Category      

Permission

Responsible Agency

MOH

Legal basis of the Procedure                

Law 105/2016/QH13

Decree 54/2017/NĐ-CP  (Article 80)

Processing time

15 working days

Fee

Item

Required document

1

01 original copy of the purchase order according to Form No. 35 or 36 in Appendix III Decree 54/2017/NĐ-CP

2

A copy of the document about the quality standards and medicinal ingredient testing method of the manufacturer which bears the importer’s seal;

3

A certified true copy of the manufacturing license issued by a competent authority of the exporting country. The manufacturing license shall be consularly legalized in accordance with regulations of law on consular legalization, except for the cases in which consular legalization is exempted by law;

4

A report on use of medicinal ingredients other than toxic medicinal ingredients according to Form No. 37 in Appendix II enclosed herewith and the report on sale of medicinal ingredients other than toxic medicinal ingredients according to Form No. 38 in Appendix III Decree 54/2017/NĐ-CP

5

The plan for production of use of the ingredients and plan for sale of products derived from such ingredients, except toxic ingredients

6

If the medicinal ingredients have to be imported for testing or research, the original copy of the importer’s document specifying the purposes and quantity of ingredients to be imported and the commitment to use them for intended purposes;

7

In the cases where a controlled medicinal ingredient that does not have the certificate of registration in Vietnam or not on the list of active ingredients, excipients or semi-finished drugs used for production of drugs that are already granted the certificate of drug registration in Vietnam is imported to concoct prescription drugs by pharmacies or health facilities serving epidemic control, the concocting facility’s written request according to Form No. 39 in Appendix III  Decree 54/2017/NĐ-CP

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 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