THE MINISTRY OF HEALTH
THE SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
Hanoi, February 07, 2020
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
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,
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.
3. Issuance of the import license of drugs to meet the urgent needs for national defense, security, prevention and control of disease, disaster and disaster recovery.
4. Issuance of the import license of drugs that have the outstanding efficiency in treatment comparing to the drugs currently circulating in Vietnam or there is no other alternative drugs; such drugs have been circulated in the manufacturing country or the reference country being ICH member country or Australia, with sufficient clinical data on safety, efficiency in accordance with regulations on the registration of drugs of the Minister of Health and were proposed to be used by the Advisory Council for issuance of the registration Certificate of circulation of drug and medicinal ingredients.
5. Issuance of the import license of rare drugs.
6. Issuance of the import license of drugs for the purposes of emergency, poison control without having the same active ingredients and route of administration as the drugs circulating in Vietnam and vaccines used in some special cases with the limited quantities shall be decided by the Minister of Health on the basis of the data that meets the requirements on quality, effectiveness and safety.
Click download to see the full text