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Procedure NameGranting permission to export/import patient specimens
Description
Category
License/Permit
Responsible Agency                   
 
Ministry of Health - General Department of Preventive Medicine
Address: Alley 135 Nui Truc street, Ba Dinh district, Hanoi
Phone: +844 3843 0040
Email:
Legal base of the Procedure
  • Circular 43/2011/TT-BYT the management of patient specimens of infectious diseases
Processing time
  • Within 10 working days from the date of reception of the adequate and valid dossier
Fee
 
 
Required Documents
No.
Type of documents
Note
1
Dossier of application for the import or export of specimens
01 original copy
2
The documentations proving the necessity of the import or export of specimens,  including the photocopy of the written approval issued by a ministerial or provincial competent authority for the research or project, and the outline of the research or project that is approved of, or the written agreement on the cooperation between a Vietnamese party and a foreign party relating to the import or export of specimens.
01 original copy
3
The photocopy of the Certificate of Business registration, Establishment Decision or other papers proving that the organization is licensed to export, import, research, preserve, transport, and test specimens.
01 photocopy
4
Where an organization licensed to research authorizes another eligible organization to import or export specimens, the dossier must contain the contract signed by both of them.
01 original copy
 
Process Steps
Step 1
 
The applicant shall submit 01 dossier set of original documents/materials to the General Department of Preventive Medicine (Department of Vaccines and Testing Management)
Step 2
If the dossier is complete or valid, the General Department of Preventive Medicine shall: within 10 working days from the day on which the complete and valid dossier is received, issue a written decision to grant or not to grant the Permit to import or export the patient specimens. If the dossier is incomplete or not valid, the General Department of Preventive Medicine shall within 10 working days notify such in writing to the applicant for supplementation of the dossier
Step 3
If the final dossier is satisfactory and eligible, the General Department of Preventive Medicine shall make the decision to grant the Permit to import or export the patient specimens. In case of rejection, relevant reasons shall be clearly stated
 
Process Map:
CategoryProcedure

The following form/s are used in this procedure
TitleDescriptionCreated DateUpdated DateIssued By
Annex 7 Circular 43/2011/TT-BYT Applicant for import/export specimens01-07-201601-07-2016Ministry of HealthThis is Dowload File
This procedure applies to the following measures
NameMeasure TypeAgencyDescriptionCommentsLegal DocumentValidity ToMeasure Class
Import and export of specimensLicensing RequirementMinistry of HealthImport and export of specimensImport and export of specimensCircular 43/2011/TT-BYT on the management of infectious specimens.31-12-9999Good