Decision No. 336/QD-BYT 2020 implementation of level 4 online public services for procedures for licensing import of drugs

DECISION

On the pilot of implementation of level 4 online public services with respect to procedures for licensing import of drugs without a registration certificate of circulation in Vietnam

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THE MINISTER OF HEALTH

Pursuant to the Law on Pharmacy No. 105/2016/QH13 dated April 06, 2006;

Pursuant to the Law on E-Transactions dated November 29, 2005;

Pursuant to the Law on Information Technology dated June 29, 2006;

Pursuant to the Government’s Decree No. 64/2007/ND-CP dated April 10, 2007 on information technology application in State agencies' operations;

Pursuant to the Government’s Decree No. 75/2017/ND-CP dated June 20, 2017 on defining the functions, tasks, powers and organizational structure of the Ministry of Health;

Pursuant to the Decision No. 2185/QD-TTg dated November 14, 2016 of the Prime Minister on approving the master plan of implementing National Single Window and ASEAN Single Window in the period of 2016 - 2020;

Pursuant to the Decision No. 1254/QD-TTg dated Approving the action plan to promote the National Singe Window mechanism and the ASEAN Single Window mechanism, reform of specialized inspection of exports and imports and trade facilitation during 2018-2020;

At the proposal of Director General of the Drug Administration,

DECIDES:

Article 1. Scope and subjects of application

To apply and deploy the pilot implementation of level 4 online public services with activities related to licensing the import of drugs without a registration certificate of circulation in Vietnam by the Drug Administration an organizations and individuals that submit import orders, including the following procedures:

1. Issuance of the import license of drugs containing pharmaceutical substances without a registration certificate of circulation in Vietnam, drugs containing medicinal ingredients for the first time in Vietnam.

2. Issuance of the import license of drugs containing pharmaceutical substances that already had a registration Certificate of circulation in Vietnam but have not yet met enough need for treatment, drugs containing medicinal ingredients that have been used as drugs in Vietnam but have not yet met enough need for treatment.

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