View Procedure
Procedure Name | Granting 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:
|
Category | Procedure |
The following form/s are used in this procedure
This procedure applies to the following measures
Name | Measure Type | Agency | Description | Comments | Legal Document | Validity To | Measure Class |
Importing finished addictive drugs, psychotropic substances, precursor substances bearing sale numbers | Permit Requirement | Ministry of Health | Activities 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 precursors | 01-07-2017 | Good |
Importing finished products containing addictive elements bearing sale registration numbers | Permit Requirement | Ministry of Health | Finished 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 precursors | 31-12-9999 | Good |
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