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

  • Summary
  • Content
  • Status
  • Vietnamese
  • Download
Save

Please log in to use this function

Send link to email

Please log in to use this function

Error message
Font size:

ATTRIBUTE

Decision No. 336/QD-BYT dated February 07, 2020 of the Ministry of Health 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
Issuing body: Ministry of HealthEffective date:
Known

Please log in to a subscriber account to use this function.

Don’t have an account? Register here

Official number:336/QD-BYTSigner:Truong Quoc Cuong
Type:DecisionExpiry date:Updating
Issuing date:07/02/2020Effect status:
Known

Please log in to a subscriber account to use this function.

Don’t have an account? Register here

Fields:Export - Import , Food and drug

SUMMARY

To pilot level 4 online public services with respect to procedures for licensing import of drugs

On February 07, 2020, the Minister of Health issues the Decision No. 336/QD-BYT 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.

Accordingly, from the date of signing of this Decision to June 30, 2020, to pilot the level 4 online public services with respect to procedures for licensing import of drugs without a registration certificate of circulation in Vietnam. To be specific:

After the effective date of this Decision, the enterprises selected by the Drug Administration shall participate in the pilot of the level 4 online public services with respect to procedures for licensing import of drugs without a registration certificate of circulation in Vietnam.

The Ministry of Health encourages enterprises that have not been selected in the pilot to submit online import orders of drugs without a registration certificate of circulation in Vietnam. During this period, such enterprises may choose to submit their applications by paper or online forms.

After the pilot period, to officially carry out the level 4 online public services with respect to procedures for licensing import of drugs without a registration certificate of circulation in Vietnam.

This Decision takes effect on the signing date.

For more details, click here.
Download files here.
LuatVietnam.vn is the SOLE distributor of English translations of Official Gazette published by the Vietnam News Agency
Effect status: Known

THE MINISTRY OF HEALTH
-------

No. 336/QD-BYT

THE SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------

Hanoi, February 07, 2020

 

 

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

----------------

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.

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

Please log in to a subscriber account to see the full text. Don’t have an account? Register here
Please log in to a subscriber account to see the full text. Don’t have an account? Register here
Processing, please wait...
LuatVietnam.vn is the SOLE distributor of English translations of Official Gazette published by the Vietnam News Agency

ENGLISH DOCUMENTS

LuatVietnam's translation
Decision 336/QĐ-BYT PDF

This utility is available to subscribers only. Please log in to a subscriber account to download. Don’t have an account? Register here

* Note: To view documents downloaded from LuatVietnam.vn, please install DOC, DOCX and PDF file readers
For further support, please call 19006192

SAME CATEGORY

loading