View Procedure
Procedure Name | Granting permission to export finished addictive drugs, psychotropic substances, precursor substances with/without registration numbers |
Description |
Category
|
License/Permit
|
Responsible Agency
|
Drug Administration of Vietnam - Ministry of Health
Address:
Phone:
Email:
|
Legal base of the Procedure
|
-
Law on Pharmacy No. 34/2005/QH11
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Decree No. 79/2006/ND-CP
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Circular No. 10/2010/TT-BYT dated April 29, 2010 guiding activities related to addictive drugs
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Circular No. 11/2010/TT-BYT dated April 29, 2010 of the Ministry of Health guiding activities related to psychotropic substances and precursor substances
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Circular No. 45/2011/TT-BYT amending and supplementing a number of articles in documents regulating pharmaceutical and cosmetic industries.
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Circular No. 47/2010/TT-BYT dated December 29, 2010 of the Ministry of Health guiding the export, import of drugs/medicines and packaging in direct contact with drugs/medicines
|
Processing time
|
-
Within 15 working days from the date of reception of adequate and valid dossier
|
Fee
|
VND 0
|
Required documents:
No
|
Type of documents
|
Note
|
1
|
Export order (Form 13a)
|
01 original copy
|
2
|
Written permission for import of the competent authority of the importing country;
|
01 original copy
|
Requirements and conditions in following administrative procedures:
Central Pharmaceutical Company 1, Central Pharmaceutical Company 2, Central Pharmaceutical Company 3, SAFACO, YTECO, HAPHARCO. are entities entitled to export raw materials for addictive drugs, psychotropic substances and precursor substances
|
Process Steps
Step 1
|
The applicant shall submit a dossier of Application to the Drug Administration of Vietnam - Ministry of Health
|
Step 2
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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 |
Exporting addictive raw materials, psychotropic substances, precursor substances | Licensing Requirement | Ministry of Health | Exporting addictive raw materials, psychotropic substances, precursor substances
| Exporting addictive raw materials, psychotropic substances, precursor substances | Circular 19/2014/TT-BYT Management of addictive drugs, psychotropic drugs, and drug precursors | 01-07-2017 | Good |
Exporting finished addictive drugs, psychotropic substances, precursor substances with registration numbers | Licensing Requirement | Ministry of Health | Exporting finished addictive drugs, psychotropic substances, precursor substances with registration numbers | Exporting finished addictive drugs, psychotropic substances, precursor substances with registration numbers requires permits before export. | Circular 19/2014/TT-BYT Management of addictive drugs, psychotropic drugs, and drug precursors | 01-07-2017 | Good |
Exporting materials, finished addictive drugs, psychotropic substances, precursor substances without registration numbers | Licensing Requirement | Ministry of Health | Exporting materials, finished addictive drugs, psychotropic substances, precursor substances without registration numbers | Exporting materials, finished addictive drugs, psychotropic substances, precursor substances without registration numbers | Circular 19/2014/TT-BYT Management of addictive drugs, psychotropic drugs, and drug precursors | 01-07-2017 | Good |
Exporting materials, finished addictive drugs, psychotropic substances, precursor substances without registration numbers in combination form | Licensing Requirement | Ministry of Health | Exporting materials, finished addictive drugs, psychotropic substances, precursor substances without registration numbers in combination form
| Exporting materials, finished addictive drugs, psychotropic substances, precursor substances without registration numbers in combination form
| Circular 19/2014/TT-BYT Management of addictive drugs, psychotropic drugs, and drug precursors | 01-07-2017 | Good |
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