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| Procedure Name | Licensing drugs that have the same trade name, active ingredients, concentration and dosage form as those of a proprietary drug having the certificate of drug registration in Vietnam, are manufactured by the same manufacturer of the proprietary drug... |
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| Description |
Required documents
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Item
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Required document
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1
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03 copies of the purchase order according to Form No. 15, 16 or 17 in Appendix III Decree 54/2017/NĐ-CP
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2
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The importer’s commitment to drug quality and intended wholesale price;
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3
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Documents proving that the drug is licensed for free sale in the manufacturing country or a reference country
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4
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01 set of specimens of the label and package insert of the drug licensed for free sale in manufacturing country which bear the importer’s seal;
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5
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02 sets of specimens of the secondary label and package insert in Vietnamese language which bear the importer’s seal. The content of the package insert in Vietnamese language must be consistent with the content of the label of the proprietary drug approved by the Ministry of Health regarding
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Process Steps
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Step 1
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The applicant shall submit an application to the Ministry of Health directly or by post
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Step 2
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After receiving the application, the Ministry of Health shall give the applicant form No. 01 in Appendix I Decree 54/2017/NĐ-CP
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Step 3
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If the application is satisfactory, the Ministry of Health shall issue the import license within 15 working days from the day on which the application is received;
If the application is not satisfactory, the Ministry of Health shall request the applicant in writing to complete it within 15 working days from the day on which it is received
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Step 4
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After receiving the supplemented application, the Ministry of Health shall give the applicant form No. 01 in Appendix I enclosed herewith. If the application is still unsatisfactory, the Ministry of Health shall request the applicant to complete it in accordance with Point d this Article. If the supplemented application is satisfactory, the Ministry of Health shall issue the import license.
Within 06 months from the day on which additional documents are requested in writing by the Ministry 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 12 months from the first time it is submitted, the application will be rejected
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Conditions:
The import of such a drug shall only be licensed when the following requirements are satisfied:
- Requirements in Clause 2dd Article 60 of the Law on Pharmacy are satisfied;
- The intended wholesale price is lower by at least 20% than the successful bid for the proprietary drug having the certificate of registration in Vietnam;
- The drug is licensed and exported to Vietnam from the manufacturing country, a reference country that is a member state of the ICH or Australia;
- The drug is not a radiopharmaceutical, vaccine or biological.
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| Category | Procedure |
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The following form/s are used in this procedure
This procedure applies to the following measures
| Name | Measure Type | Agency | Description | Comments | Legal Document | Validity To | Measure Class |
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