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Procedure NameLicensing for export of controlled drugs The drug is personal property shipped under a lading bill or the outbound passenger’s belongings for treatment of his/her own disease and is not an ingredient of controlled drugs
Description

Category      

Permission

Responsible Agency

MOH

Legal basis of the Procedure                

Law 105/2016/QH13

Decree 54/2017/NĐ-CP  (Article 60)

Processing time

7 working days

Fee

Required documents

Item

Required document

1

 Form No. 07 in Appendix III Decree 54/2017/NĐ-CP

2

Copies of the prescription and outpatient's medical record which is authenticated or bears the applicant’s signature (if the applicant is an individual) or seal (if the applicant is an organization). These documents shall specify the patient’s name and age; name, concentration and quantity (or doses) of the drug; dosage; the physician’s name and signature, address of the hospital or clinic where the physician practices.

If a copy bearing the applicant’s signature of seal is submitted, the original copy shall be produced for comparison when the application is submitted;

3

 A copy of the applicant’s ID card or passport which is authenticated or bears the applicant’s signature.

If a copy bearing the applicant’s signature is submitted, the original copy shall be produced for comparison when the application is submitted;

4

If any of the documents mentioned in Points 2,3 of this Clause is written in a language other than Vietnamese or English language, a notarized Vietnamese or English translation shall be included.

Process Steps

Step 1

The applicant shall submit an application, directly or by post, to Department of Health of the province where the exit checkpoint is located or where the patient is residing or where the applicant’s headquarters are located

Step 2

After receiving the application, the Department of Health shall give the applicant form No. 01 in Appendix I Decree 54/2017/NĐ-CP

Step 3

 If the application is satisfactory, the Department of Health shall issue the export license within 07 working days from the day on which the application is received;If the application is not satisfactory, the Department of Health shall request the applicant in writing to complete the application within 05 working days from the day on which the application is received;

Step 4

After receiving the supplemented application, the Department of Health shall give the applicant form No. 01 in Appendix I Decree 54/2017/NĐ-CP. If the application is still unsatisfactory, the Department of Health shall request the applicant to complete it in accordance with Point d of this Clause. If the supplemented application is satisfactory, the Department of Health shall issue the export license;

 Within 03 months from the day on which additional documents are requested in writing by the Department of Health, the applicant shall submit additional documents as requested. If the applicant fails to satisfy such request by the aforementioned deadline or the application is not satisfactory within 04 months from the first time it is submitted, the application will be rejected.

 

 Conditions:

  1. The non-commercial export of a controlled drug shall be granted when the drug is licensed for sale in Vietnam and The drug is personal property shipped under a lading bill or the outbound passenger’s belongings for treatment of his/her own disease and is not an ingredient of controlled drugs
  2.  A license must be obtained before drugs are exported, except for those mentioned in Clause 1a of this Article if the quantity does not exceed:
    1. 07 days’ dose for narcotic drugs according to the prescription;
    2. 10 days’ dose for psychotropic drugs and precursors according to the prescription;
    3.  30 days’ dose for combined drugs that contain narcotic active ingredients or psychotropic active ingredients, toxic drugs, drugs on the list of banned substances in certain fields according to the prescription.
  3. Applicant(s) is outbound passenger
CategoryProcedure

The following form/s are used in this procedure
TitleDescriptionCreated DateUpdated DateIssued By
Specimen No. 7 - APPLICATION FOR SPECIAL CONTROLLING EXEMPTION DRUGS NOT FOR COMMERCIAL PURPOSES04-05-201804-05-2018Ministry of HealthThis is Dowload File
This procedure applies to the following measures
NameMeasure TypeAgencyDescriptionCommentsLegal DocumentValidity ToMeasure Class
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