DECISION No. 3947/2004/QD-BYT OF NOVEMBER 8, 2004 AMENDING AND SUPPLEMENTING THE REGULATION ON REGISTRATION OF VACCINES AND MEDICAL BIO-PRODUCTS
THE MINISTER OF HEALTH
Pursuant to the Government's Decree No. 49/2003/ND-CP of May 15, 2003 prescribing the functions, tasks, powers and organizational structure of the Ministry of Health;
Pursuant to the Health Minister's Decision No. 4012/2003/QD-BYT of July 30, 2003 promulgating the Regulation on registration of vaccines and medical bio-products;
At the proposal of the Director of the Department for Preventive Medicine and HIV/AIDS Prevention and Control,
DECIDES:
Article 1.- To add Clause 3 to Article 5 of the Regulation on registration of vaccines and medical bio-products, issued together with Decision No. 4012/2003/QD-BYT of July 30, 2003, as follows:
3. For vaccines and medical bio-products, which have been granted registration numbers, if there is any change in their selling prices as compared with the dossiers already registered while their registration numbers are still valid, the registering establishments must send reports thereon to the Ministry of Health (the Department for Preventive Medicine and HIV/AIDS Control).
Article 2.- To issue amended Form 3, Form 4 and Form 9 to replace Form 3, Form 4 and Form 9 in the Regulation on registration of vaccines and medical bio-products, issued together with Decision No. 4012/2003/QD-BYT of July 30, 2003.
Article 3.- This Decision takes effect 15 days after its publication in the Official Gazette.
Article 4.- The director of the Office, the Chief Inspector, the director of the Department for Preventive Medicine and HIV/AIDS Prevention and Control, the directors of the Departments under the Ministry of Health, the directors of the provincial/municipal Health Services and organizations and individuals producing and/or trading in vaccines and medical bio-products shall have to implement this Decision.
Minister of Health
TRAN THI TRUNG CHIEN
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Minister |
(Signed) |
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Tran Thi Trung Chien |