3947/2004/QD-BYT on 2004-11-08tháng of the Minister of health) APPLICATION NUMBER VĂC PLEASE PRODUCTS, dear: health-DEPARTMENT of preventive medicine and HIV/AIDS 138A Giang Vo, Hanoi 1. Commercial name: Common Name: 2. name the production base: production Director:-address:-phone: Fax: 3. Price: FOB Price:-CIF-price: selling price in Vietnam: 4. The form of the vaccine, born: 5. number of units: 6. Use: 7. Specify, dosage: 8. Roads: 9. Stability and preservation conditions : 10. Expiration: 11. Contraindications, side effects,: 12. The original vaccine strains, born: 13. Package: 14. The registration number and date of issue issued: Director production facilities (signed and stamped) Hanoi, may day 200 campus sign (signed and stamped)