Notificación ordinaria

     
 
12/05/2011
12/05/2011
17/05/2011
Viet Nam
THE MINISTRY OF HEALTH ;
138A – Giang Vo Str – Ba Dinh Pro – Ha Noi City – Viet Nam ;
Tel (84-4): 62732273 - Fax: 38464051 - Email: byt@moh.gov.vn ;

Notificado en virtud del artículo

 
 
 
 
 
 
 
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Médicaments
Medicamentos
Version Productos abarcados Interpreted
No hay nada actualmente en la base de datos
Productos abarcados Interpreted
No hay nada actualmente en la base de datos
Circular Guidelines for clinical drug trial
This circular prescribes guidelines on the types of drug that require clinical trials, clinical trial exemption, exemption of certain clinical trial stages; sequences, procedures, conditions, records, rights and obligations of the parties concerned, evaluation process, approval, development, monitoring, supervision, inspection and acceptance assessment for the clinical trial research in Vietnam in order to serve the study, and permit the circulation of drugs, vaccines and medical biologicals used for the diagnosis, treatment and prevention of diseases directly administered to a person (hereinafter referred to as drugs).
To ensure safety and health of users of Vietnam in diagnosis, treatment and prevention.













- Pharmacy Law dated 14/6/2005 ;
- Decree No 79/2006/ND-CP dated 09/8/2006 of the Government detailing the implementation of some articles of the Pharmacy Law ;
To be determined
To be determined
16/07/2011
60 days from date of notification

Notificación con un plazo para presentar observaciones

 
 
 
 

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