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| Procedure Name | Licensing for import of drugs for the purpose of clinical trial, bioequivalence study, bioavailability assessment, testing or scientific research |
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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 original copy or certified true copy of the written approval issued by a competent authority or organization in the cases mentioned in Clause 1a, 1b and 1dd of Article 73 Decree 54/2017/NĐ-CP
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3
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The original copy or certified true copy of the written approval for the bioequivalence study outline according to Article 100 of the Law on Pharmacy in case of a new drug mentioned in Clause 1c of Article 73 Decree 54/2017/NĐ-CP.
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4
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The importer’s document bearing the importer’s seal specifying the purposes and quantity of imported drugs and commitment to use the drugs for intended purposes
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5
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A copy (authenticated or bearing the importer’s seal) of the importer’s license to perform radiological works in case of import of radiopharmaceuticals. If a copy bearing the importer’s seal is submitted, the original copy shall be produced for comparison when the application is submitted.
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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 written permission to import 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 one of the following requirements is satisfied:
a) The drug is used for clinical trial under a research outline approved by the Minister of Health according to Clause 1 Article 94 of the Law on Pharmacy;
b) The drug is used for bioequivalence study or bioavailability assessment in Vietnam under an approved research outline according to Clause 1 Article 100 of the Law on Pharmacy;
c) The drug is used as a reference drug in bioequivalence study. If the reference drug is a new drug, it may only be used under an approved research outline according to Clause 1 Article 100 of the Law on Pharmacy;
d) The drug is used for testing by drug manufacturers or drug-testing laboratorie
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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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