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Procedure NameGranting permission to import finished addictive drugs, psychotropic substances and precursor substances without registration numbers for circulation under the specific needs of a hospital
Description
Category
Procedure for licensing
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 promulgating the Regulation on the Import of Drugs without Registration Numbers in Vietnam   
  • Circular 19/2014/TT-BYT management of addictive drugs, psychotropic drugs, and drug precursors
  • Circular 47/2010/TT-BYT guiding the export, import of drugs/medicines and packaging in direct contact with drugs/medicines
Processing time
  • Within 20 working days from the date of reception of adequate and valid dossier
Fee
  • VND 0
 
Required documents:
No
Type of documents
Note
1
Import order (Form 5a and Form 5b) which specifies the import under specific needs of a hospital
01 original copy
2
Provisions/plans of the hospital
01 original copy
3
Inventory report of addictive drugs
01 original copy
 
Conditions:
1
Central Pharmaceutical Company 3, SAFACO, YTECO, HAPHARCO are responsible for the supply of addictive ingredients and finished addictive drugs to the sellers and users nationwide.
2
Central Pharmaceutical Company 1, Central Pharmaceutical Company 2, Central Pharmaceutical Company 3, SAFACO, YTECO, HAPHARCO are responsible for the supply of psychotropic substances and precursor substances to the sellers and users nationwide.
 
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 5a - List of import addictive products line hasn't registered yetForm 5a - List of import addictive products line hasn't registered yet31-05-201631-05-2016Ministry of HealthThis is Dowload File
Form 5b - List of import drugs containing addictive haven't registeredList of import drugs containing addictive haven't registered in the list of the combination31-05-201601-06-2016Ministry of HealthThis is Dowload File
Buying plan for addictive drugsBuying plan for addictive drugs31-05-201631-05-2016Ministry of HealthThis is Dowload File
This procedure applies to the following measures
NameMeasure TypeAgencyDescriptionCommentsLegal DocumentValidity ToMeasure Class
Importing unregistered addictive drugs under the specific needs of the hospitalPermit RequirementMinistry of HealthActivities relating to addictive drugs used in medicine, analysis, testing, and scientific research without registration numbers Importing unregistered addictive drugs under the specific needs of the hospital Circular 19/2014/TT-BYT Management of addictive drugs, psychotropic drugs, and drug precursors01-07-2017Good