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Procedure NameGranting permission to import finished drugs 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 5a)
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
Original labels enclosed with the user guides in actual circulation in the country of origin
01 original copy
5
Set of labels intended to be put in circulation in Vietnam enclosed with user guides already translated into Vietnamese.
02 original copy
6
Pre-clinical and clinical records for drugs containing new pharmaceutical substances, drugs with new combinations of circulating pharmaceutical substances.
01 original copy
 
Conditions:
a) Drugs composed of pharmaceutical ingredients of groups with pharmacological effects or preparation forms with few registration numbers for circulation in Vietnam according to the list of drugs with registration number for circulation in Vietnam in each period; 
 
b) Drugs composed of pharmaceutical ingredients without registration numbers for circulation in Vietnam:
- Drugs composed of pharmaceutical ingredients with registration number for circulation in Vietnam but at the time of submission of import dossiers, these registration numbers have expired without registration renewal;
- Drugs composed of pharmaceutical ingredients which have been permitted for circulation in other countries but are not yet been granted a registration number in Vietnam, except new pharmaceutical ingredients;
Rare drugs, specific drugs or drugs of special preparation forms which cannot be yet manufactured in Vietnam.
(Clause 2 Article 7 of Decision No.151/2007/QD-TTg dated September 12, 2007 of the Prime Minister stipulating on the import of drugs/medicines without registration numbers in Vietnam).
Finished drugs imported into Vietnam with expiry date of more than 24 months, the remaining expiry date must be at least 18 months from the date of arrival in Vietnam. For drugs with expiry date of equal to or less than 24 months the remaining expiry date must be at least 12 months from the date of arrival in Vietnam;
 
 
Process Steps
Step 1
The applicant shall submit the dossier to the Drug Administration of Vietnam - Ministry of Health.
Step 2
The Administration 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 5c List of import finished drugs without registration number01-06-201601-06-2016Ministry of HealthThis is Dowload File
This procedure applies to the following measures
NameMeasure TypeAgencyDescriptionCommentsLegal DocumentValidity ToMeasure Class
Importing finished drugs without registration numbersPermit RequirementMinistry of HealthDrugs with pharmaceutical ingredients without registration numbers or with registration numbers but insufficient to meet medical treatment needs Importing finished drugs 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