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Procedure Name

Licensing for importation of drugs/medicinal ingredients its remaining shelf life when customs clearance is shorter than specification

Description

Required documents

Item	Required document
1	The importer’s written request which specifies: name of the drug/medicinal ingredient, remaining shelf life when customs clearance is granted and explanation as to why its remaining shelf life is shorter than those specified in Clause 1 or Clause 2 of Article 90 Decree 54/2017/NĐ-CP
2	Documents proving that the remaining shelf life of the batch of drug/medicinal ingredient when customs clearance is granted is shorter than those specified in Clause 1 or Clause 2 of Article 90 Decree 54/2017/NĐ-CP

Process Steps

Step 1	The applicant shall submit an application to the Ministry of Health directly or by post
Step 2	After receiving the application, the Ministry 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 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;
Step 4	After receiving the supplemented application, the Ministry of Health shall give the applicant form No. 01 in Appendix I Decree 54/2017/NĐ-CP. 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 written permission to import . Within 03 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 04 months from the first time it is submitted, the application will be rejected

Conditions:

The applicant (enterprise) is one of the following:

Enterprise have been granted certificates of eligibility for pharmaceutical business, the scope of export and / or import of drugs, raw materials for manufacture of medicines or drugs
Enterprise have been granted import permits