Công văn 1178/QLD-ĐK năm 2016 hướng dẫn triển khai dịch vụ công mức độ 4 trong lĩnh vực đăng ký thuốc do Cục Quản lý Dược ban hành

To: Organizations registering drugs for free sale in Vietnam

On December 23, 2015, Minister of Health issued the Decision No. 5480/QD-BYT on deployment of the public service of level 4 in drug registration. Drug Administration of Vietnam provides the following guideline for pilot deployment of the online public service in drug registration for initial applications lodged from January 01, 2016 to December 31, 2016:

I. Important steps of online drug registration

1. Creation of an account for online drug registration

1.1. Requirements for account creation

An account for online drug registration shall only be granted to an organization whose appears as the applicant in the application for new drug registration. To create an account for online drug registration, the applicant must provide these legal documents:

- Certificate of eligibility for pharmacy business, in case of a Vietnamese applicant;

- License for establishment of representative office in Vietnam or Registration of operations in drug and medicinal ingredients in Vietnam (issue date before January 15, 2015), in case of a foreign applicant.

1.2. Account registration

The applicant enters the online drug registration system via the “Hệ thống tiếp nhận và xử lý thủ tục đăng ký thuốc” (System for submission and processing of drug applications) on http://dav.gov.vn, then fill in the form and upload color scans of the original of the "Certificate of eligibility for trading of drug" or "License for establishment of representative office in Vietnam” or “Registration of operations in drug and medicinal ingredients in Vietnam" accordingly for the Drug Administration of Vietnam to verify the account.

1.3. Account creation: In 02 days upon its receipt of the account request and legal documents attached, the online drug registration account division - Drug Administration of Vietnam shall verify the account, whose login detail (login name and password) shall be sent by the system to the email address given by the applicant. The system shall automatically inform the applicant of reason(s) of any rejection.

1.4. The applicant must sign up for the account once upon its initial activities and such account shall be used for drug registration/ If legal documents are amended, the applicant must modify information in the system and upload the amended paper in a manner similar to that of the initial account creation. The applicant must change the default password before using the account for relevant activities in order to maintain security.

2. The application for online drug registration

Requirements for administrative and technical documents in an application for online drug registration shall adhere to the Circular No. 44/2014/TT-BYT dated November 24, 2014 by Ministry of Health on drug registration. The application shall be lodged in the following manner:

2.1. Online submission:

1) The forms and cover page of the application: Filling out online forms as defined in the Circular No. 44/2014/TT-BYT.

2) Other documents: Upload files in formats such as pdf, doc or jpeg to the online drug registration system.

2.2 Manual submission (or by post) of documents to the Drug Administration of Vietnam with the admission code given upon online submission:

1) Legal documents including: The filled-out form of application (if such form does not bear electronic signature and seal); Certificate of pharmaceutical products (CPP), Certificate of good manufacturing practice (GMP), license(s) for production and trading of pharmaceutical products, license for establishment of representative office, other legal documents (if any). The applicant may not submit legal papers issued by the Ministry of Health of Vietnam (Drug Administration of Vietnam).

2) Drug sample

Time for direct submission of documents and drug sample(s): The applicant can submit such documents and samples after online submission succeeds and before the payment of registration fee completes according to the system’s notification.

3. Payment of application fee

Upon successful online submission, the system shall automatically notify the fee payable, which the applicant must pay in no later than 30 days upon the completion of online submission. The application processing time shall start from the date that drug registration fee is paid fully.

During the pilot service, the applicant may pay the fee by bank transfer or in cash at the Drug Administration of Vietnam as per the procedure in effect.

4. Notification of online drug registration result

Drug Administration of Vietnam shall notify the progress and result of online drug registration for each application when the applicant logs in the account for online drug registration. The result of online drug registration shall include these documents:

1) Notices of result

2) Decision on granting of registration number, attached list, samples of label and package insert/ product summary leaflet, license for sale of drug (to which a registration number has been affixed).

II. Implementation

1. Organizations are encouraged to register drugs online. During the pilot service, organizations may submit applications through either the paper-based system or the online system.

2. Applications lodged through the paper-based and online system shall be separately considered according to current regulations on drug registration. The written paper that indicates document verification result and registration number granted and bears electronic signature generated by the Government Cipher Committee shall have validity equal to similar document(s) given through the paper-based system.

3. Paper applications lodged before the existence of this guideline shall not be converted to electronic data until the pilot service ends.

4. Drug Administration of Vietnam shall cooperate with the software developer to generate guiding materials and video(s) for the use of the online public service of level 4. Guiding materials are available in the section "Hệ thống tiếp nhận và xử lý thủ tục đăng ký thuốc" (System for submission and processing of drug applications) on http://dav.gov.vn.

5. Drug Administration of Vietnam shall update and publish procedures for online submission and its processing of drug applications on http://dav.gov.vn.

Drug Administration of Vietnam delivers such information to applicants and producers for compliance. Difficulties shall be notified to the office of the Drug Administration (Tel: 04.37366483), the Drug Registration Division (Tel: 04. 37368258) or Viettel technicians (Duong Xuan Linh, Tel: 097.258.4868; Vu Thi Guong, Tel: 097.582.3927) for supports or reported in writing to the Drug Administration of Vietnam for timely solutions..

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This document is handled by Dữ Liệu Pháp Luật . Document reference purposes only. Any comments, please send to email: [email protected]