Official Dispatch 3682/QLD-DK 2023 receive online applications for certificates of free sale of drugs

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Official Dispatch No. 3682/QLD-DK dated April 13, 2023 of the Drug Administration of Vietnam regarding the implementation of the procedures for receiving applications for grant or renewal of certificates of free sale of drugs on the online public service system for drug registration

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Official number:	3682/QLD-DK	Signer:	Nguyen Thanh Lam
Type:	Official Dispatch	Expiry date:	Updating
Issuing date:	13/04/2023	Effect status:	Known Please log in to a subscriber account to use this function. Don’t have an account? Register here
Fields:	Food and drug , Medical - Health

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THE MINISTRY OF HEALTH

THE DRUG ADMINISTRATION OF VIETNAM

^________

No. 3682/QLD-DK

Regarding the implementation of the procedures for receiving applications for grant or renewal of certificates of free sale of drugs on the online public service system for drug registration

THE SOCIALIST REPUBLIC OF VIETNAM

Independence - Freedom - Happiness

^{______________}

Hanoi, April 13, 2023

To: Establishments registering or manufacturing drugs or drug materials

Pursuant to the Ministry of Health's Circular No. 08/2022/TT-BYT dated September 5, 2022, on marketing authorization of drugs and drug materials;

Pursuant to the Minister of Health's Decision No. 5480/QD-BYT dated December 23, 2015, on deploying the level-4 online public service on drug registration.

For further implementation of the Ministry of Health’s direction on the implementation of the online public service on drug registration, the Drug Administration of Vietnam has issued a notification on the implementation of procedures for receiving and handling applications for grant and renewal of certificates of free sale of drugs and drug materials as follows:

1. From May 4, 2023, the Drug Administration of Vietnam will receive applications for grant and renewal of certificates of free sale of drugs and drug materials (Procedures TT-89 and TT-90) only on the online public service system (including initial and additional applications); except for some parts of technical documents specified at Points a, b, c, Clause 2, Article 6 of Circular No. 08/2022/TT-BYT, that require the submission of paper copies at the same time as the online submission to facilitate the appraisal experts, including clinical and preclinical documents; bioequivalence research documents; GMP compliance assessment documents.

2. Establishments registering drugs and drug materials shall take full responsibility before the law for the accuracy, legality and truthfulness of all documents in drug registration applications submitted on the online public service system and be responsible for storing complete paper applications at the establishment for post-audit service.

3. Instructions for submission of applications are posted on the Drug Administration of Vietnam’s website as follows: The establishment logs into the account registered with the Drug Administration of Vietnam, sees the instructions in the section "Instructions for use" on the interface, and selects the procedure name for details.

4. In case of necessity due to difficulties and problems in submitting and processing online applications, the Drug Administration of Vietnam will send a written notice to enterprises to submit paper applications to ensure the processing time according to the regulations.

Any difficulties arising in the course of implementation should be reported to the Drug Administration of Vietnam (in writing), or an officer of the Drug Registration Office, for timely settlement. The officer's contact details: Phar. Ngo Dinh Nhan, Tel: 0782306244, email: [email protected].

The Drug Administration of Vietnam hereby informs establishments for implementation./.

For the Director General

The Deputy Director General

NGUYEN THANH LAM

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