Quyết định 5480/QD-BYT

DECISION

DEPLOYMENT OF LEVEL-4 ONNLINE DRUG REGISTRATION SERVICES

MINISTER OF HEALTH

Pursuant to the Pharmacy Law No. 34/2005/QH11 dated June 14, 2005;

Pursuant to the Electronic Transactions Law No. 51/2005/QH11 dated November 29, 2005;

Pursuant to the Information Technology Law No. 67/2006/QH11 dated June 29, 2006;

Pursuant to the Government’s Decree No. 64/2007/ND-CP dated April 10, 2007 on the application of information technology in government authorities’ activities;

Pursuant to the Government’s Decree No. 43/2011/ND-CP dated June 13, 2011 on the provision of information and online services on websites or portals of government authorities; 

Pursuant to the Government's Decree No. 72/2013/ND-CP dated July 15, 2013 on the management, provision and utilization of Internet-based services and online data;

Pursuant to the Government’s Decree No. 63/2012/ND-CP dated August 31, 2012 on functions, missions, authority and organizational structure of the Ministry of Health;

At the request of the Head of the Drug Administration of Vietnam.

DECIDES:

Article 1. Scope and regulated entities

1. The online level-4 online drug registration services shall govern every activity concerning drug registration.

2. Drug Administration of Vietnam and organizations involved in online numbering of drugs for free sale, and enterprises registering drugs online.

Article 2. Responsibilities of organizations providing online level-4 online drug registration services

1. Responsibilities of the Drug Administration of Vietnam

a. Take responsibilities for assurance and continuation of constant and uninterrupted operation; for maintenance and upgrade of software for online level-4 online drug registration services; for sustenance of technical and technological infrastructure and measures, safety solutions, network and data security; for rectification of problems and training of personnel to provide level-4 online services.

b. Promulgate procedures and time for submission and processing of applications and provision of decisions through the online level-4 online drug registration services in conformity to the time limit as defined in the Ministry of Health's regulations on administrative procedures.

Written decisions given in electronic format through the online services shall bear signature(s) and official seal generated by the political digital signature that the Cipher Commission issues to the Drug Administration of Vietnam.

c. Publish the results of the online level-4 online drug registration services on the portals of the Ministry of Health and the Drug Administration of Vietnam.

d. Propagate information and provide guidelines to organizations and enterprises using the online services.

2. Responsibilities of organizations and enterprises using the online level-4 online drug registration services

a. Provide information and documents, fulfill administrative formalities through the electronic data processing system on the portal of the Drug Administration of Vietnam and pay fees as per the laws.

b. Assume liabilities to the law for the accuracy and integrity of information declared and documents lodged, and the consistency of the physical application and the electronic application that the enterprise has made.

c. Retain and present documents concerning drug registration to relevant authorities upon request according to the laws.

Article 3. Budget for deployment and maintenance of online level-4 online drug registration services and relevant guidelines

The costs of deployment of the online level-4 online drug registration services shall be covered by the annual budget of the Drug Administration of Vietnam and other legitimate sources.

Article 4. Deployment

1. From January 01, 2016 to December 31, 2016, pilot provision of online drug registration services shall be available for applications for first-time drug registration. After the pilot period, the Drug Administration of Vietnam shall assess the result and complete procedures for official deployment.

Ministry of Health encourages organizations to register drugs online. During the pilot period, enterprises may submit their applications physically or online. The applications filed both physically and online shall be separately and simultaneously processed.

2. As of January 01, 2017, online drug registration services shall be available for applications for re-registration, extension and changes.

Article 5. Implementation

1. This decision takes effect from the date that it is signed.

2. Head of Drug Administration of Vietnam, Office Manager of the Ministry, Heads of units under the Ministry of Health and organizations concerned are responsible for implementing this Decision./.