View Procedure

Category      

Permission

Responsible Agency

MOH

Legal basis of the Procedure                

Law 105/2016/QH13

Decree 54/2017/NĐ-CP  (Article 67)

Processing time

3 working days

Fee

Item

Required document

1

03 copies of the purchase order according to Form No. 15, 16 or 17 in Appendix III Decree 54/2017/NĐ-CP

2

The original copy or certified true copy of the certificate of pharmaceutical product or a confirmation that the drug is licensed in at least one other country issued by the exporting country’s competent authority

3

The original copy or a copy bearing the issuer’s seal of the written request or approval Decree  54/2017/NĐ-CP which specifies: the active ingredients of the modern drug or herbal ingredients of the herbal drug or traditional drug, dosage form, concentration of active ingredients of the modern drug or quantity of herbal ingredients of the herbal drug or traditional drug, package contents, manufacturer and manufacturing country

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 import license within 03 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 03 working days from the day on which the application 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 import license in accordance with Point c of Clause 67 Decree 54/2017/NĐ-CP

Step 5

Within 10 (ten) working days as from the date of licensing the import of drugs, the Ministry of Health shall have to publish such information on the electronic portal of the unit, including information on importers, manufacturers, serial numbers quantity, name of drug and number of import permit, number of circulation registration certificate for each active substance.