View Procedure

Procedure NameGranting permission to import finished addictive drugs, psychotropic substances, precursor substances with registration numbers for circulation
Description
Category
License/Permit
Responsible Agency         
Drug Administration of Vietnam - Ministry of Health
Address:
Phone:
Email:
Legal Basis of the Procedure                   
  • Law on Pharmacy No. 105/2016/QH13   
  • Decree 102/2016/ND-CP on Drug business requirements
  • Decision 151/2007/QD-TTg dated September 12, 2007 promulgating the Regulation on the Import of Drugs without Registration Numbers in Vietnam                
  • Circular 19/2014/TT-BYT dated June 02, 2014, management of addictive drugs, psychotropic drugs, and drug precursors                    
  • Circular 47/2010/TT-BYT dated December 29, 2010 of the Ministry of Health guiding the export, import of medicines and packaging in direct contact with medicines                            
 
Processing time
  • Within 15 working days from the date of reception of valid and sufficient dossier.
Fee
VND 0
 
Required Documents
No.
Type of Document
Remarks
1
Import orders for finished addictive drugs (or psychotropic substances, precursor substances) with registration numbers
01 original copy
2
Inventory report of finished addictive drugs (or psychotropic substances, precursor substances)
01 original copy
 
 
Process Steps
Step 1
The applicant shall submit a dossier of Application to the Drug Administration of Vietnam - Ministry of Health
Step 2
The Drug Administration of Vietnam shall receive and examine the dossier.
Step 3
 
The Administration shall inform the applicant of the results. In case of refusal, the Administration shall reply in writing and clearly state relevant reasons.
 
Process Map:
 
 
CategoryProcedure

The following form/s are used in this procedure
TitleDescriptionCreated DateUpdated DateIssued By
Form 2a - List of import addictive products line have registered number28-05-201631-05-2016Ministry of HealthThis is Dowload File
Form 4 - Addictive inventory report28-05-201609-06-2016Ministry of HealthThis is Dowload File
This procedure applies to the following measures
NameMeasure TypeAgencyDescriptionCommentsLegal DocumentValidity ToMeasure Class
Importing finished addictive drugs, psychotropic substances, precursor substances bearing sale numbersPermit RequirementMinistry of HealthActivities related to addictive drugs used in medicine, analysis, testing, and scientific research enumerated in the List of Addictive drugs Importing finished addictive drugs, psychotropic substances, precursor substances bearing sale numbers Circular 19/2014/TT-BYT Management of addictive drugs, psychotropic drugs, and drug precursors01-07-2017Good
Importing finished products containing addictive elements bearing sale registration numbersPermit RequirementMinistry of HealthFinished drugs containing various active elements and substances in which an addictive substance is combined with other substances (that are not addictive drugs, psychotropic substances, precursor substances ) Importing finished products containing addictive elements bearing sale registration numbers Circular 19/2014/TT-BYT Management of addictive drugs, psychotropic drugs, and drug precursors31-12-9999Good