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.

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.

7. Issuance of the import license of drugs with the same trade names, active ingredient, content or concentration, dosage form with the generic brand name drugs that have the registration Certificate of circulation in Vietnam, manufactured by the same manufacturer of such generic brand name drugs or an authorized manufacturer, with the costs less than the costs of the generic brand name drugs circulating in Vietnam.

8. Issuance of the import license of drugs to serve the State health Programs.

9. Issuance of the import license of drugs for the purposes of humanitarian aid and support.

10. Issuance of the import license of combined drugs containing addictive substances, combined drugs containing psychotropic substances or combined drugs containing precursors for display at exhibitions and fairs related to medical, pharmaceuticals, medical equipment to exhibited at exhibitions and fairs.

Article 2. Responsibilities of units related to 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

1. Responsibility of the Drug Administration

1.1. To select enterprises participating in the pilot.

1.2. To take responsibility for ensuring the maintenance of regular and continuous operations; maintain and upgrade the level 4 online public service software with procedures for licensing import of drugs without a registration certificate of circulation in Vietnam to ensure infrastructure, technical measures, technologies, network security solutions, data security, troubleshooting and human resource training for the provision of online public services at level 4.

1.3. To promulgate the processes, time, settlement of applications and methods of submitting applications and returning results on the level 4 online public services for procedures for granting the import license for drugs without the registration certificate of circulation in Vietnam and must not exceed the time limit as prescribed in the administrative procedure set published by the Ministry of Health.

1.4. To return the results by electric documents, in which state the Drug Administration’s electric signatures and stamps used exclusively in the political granted by the Government Cipher Committee.

1.5. To publish the results of the procedures for issuance of import license of drugs without the registration certificate of circulation in Vietnam on the web portal of the Ministry of Health and the website of the Drug Administration.

1.6. To propagandize and guide organizations and individuals to use the public online services.

2. Responsibility of units directly participating in 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.

2.1. To provide information, documents and carry out administrative procedures through the electronic data processing system at the website of the Drug Administration and pay fees, charges and other revenues according to provisions of law.

2.2. To take responsibility before law for the accuracy and honesty of the declared contents and submitted applications unified content between paper applications and electronic applications that were created by enterprises.

2.3. To keep applications related to the procedures for issuance of the import license of drugs without the registration certificate of circulation in Vietnam and submit to relevant agencies as requested according to regulations of law.

Article 3. Expenses for the implementation, maintenance and guidance of the implementation of the level 4 public online services with the procedures for issuance of the import license of drugs without circulation registration certificate in Vietnam

Expenses for carrying out the level public online services with the procedures for issuance of the import license of drugs without circulation registration certificate in Vietnam shall be paid by the regular and annual spending source of the Drug Administration and other legal funds.

Article 4. Roadmap of implementation

1. The pilot period: 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.

2. 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.

Article 5. Implementation provisions

1. This Decision takes effect on the date of its signing.

2. The Director General of the Drug Administration, Director General of the Administration of Information Technology, the Chief of the Ministry s Office, Heads of units of the Ministry of Health and relevant organizations and individuals shall be responsible for the implementation of this Decision./.