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Procedure Name

Granting permission to import raw materials for addictive drugs/medicines

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. 105/2016/QH13 Decision 151/2007/QD-TTg dated September 12, 2007, promulgating the Regulation on the Import of Drugs without Registration Numbers in Vietnam Circular 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	Import order (Form 12d);	01 original copy
2	Inventory report of finished addictive drugs (or psychotropic substances, precursor substances) (Form 3)	01 original copy
3	Quality standards (for raw materials not subject to the quality standards of the Pharmacopeia)	01 original copy (if any)

Conditions:

Central Pharmaceutical Company 1, Central Pharmaceutical Company 2, 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.

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

Title	Description	Created Date	Updated Date	Issued By
Form 4 - Addictive inventory report	Form 4 - Addictive inventory report	28-05-2016	09-06-2016	Ministry of Health
Form 2d List of imported addictive drugs material	Form 2d List of imported addictive drugs material	07-06-2016	09-06-2016	Ministry of Health

This procedure applies to the following measures

Name	Measure Type	Agency	Description	Comments	Legal Document	Validity To	Measure Class
Importing addictive materials and precursor substances	Permit Requirement	Ministry of Health	Importing addictive materials and precursor substances	Importing addictive materials and precursor substances	Circular 47/2010/TT-BYT Guiding the export, import of medicines and packaging directly contacted with medicines	31-12-9999	Good