|Issuing body:||Effective date:|
|Official number:||3683/QLD-DK||Signer:||Nguyen Thanh Lam|
|Type:||Official Dispatch||Expiry date:||Updating|
|Issuing date:||13/04/2023||Effect status:|
|Fields:||Food and drug Medical - Health|
THE MINISTRY OF HEALTH
THE DRUG ADMINISTRATION OF VIETNAM
Regarding the implementation of the procedures for receiving applications for change 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.
To implement the Ministry of Health’s direction on the implementation of the online public service on drug registration, the Drug Administration of Vietnam has issued notification on the implementation of procedures for receiving and handling applications for change of certificates of free sale of drugs and drug materials on the online public service system as follows:
- From April 20, 2023, the Drug Administration of Vietnam will pilot the receipt and processing of applications for change of certificates of free sale of drugs and drug materials (Procedure TT-91) on the online public service system concurrently with the receipt of paper applications at the Drug Administration of Vietnam for 1 month. After May 20, 2023, based on the actual situation of pilot implementation, the Drug Administration of Vietnam shall receive and process all applications on the online public service system.
- In order to integrate and update data of change applications in process or already processed on the online public service system, which have been submitted in paper form, the Drug Administration of Vietnam requests establishments to coordinate to:
- Update the information of the change applications submitted in paper form on the online public service system.
- Update official dispatches approved by the Drug Administration of Vietnam with changes during circulation on the online public service system.
Establishments are requested to complete the update of information within 60 days from the date of signing this official dispatch.
- The results of settling the procedures for changing the certificate of free shale (TT-91) shall be returned on the online public service system as follows:
- For minor changes only requiring notification: The settlement results shall be published on the website of the Drug Administration of Vietnam.
- For major changes and minor changes (except for changes specified at Point a, Section 3): The settlement results shall be electronically sent to the establishment's account registered with the Drug Administration of Vietnam and published on the website of the Drug Administration of Vietnam.
- 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.
- Instructions for submitting the applications for change of certificates of free sale of drugs and drug materials can be found in the Appendix to this official dispatch, and the guiding documents posted on the website of the Drug Administration of Vietnam: Establishments log into the accounts registered with the Drug Administration of Vietnam, see the instructions in the section "Instructions for use" on the interface, and select the procedure name for detailed instructions.
- 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 recommendations and contributions (if any) arising in the course of implementation should be sent to the Drug Administration of Vietnam (in writing), or reported to officer of the Drug Registration Office: Phar. Ngo Dinh Nhan, Tel: 0782306244, email: [email protected], for timely completing the software.
The Drug Administration of Vietnam hereby informs establishments for implementation./.
For the Director General
The Deputy Director General
NGUYEN THANH LAM
INSTRUCTIONS ON SUBMISSION AND RETURN OF THE RESULTS OF PROCESSING CHANGE APPLICATIONS ON THE ONLINE PUBLIC SERVICE SYSTEM
(Attached to Official Dispatch No. 3683/QLD-DK dated April 13, 2023, of the Drug Administration of Vietnam)
- Instructions for carrying out the procedure for changing certificates of free sale of drugs and drug materials - TT-91:
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 TT-91 for detailed instructions.
It is recommended to read carefully “Instructions for carrying out the procedure for changing certificates of free sale of drugs and drug materials” to make declarations and submit applications.
- For newly submitted applications:
The establishment logs in the online public service system at the address: https://dichvucong.dav.gov.vn.; clicks on tab “Register application” of the Procedure TT-91, selects “Add new application”, depends on the type of change or supplement to choose accordingly: Major change (MaV); Minor change requiring approval (MiV); Small change only requiring notification (MiV-N) (Note: when choosing the type of change: major change includes minor changes; if a minor change is chosen, major change cannot be added).
During the application declaration, there are a few things to keep in mind, as follows:
- In the Tab “Establishment information”: The establishment selects the name of the manufacturer, the name of the country of manufacture in accordance with the information of the changed drug.
- In the Tab “Changed information”:
It is recommended to fully declare the information and attached documents to be submitted in accordance with Appendix II of Circular No. 08/2022/TT-BYT, specifically as follows:
- Section “Information on type of application”: select the appropriate type of application: Domestic drugs mean domestically produced drugs; foreign drugs mean those manufactured in foreign countries.
- Section “Information on type of drug”: based on the type of drug to choose accordingly: pharmacochemical drugs, pharmaceutical materials, biological products, vaccines, antisera, drugs from medicinal materials, radioactive drugs.
- Section “Details of drug registration number”: press the button “Add drug” to declare information about the drug registration number of the change application; enter the registration information in the box “Registration number” by entering and selecting the registration number, continue to complete the required information marked with an asterisk (*).
If in the course of circulation, some administrative contents related to drug name, packing specification, drug quality standards, name and address of the establishment registering/manufacturing drugs have been approved, the establishment ticks in the box “Changed information in the course of circulation” and fill in the specific information that has been changed and supplemented accordingly, for example, if it is approved to change the name of the drug, the establishment fills in the changed drug name in the box “Drug name”.
When finishing filling in the information in the Tab “Registration details”, click the “Add registration number” button. In case of further revision of information in this section, click the blue button to fill in information.
- Section “Description of changes”: The establishment presses the “Add content” button, selects the item “Changes in Appendix II of the Circular”, if the changed content is not specified in Appendix II, then select the box “Other changes”.
+ Based on the changed content, select the changed application code to match the additional change in the box “Changed code (*)”, fill in the summary of the change corresponding to the selected one.
+ In case the changed content is related to information granted with a certificate of free sale, such as: Name of the drug, instructions for writing the dosage form, packing specifications, drug quality standards, shelf life, name, instructions for writing address of the establishment manufacturing or registering drugs; tick the box “Change information in the Decision on issuance of the registration number”, select the content to change, tick the box “Edit” and specify the reason. For example, if the change is about the drug name, then tick the box “edit” in the line of the drug name, select the box “Change” and fill in the information about the new drug name that is expected to be changed in the box “Information proposed for change”, after filling in all the information according to the instructions on the system, press the “Save” button to finish the declaration of changed content.
In case of further revision of information in this section, click the blue button to fill in information.
+ In case of adding changed contents, the establishment clicks the “Add content” button and declares the changed content according to the instructions on the System.
c) At the Tab “Attachment”:
- Depending on each type of application for domestic and foreign drugs, the establishment shall fully update the attached documents that are required to be submitted as prescribed in Appendix II of Circular No. 08/2022/TT-BYT in the “Attachment” Tab. The establishment downloads the attachments corresponding to each change according to the provisions of Appendix II of Circular No. 08/2022/TT-BYT which are suggested on the online system by clicking the button “Download file” , and enters the page number or summary name of the document, then click the “Attachment” button to upload the document to the System. In case this document has many pages or files, click “+ Add” to update more documents. Upon completing the update, click “Add file”.
- In addition to the required documents as prescribed in Appendix II of Circular No. 08/2022/TT-BYT, in order to ensure convenience for the review and appraisal of drug registration applications, the establishment may additionally update other documents related to the change application by clicking the “Add” button to update the document.
After uploading all required documents, press the “Save” button and tick the box “Establishment commits to satisfy the conditions (*)”, click the “Agree” button to complete the application preparation. The establishment may save the draft by clicking the “save draft” button to continue the process.
After saving the application (press the “save” button), the application is completed, the interface will return to “List of applications”.
* Signing and submitting the application online: Select the newly created dossier in the “List of applications” section to electronically sign and submit the application on the online system similar to procedures TT-90 and TT-89.
- For the applications for updating change applications in process that have been submitted in the paper form:
The establishment selects and clicks the tab “Register application” of Procedure TT-91, selects the section “UPDATE DOCUMENTS THAT HAVE BEEN SUBMITTED IN PAPER FORM” and declares drug information and attachments of the application for renewal of the certificate of free sale of drugs according to the instructions on the System. In the process of updating the application, there are a few things to keep in mind as follows:
a) At the “Changed information” tab:
The establishment is requested to update sufficient information (type of application; drug type; initially submitted application code; drug registration number; changed content) and attachments for the changed contents in accordance with the change application submitted in paper form at the Drug Administration of Vietnam similar to the instructions in Section 2.
b) At the Tab “Attachment”:
The establishment updates all documents and dossiers that have been initially and additionally submitted in paper form at the Drug Administration of Vietnam, name them according to the following syntax, for example: “LD - Document name” for the initial application, “BS1 - Document name” for the first additional application.
- Updating approved changes:
The establishment declares the changed contents at the tab “Changed information” and updates the official dispatch of the Drug Administration of Vietnam approving the changes at “Attachments" according to the instructions on the system as follows:
- The establishment separates the attachments and the official dispatch approving changes approved by the Drug Administration.
+ In the section “Approved official dispatch”, enter the number, approval date and summary of the official dispatch and update its Scan at the “Download file” button, for example: Official dispatch number xxxx/QLD-DK dated February 15, 2023, on changing the certificate of free sale.
+ In the Attachment section: The establishment updates the attached documents with the approved official dispatch of the Drug Administration of Vietnam and specifies the file name as: Attached to Official dispatch number xxxx/QLD-DK dated February 15, 2023, on changing the certificate of free sale. For documents that are samples of labels and/or instructions for drug use, it is recommended to separate these documents to update in a separate file.
- After finishing the update of attachments, the establishment clicks “Save” and digitally signs and submits the application similar to the online submission at TT-90, TT-89./.