View Procedure

Category      

Permission

Responsible Agency

MOH

Legal basis of the Procedure                

Law 105/2016/QH13

Decree 54/2017/NĐ-CP  (Article 85)

Processing time

3 working days

Fee

Item

Required document

1

03 original copy of the purchase order according to Form No. 36 or 41 in Appendix III Decree 54/2017/NĐ-CP

2

 If the ingredient is imported for production of drugs serving national defense and security, the original copy of the written request of the Ministry of National Defense or the Ministry of Public Security which specifies the drug name, the manufacturer’s name, active ingredients and concentration/content thereof, dosage form, package contents, route of administration and indications

3

 If the ingredient is imported for production of drugs serving epidemic control or disaster relief, a written approval for the list of drugs issued by the Ministry of Health which specifies the drug name, the manufacturer’s name, active ingredients and concentration/content thereof, dosage form, package contents, route of administration and indications

4

 If the ingredient is importer for production or concoction of drugs according to prescriptions at pharmacies or health facilities, the written request of the manufacturing facility or concocting facility according to Form No. 42 in Appendix III Decree 54/2017/NĐ-CP

5

The commitment to use the ingredient for intended purposes by the importer and the facility using the ingredient.

6

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

7

 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

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 3 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 3 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 Article 85 Decree 54/2017/NĐ-CP. If the supplemented application is satisfactory, the Ministry of Health shall issue the written permission to import