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Procedure NameGranting permission to import vaccines and medical biological products without registration numbers for circulation
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
  • 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 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 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 5d)
01 original copy
2
Certificate of Pharmaceutical Product (CPP) or domestically-granted Certificate of Free Sale (FSC) and GMP certification
01 original copy
3
Standards and testing methods
01 original copy
4
Set of labels intended to be put in circulation in Vietnam enclosed with user guides already translated into Vietnamese.
02 original copy
5
Pre-clinical and clinical records for drugs containing new pharmaceutical substances, drugs with new combinations of circulating pharmaceutical substances.
01 original copy
 
Conditions:
Vaccines, medical biological products without registration numbers, when imported into Vietnam they must have a remaining expiry date of at least by 2/3 of expiry date from the date of arrival in Vietnam
 
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 5d List of imported vaccine and medical biological without registration numberForm 5d List of imported vaccine and medical biological without registration number03-06-201603-06-2016Ministry of HealthThis is Dowload File
Form 5đ List of import medical biology products without registration numberForm 5đ List of import medical biology products without registration number03-06-201603-06-2016Ministry of HealthThis is Dowload File
This procedure applies to the following measures
NameMeasure TypeAgencyDescriptionCommentsLegal DocumentValidity ToMeasure Class
Importing vaccines and medical biological products without registration numbersPermit RequirementMinistry of HealthVaccines and medical biological products without registration numbers, when imported into Vietnam must have a remaining expiry date of at least 2/3 of expired date from the date of arrival at a Vietnam's portImported vaccines and medical biological products without registration numbersDecision 151/2007/QD-TTg of September 12, 2007, promulgating the regulation on the import of drugs without registration number in Vietnam31-12-9999Good