View Procedure

Category      

Permission

Responsible Agency

MOH

Legal basis of the Procedure                

Law 105/2016/QH13

Decree 54/2017/NĐ-CP  (Article 71)

Processing time

within 60 days if clinical documents and documents proving equivalence to reference biologicals are not required, or within 90 days if clinical documents and documents proving equivalence to reference biological are required.

Fee

Item

Required document

1

3 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 a certified true copy of the certificate of pharmaceutical product;

3

Quality documents according to regulations of the Minister of Health on use of ACTD for drug registration

4

Clinical document if required by regulations of the Minister of Health on use of ACTD for drug registration

5

 The original copy of 01 set of specimens of the label and package insert of the drug licensed for free sale in the country that issues the certificate of pharmaceutical product, unless they are already attached to the certificate of pharmaceutical product;

6

02 sets of specimens of the labels intended to be used in Vietnam and the package insert in Vietnamese language which bear the importer’s sea

7

The original copy or certified true copy of the written approval issued by a competent authority for use of the drug for the health program of the State

8

The original copy or certified true copy of the certificate of GMP of all facilities participating in the manufacture of the imported drug if the drug is manufactured by more than one facility

9

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.

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 60 days if clinical documents and documents proving equivalence to reference biologicals are not required, or within 90 days if clinical documents and documents proving equivalence to reference biological are required. The import license shall be issued on the basis of counsel given by the certification advisory council;

If the application is not satisfactory, the Ministry of Health shall request the applicant in writing to complete it within 60 days if clinical documents and documents proving equivalence to reference biological are not required, or within 90 days if clinical documents and documents proving equivalence to reference biologicals are required;

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