Ministry of Health Socialist Republic of Viet Nam
Vietnamese Department of Drug Independence-Freedom -Happiness
and Administration
No: 90/ 2004/QD-QLD
Hanoi, July 27,2004
Decision by the Head of
Vietnamese Department of Drug and Administration
Declaration of permiss for home made drug 's circulation in Vietnam
Head of Vietnamese Department of Drug and Administration
- Based on the law of health care protection dated July 11, 1989.
- Based on the Ordinance of disease treating and preventing drug, accompanied with the Decree No 23/HDBT dated January 24, 1991 by the Ministerial Council ( presently the Government) of Socialist Republic of Viet Nam
- Based on the Decree No 49/2003/ND-CP dated May 15, 2003 by the Government, stipulating function, responsibility, power and structure of the Ministry of Health
- Based on the Decision No 547/TTg dated August 13, 1996 by the Prime Minister stipulating the establishment of Vietnamese Department of Drug and Administration
- Based on the Decision N3121/2001/QD-BYT dated July 18,2001 by the Minister of Health stipulating the application procedure for drug circulation.
- Considering the proposal dated June 30,2004 by the Drug Review Council.
Decide
Article 1: Declaration of permiss for home made drug 's circulation in Vietnam
Applicant unit: Materia Medica Institute of Research and Application for Incurable diseases
Head quarter: 18 Nguyen Chi Thanh Str - Lang Thuong - Dong Da - Hanoi
Manufacturer: Que lam pharmaceutical Company Limited.
Place of manufacturing: 17th Km, Nhu Quynh Industrial Zone - Van Lam - Hung Yen Province.
|
Item |
Name of drug composition |
Package |
Standardization |
Validity |
Re. No. |
|
01 |
Cedemex (Radix Codonopsis pilosulae, Cortex Eucommiae, Rhizoma Coptidis, Radix Achyranthis bidentatae, Radix Rehmanniae glutinosae, Rhizoma Atractylodis macrocepthalae…) |
Box18 Blisters x 10 capsules |
Manufacturing Specifications |
24 months |
NC03- H07-05 |
Article 2: The manufacturer shall print the Re.No. in the Article 1 on the drug's label and follow strictly the regulations related to pharmaceutical production and circulation. The Re. No. is effected for one year since the signing day on word.
Article 3: The drug mentioned in the Article 1 is allowed for use in the drug-addiction treating centers in Vietnam.
Article 4: the Applicant and Manufacturer in the Article 1 shall report all information related to the drug's safety and effectiveness to Vietnamese Department of Drug and Administration every 6 months.
Article 5: Directors of City and Province Health Service, Directors of Unites in the Article 1 are responsible for executing this Decision.
|
Recipients:
Minister of Health, Ass. Prof. Tran Thi Trung Chien
Ministry of Health inspectors
Analysis Institute
Vietnamese Pharmaceutical Corporation
Drug-addiction treating centers
City and Province Health Service
Military Health Department
Ministry of Police
Executive Department - Ministry of Health
Therapy Department - MoH
Department of Traditional Medicine- MoH
Central hospitals
Members of the Drug Review Council
|
Head of Vietnamese Department of Drug and Administration
(signed and sealed)
Mr. Cao Minh Quang |
