Circular No. 54/2024/TT-BYT amends regulations on extending the registration certificates for traditional medicine drugs, traditional herbal medicines, and medicinal materials as stipulated in Circular No. 21/2018/TT-BYT issued by the Minister of Health regarding the registration of traditional medicine drugs and medicinal materials.

CIRCULAR

AMENDING AND SUPPLEMENTING CERTAIN PROVISIONS ON THE EXTENSION OF THE REGISTRATION LICENSE FOR TRADITIONAL MEDICINE DRUGS, TRADITIONAL MEDICINE INGREDIENTS, AND PHARMACEUTICAL MATERIALS IN CIRCULAR NO. 21/2018/TT-BYT DATED SEPTEMBER 12, 2018 ISSUED BY THE MINISTER OF HEALTH REGARDING THE REGISTRATION LICENSE FOR TRADITIONAL MEDICINE DRUGS AND PHARMACEUTICAL MATERIALS

BASED ON THE PHARMACEUTICAL LAW dated April 6, 2016;

Pursuant to the Law Amending and Supplementing Certain Provisions of the Medicine Law dated November 21, 2024;

Pursuant to Decree No. 54/2017/NĐ-CP dated May 8, 2017 of the Government detailing certain provisions and implementing measures of the Medicine Law;

Pursuant to the Decree No. 155/2018/NĐ-CP dated November 12, 2018 of the Government amending and supplementing certain regulations related to investment and business conditions within the scope of management of the Ministry of Health;

Pursuant to Decree No. 88/2023/NĐ-CP dated December 11, 2023 of the Government amending and supplementing certain provisions of Decree No. 54/2017/NĐ-CP dated May 8, 2017 of the Government detailing certain provisions and measures for implementing the Medicine Law and Decree No. 155/2018/NĐ-CP dated November 12, 2018 of the Government amending and supplementing certain related provisions concerning investment and business conditions within the scope of management of the Ministry of Health;

Pursuant to Decree No. 95/2022/NĐ-CP dated November 15, 2022 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

At the proposal of the Director of the Traditional Medicine Management Department;

The Minister of Health issues this Circular amending and supplementing certain provisions on the extension of the registration license for traditional medicine drugs, traditional medicine ingredients, and pharmaceutical materials in Circular No. 21/2018/TT-BYT dated September 12, 2018 issued by the Minister of Health regarding the registration license for traditional medicine drugs and pharmaceutical materials.

Article 1. Amending and supplementing certain provisions on the extension of the registration license for traditional medicine drugs, traditional medicine ingredients, and pharmaceutical materials in Circular No. 21/2018/TT-BYT dated September 12, 2018 issued by the Minister of Health regarding the registration license for traditional medicine drugs and pharmaceutical materials.

1. Amend Article 18 as follows:

"Article 18. Documents for requesting the extension of the registration license for traditional medicine drugs

1. Application form for extending the registration license for traditional medicine drugs according to Model No. 04A issued together with this Circular. In case there are changes in administrative information of the traditional medicine drug for which the extension of the registration license is requested, including name, address, registration entity; name, address of the production entity, the registration entity shall submit the application for change and supplementation according to Article 19 of this Circular. In case of a change in the name of the drug, the entity may implement it in the application for extension and clearly state it in the Application Form for Extending the Registration License for Traditional Medicine Drugs.

2. Certificate of pharmaceutical product validity for imported traditional medicine drugs.

3. Report on safety and efficacy of traditional medicine drugs during circulation according to Model No. 08C issued together with this Circular."

2. Amending and supplementing Article 21 as follows:

"Article 21. Procedures for extending the registration license for traditional medicine drugs

1. Within 12 months before the expiration of the registration license, the registration entity shall submit one set of documents for requesting the extension of the registration license for traditional medicine drugs (extension dossier) according to Article 18 of this Circular to the Department of Traditional Medicine and Pharmaceutical Administration, Ministry of Health through direct submission, postal service, or online submission via the Ministry of Health's online public service system. If the registration entity fails to submit the extension application dossier within the above period, the entity must follow the procedures for issuing a new registration license as stipulated in Article 20 of this Circular.

2. Upon receiving a complete extension dossier as prescribed, the Department of Traditional Medicine and Pharmaceutical Administration shall issue a receipt for the dossier to the registration entity according to Model No. 02A issued together with this Circular. In case the dossier is incomplete, the Department of Traditional Medicine and Pharmaceutical Administration shall notify the registration entity in writing or orally (if submitted directly) to supplement the dossier as required.

3. The registration license for traditional medicine drugs remains valid until extended or until the Department of Traditional Medicine and Pharmaceutical Administration issues a notice of non-extension or a notice to temporarily suspend the use of the registration license due to the discovery of potential risks to users or suspicion of falsified legal documents.

4. Extension of the registration license for traditional medicine drugs based on the review of the dossier and advice from the Council in the following cases:

a) Traditional medicine drugs as specified in Clause 1 and Clause 2 of Article 12 of this Circular;

b) Traditional medicine drugs that have quality violations at level 1 or level 2 as prescribed in Circular No. 38/2021/TT-BYT dated December 31, 2021 of the Minister of Health on the quality of traditional medicinal materials, traditional medicine ingredients, and traditional medicine drugs;

c) Traditional medicine drugs that have experienced serious adverse events during circulation reported in Model No. 08C issued together with this Circular.

5. Within a maximum period of three months from the date of receiving a complete dossier, the Department of Traditional Medicine and Pharmaceutical Administration shall issue a written approval or disapproval for the extension of the registration license for traditional medicine drugs for the cases specified in Clause 4 of this Article or traditional medicine drugs suspected of having falsified legal documents, specifically as follows:

a) Within seven days from the date of receiving a complete dossier, the Department of Traditional Medicine and Pharmaceutical Administration shall conduct a review and classification and send the dossier to experts or units for review. Within thirty days from the date of receiving the dossier from the Department of Traditional Medicine and Pharmaceutical Administration, the experts or units for review must complete the review report and send it back to the Department of Traditional Medicine and Pharmaceutical Administration for consolidation and conclusion;

b) Within twelve days from the date of receiving the Review Report, the Department of Traditional Medicine and Pharmaceutical Administration shall issue a written notification:

- Announcing the results of the review for dossiers requiring supplementation or not meeting requirements and specifying the reasons;

- Transferring the dossier to the Office of the Advisory Council for Issuing Drug Registration Licenses and Pharmaceutical Material Registration Licenses to organize a meeting of the Advisory Council for Issuing Drug Registration Licenses and Pharmaceutical Material Registration Licenses for dossiers that meet the criteria and those requiring opinions;

c) Within six working days from the date of receiving the documents from the Department of Traditional Medicine and Pharmaceutical Administration, the Office of the Advisory Council for Issuing Drug Registration Licenses and Pharmaceutical Material Registration Licenses shall organize a meeting of the Advisory Council for Issuing Drug Registration Licenses and Pharmaceutical Material Registration Licenses and send the minutes of the meeting back to the Department of Traditional Medicine and Pharmaceutical Administration.

d) Within eighteen days from the date of receiving the minutes of the advisory council meeting for issuing the drug registration certificate, the Traditional Medicine Management Department shall issue a document extending the drug registration certificate for traditional medicine or request modifications or supplements or refuse to issue the certificate according to the advisory council's proposal for issuing the drug registration certificate.

đ) The time period and number of times the registering entity modifies or supplements the dossier in accordance with Clause 9, Article 4 of this Circular.

6. Extend the drug registration certificate for traditional medicine without requiring a dossier review or advisory council consultation for cases not covered by Clause 5 of this Article.

Within three months from the date of receiving all documents, the Traditional Medicine Management Department shall issue a document agreeing or disagreeing to extend the drug registration certificate for traditional medicine, specifically as follows:

a) Within seven working days from the date of receiving all documents, the Traditional Medicine Management Department shall transfer the dossier to the experts or units for evaluation. Within thirty days from the date of receiving the dossier from the Traditional Medicine Management Department, the experts or units for evaluation must complete the evaluation report and submit it to the Traditional Medicine Management Department for consolidation and conclusion.

b) Within twelve days from the date of receiving the Review Report, the Department of Traditional Medicine and Pharmaceutical Administration shall issue a written notification:

- Notify the results of the evaluation for dossiers that require modification or supplementation or do not meet the requirements, specifying the reasons.

- Issue an extension of the drug registration certificate for traditional medicine for dossiers that meet the requirements.

c) The time period and number of times the registering entity modifies or supplements the dossier in accordance with Clause 9, Article 4 of this Circular.”

2. FOR NEWLY STARTED PROJECTS, IN ADDITION TO THE REQUIREMENTS SET OUT IN SUB-CLAUSE 1 OF THIS ARTICLE, THE FOLLOWING REQUIREMENTS MUST ALSO BE MET:

“Article 27. Dossier for Requesting Extension of Drug Registration Certificate for Traditional Medicine Ingredients.

Application for extension of the drug registration certificate for traditional medicine ingredients according to Form No. 04B or Application for extension of the drug registration certificate for medicinal materials according to Form No. 04C issued together with this Circular. In case there are changes in administrative information of the traditional medicine ingredients requesting an extension of the drug registration certificate including name, address, registering entity; name, address of the production entity, the registering entity shall submit a dossier for requesting changes or supplements in accordance with Article 28 of this Circular. In case the name of the traditional medicine ingredients changes, the entity may implement the change within the dossier for requesting an extension and clearly state it in the Application for extension of the drug registration certificate for traditional medicine ingredients.”

1. The Chief of the Customs Branch, the Chief of the Post-Customs Inspection Branch, the Team Leader of the Control Team under the Provincial Customs Department, the Team Leader of the Anti-Smuggling Control Team, the Team Leader of the Customs Procedure Team, the Squadron Leader of the Sea Control Squadron, and the Team Leader of the Intellectual Property Protection Control Team under the General Department of Customs Investigation and Smuggling Prevention have the authority:

“Article 30. Procedure for Extending the Drug Registration Certificate for Traditional Medicine Ingredients.

1. Within twelve months before the expiration of the drug registration certificate, the registering entity shall submit one set of dossier for requesting an extension of the drug registration certificate for traditional medicine ingredients (extension dossier) in accordance with Article 27 of this Circular to the Traditional Medicine Management Department under the Ministry of Health through direct submission or online submission on the online public service system. If the dossier for requesting an extension is not submitted within the above period, the entity must follow the procedure for issuing a new drug registration certificate as stipulated in Article 29 of this Circular.

2. Upon receiving a complete extension dossier as prescribed, the Department of Traditional Medicine and Pharmaceutical Administration shall issue a receipt for the dossier to the registration entity according to Model No. 02A issued together with this Circular. In case the dossier is incomplete, the Department of Traditional Medicine and Pharmaceutical Administration shall notify the registration entity in writing or orally (if submitted directly) to supplement the dossier as required.

3. The drug registration certificate for traditional medicine ingredients remains valid until extended or until the Traditional Medicine Management Department issues a notice refusing extension or temporarily suspends the use of the drug registration certificate due to the discovery of potential safety risks or suspicion of falsification of legal documents.

4. Extend the drug registration certificate for traditional medicine ingredients based on the evaluation of the dossier and advisory council consultation for cases where traditional medicine ingredients violate quality level 1 as defined in Circular No. 38/2021/TT-BYT dated December 31, 2021, issued by the Minister of Health regarding the quality of medicinal materials, traditional medicine ingredients, and traditional medicine.

5. Within a maximum of three months from the date of receiving all documents, the Traditional Medicine Management Department shall issue a document agreeing or disagreeing to extend the drug registration certificate for traditional medicine for cases specified in Clause 4 of this Article or traditional medicine ingredients suspected of falsifying legal documents. The procedures for extending the drug registration certificate for traditional medicine ingredients shall be carried out in accordance with Clause 5, Article 21 of this Circular.

6. Extend the drug registration certificate for traditional medicine ingredients without requiring a dossier evaluation or advisory council consultation for cases not covered by Clause 4 of this Article.

Within three months from the date of receiving all documents, the Traditional Medicine Management Department shall issue a document agreeing or disagreeing to extend the drug registration certificate for traditional medicine ingredients. The procedures for extending the drug registration certificate for traditional medicine ingredients shall be carried out in accordance with Clause 6, Article 21 of this Circular.”

5. Supplement Point c and Point d, Clause 1, Article 41 as follows:

“c) Within three working days from the date of receiving the dossier for requesting an extension of the drug registration certificate, the Traditional Medicine Management Department shall publicly announce the receipt of the dossier on the Ministry of Health’s electronic portal and the Traditional Medicine Management Department’s website;

d) Within three working days from the date the Traditional Medicine Management Department issues a notice refusing extension or temporarily suspending the use of the drug registration certificate due to the discovery of potential safety risks or suspicion of falsification of legal documents, the Traditional Medicine Management Department shall publicly announce the information on the Ministry of Health’s electronic portal and the Traditional Medicine Management Department’s website.”

6. Supplement Clause 4, Article 41 as follows:

“The National Center for Medicines Information and Adverse Drug Reaction Monitoring shall be responsible for compiling and reporting periodically every six months to the Traditional Medicine Management Department.”

Article 2. Effective Date

1. This Circular takes effect from January 1, 2025.

2. Clause 20 and Clause 27, Article 1 of Circular No. 39/2021/TT-BYT dated December 31, 2021, issued by the Minister of Health, amending and supplementing certain provisions of Circular No. 21/2018/TT-BYT dated September 12, 2018, concerning the registration of circulation of traditional medicine and medicinal materials become invalid from the date this Circular takes effect.

Article 3. Reference Provisions

In cases where referenced documents in this Circular are replaced or amended, they shall be implemented in accordance with the replaced or amended documents.

Article 4. Transitional Provisions

Applications for extending the drug registration certificate for traditional medicine, traditional herbal ingredients, and medicinal materials submitted before this Circular takes effect but have not yet been extended shall be handled as follows:

1\. May continue to use the drug registration certificate for traditional medicine, traditional herbal ingredients, and medicinal materials in accordance with point c, Clause 8, Article 56 of the Medicine Law amended by Clause 30, Article 1 of the Law Amending and Supplementing Certain Provisions of the Medicine Law.

2\. May continue to review and extend the Drug Registration Certificate if they comply with the provisions set out in Circular No. 21/2018/TT-BYT dated September 12, 2018, issued by the Minister of Health on the registration of traditional medicine and medicinal materials, and Circular No. 39/2021/TT-BYT dated December 31, 2021, issued by the Minister of Health amending and supplementing certain provisions of Circular No. 21/2018/TT-BYT dated September 12, 2018, on the registration of traditional medicine and medicinal materials. In cases where the entity requests handling under this Circular, it must complete the application dossier in accordance with the regulations to be considered for extension of the drug registration certificate.

Article 5. Responsibilities for Implementation

The Heads of the Ministry's Office; the Director of the Traditional Medicine and Pharmaceutical Administration Department; the Head of the Ministry's Inspectorate; the Heads of units under and affiliated with the Ministry of Health; Provincial Departments of Health under central cities and provinces; pharmaceutical business establishments; and related agencies, organizations, and individuals are responsible for implementing this Circular.

During implementation, if there are difficulties or obstacles, please report them to the Ministry of Health (Traditional Medicine and Pharmaceutical Administration Department) for consideration and resolution./.

ANNEX

(Attached to Circular No. Application form for extending the drug registration certificate for traditional medicine/traditional herbal ingredients/medicinal materials.

No.:    /PTN-YDCT-GH

1. Declaring entity:

Name of traditional medicine, traditional herbal ingredient, medicinal material

3\. The submitted dossier includes:

One original dossier, including:

Certificate of pharmaceutical product validity for imported traditional medicine.

1\. Registering entity (entity holding the drug registration certificate)

BM 04B

1.1\. Name of the registering entity:

1.2\. Address:                                                        Website

1.3\. Telephone number:                                              Fax number:

1.4\. Name and address of the representative office or contact person in Vietnam (if applicable):

Landline telephone:                                              Mobile phone: (if applicable):

Contact address:

Email:

2.1\. Name of the manufacturing entity:

Address:

2.2\. Address:                                                        Website

2.3\. Telephone number:                                               Fax number:

2. Production facility¹

2.4\. Other manufacturing entities:

Name and address (if applicable):

Role

Email:

II\. Product details:

1.2\. Proposed trade name change (if any):

1.3\. Dosage form:

1.4\. Route of administration:

1.5\. Registration certificate number:                  Date of issue:                    Expiry date:

2\. Product description:

2.1\. Description of dosage form:

2.2\. Packaging specifications:

2.3\. Quality standards:

2.4\. Shelf life:

2.5\. Storage conditions:

2.6\. Circulation status of the drug in Vietnam (tick the appropriate box):

□ Circulating

□ Not circulating.

3\. Formula (including herbal ingredient and excipient content) for the smallest unit dose or smallest packaging unit

Component

Herbal ingredient/excipient identification

Manufacturer (name, address)

Second renewal

5. Changes and supplements during the period when the registration certificate remains valid:

III. Summary Table of Information on Safety and Effectiveness Reporting During Circulation

IV. Commitment of the Registration Entity

The drug registration entity hereby commits:

1. The drug is actually circulating in the market.

2. During circulation, the drug does not violate pharmaceutical regulations.

3. The contents above have been verified and confirmed to be true. The accompanying documents match those previously submitted to the Traditional Medicine Management Department.

4. If there is any falsification or untruthfulness, the registration entity will bear full responsibility and will be punished according to the law.

5. Bear full responsibility for intellectual property rights related to the registered drug.

^{______________________________}

¹ The final manufacturer is responsible for releasing the batch product. In case the production entity is the registration entity, this information need not be filled out.

² Clearly state the processing steps, "research organization contract", licensing, etc.

³ If it is a Pharmacopoeia standard, please specify which version.

⁴ Attached documents

FORM NUMBER 04B

APPLICATION FOR EXTENSION OF TRADITIONAL MEDICINE REGISTRATION CERTIFICATE

1.2\. Address:                                                        Website

1.3\. Telephone number:                                              Fax number:

1.4\. Name and address of the representative office or contact person in Vietnam (if applicable):

1.2. Address:                                                         Website - Column (7): Land area in land allocation decisions, lease decisions, or documents of the competent authority or actual land area managed and used (applicable to assets that are buildings and land).

1.3. Phone number:                                      Fax number:

Email:

2.1\. Name of the manufacturing entity:

Address:

Landline:                                                          Mobile phone:

2.3\. Telephone number:                                               Fax number:

2. Production facility¹

2.1. Name of the manufacturing entity

2.2. Address:                                                          Website - Column (7): Land area in land allocation decisions, lease decisions, or documents of the competent authority or actual land area managed and used (applicable to assets that are buildings and land).

2.3. Phone number:                                                Fax number:

Email:

II\. Product details:

II. Product details

1. Product name, processing method:

1.1. Name of traditional medicine ingredient (already registered):

1.2. Name of traditional medicine ingredient (proposed change if applicable):

1.3. Preliminary processing and processing methods:

1.4. Registration certificate number:                            Date of issue:                   Expiry date:

2.3\. Quality standards:

2.1. Description of preliminary processing and processing methods:

2.5\. Storage conditions:

2.6\. Circulation status of the drug in Vietnam (tick the appropriate box):

□ Circulating

□ Not circulating.

2.6. Circulation status of traditional medicine ingredients in Vietnam (tick the appropriate box):

□ Traditional medicine ingredient is circulating.

□ Traditional medicine ingredient is not circulating.

3. Formula (including herbal and excipient quantities) for the smallest unit dose or smallest packaging unit

4. Registration and circulation status in Vietnam:

5. Changes and supplements during the period when the registration certificate remains valid:

III. Reports during circulation

1. Report on the quality status of traditional medicine ingredients during circulation:

2. Quantity of drugs produced and supplied to the market (by year):

IV. Commitment of the Registration Entity

The traditional medicine ingredient registration entity hereby commits:

1. The traditional medicine ingredient is actually circulating in the market.

2. During circulation, the traditional medicine ingredient does not violate registration and circulation regulations and other laws.

3. The contents above have been verified and confirmed to be true. The accompanying documents match those previously submitted to the Traditional Medicine Management Department.

4. If there is any falsification or untruthfulness, the registration entity will bear full responsibility and will be punished according to the law.

5. Bear full responsibility for intellectual property rights related to the registered traditional medicine ingredient.

^{_________________________________}

¹ The final manufacturer is responsible for releasing the batch product. In case the production entity is the registration entity, this information need not be filled out.

² Clearly state the processing steps, "research organization contract", licensing, etc.

³ If it is a Pharmacopoeia standard, please specify which version

BM 08A

APPLICATION FOR EXTENSION OF DRUG SUBSTANCE REGISTRATION CERTIFICATE

1.2\. Address:                                                        Website

1.3\. Telephone number:                                              Fax number:

1.4\. Name and address of the representative office or contact person in Vietnam (if applicable):

Landline telephone:                                              Mobile phone: (if applicable):

Contact address:

Email:

2.1\. Name of the manufacturing entity:

Address:

Landline:                                             Mobile phone:

2.3\. Telephone number:                                               Fax number:

2. Production facility¹

2.4\. Other manufacturing entities:

2.2. Address:                                                        Website (if applicable):

2.3. Phone number:                                              Fax number:

Email:

II\. Product details:

II. Product details

1. Product name, processing method:

1.1. Name of drug substance:

1.2. Preliminary processing and processing methods:

1.3. Registration number:                         Date of issue:                       Expiry date:

2.3\. Quality standards:

2.1. Description of preliminary processing and processing methods:

2.5\. Storage conditions:

2.6\. Circulation status of the drug in Vietnam (tick the appropriate box):

□ Circulating

□ Not circulating.

2.6. Circulation status of medicinal materials in Vietnam (tick X in the corresponding box):

□ Medicinal materials are circulating.

□ Medicinal materials are not circulating.

3. Formula for the smallest unit dose or for the smallest packaging unit

4. Registration and circulation status in Vietnam:

5. Changes and supplements during the period when the registration certificate remains valid:

III. Reports during circulation

1. Report on the quality status of medicinal materials during circulation:

2. Quantity of medicinal materials produced and supplied to the market (by year):

IV. Commitment of the Registration Entity

The registering entity of medicinal materials hereby commits:

1. The medicinal materials are actually circulating in the market.

2. During the circulation period, there has been no violation of regulations concerning drugs.

3. All contents have been verified and confirmed to be true.

4. The accompanying documents are consistent with those submitted to the Traditional Medicine Management Department. If there is any forgery or falsification, the registering entity will bear full responsibility and will be punished according to the law.

5. Full responsibility for intellectual property rights related to the registered medicinal materials.

^{_____________________________}

¹ The final manufacturer is responsible for releasing the batch product. In case the production entity is the registration entity, this information need not be filled out.

² Clearly state "research organization contract," licensing, etc.

³ If it is a Pharmacopoeia standard, please specify which version.

BM 08C

SAFETY AND EFFICACY REPORT OF TRADITIONAL MEDICINE

Respectfully submitted to: National Center for Drug Information and Adverse Reaction Monitoring

In accordance with the regulations on reporting safety and efficacy of traditional medicine during circulation and when applying for extension of registration for medicines requiring such reports, the entity … reports the following on the use of traditional medicine:

1. Name of the registering entity (address):

2. Name of the manufacturing entity (address):

3. Name of the medicine:

4. Formulation:

5. Formula, components:

6. Indications:

7. Route of administration:

8. Registration number:

Date of issuance of the registration certificate:

Expiry date of the registration certificate:

9. Summary table of adverse reaction reports of traditional medicine sent to the National Center for Drug Information and Adverse Reaction Monitoring related to unexpected effects of the drug after its release onto the Vietnamese market:

10. Summary table of the situation of medicine use at healthcare facilities nationwide, including:

- Information about healthcare facilities using the medicine (specify the name and address of each facility):

- Total quantity of medicine circulated:

11. Summary table of updates on safety and efficacy information implemented during circulation (updates approved by the Traditional Medicine Management Department; notifications; updates according to guidance letters from the Traditional Medicine Management Department if applicable).

12. Summary of clinical study results conducted in Vietnam (if any).

The registering entity commits that all reported contents are true; if not, the entity will fully bear responsibility./.

MODEL 08C

SAFETY AND EFFICACY REPORT OF TRADITIONAL MEDICINE DURING CIRCULATION

Respectfully submitted to:

1. General information:

1.1. Name of the registering entity                  Address:                               Telephone:

1.2. Name of the representative office in Vietnam (for foreign registering entities):

Address:                                          Telephone:

1.3. Name of the manufacturing entity:            Address:                                Telephone:

1.4. Name of the medicine:

1.5. Active ingredient, concentration/quantity:

1.6. Formulation:

1.7. Registration number:                Latest date of issuance/renewal:                   Expiry date:

2. Circulation status worldwide - Column (7): Land area in land allocation decisions, lease decisions, or documents of the competent authority or actual land area managed and used (applicable to assets that are buildings and land).

3. Report on the quality status of the medicine during circulation:

4. Changes related to drug safety information during the reporting period¹

5. Information on usage in the Vietnamese market

5.1. Quantity of medicine produced and supplied to the market (by year):

5.2. List of healthcare facilities using the medicine:

6. Summary of information on serious adverse events of traditional medicine recorded during circulation on the Vietnamese market:² Description of event

(tick √ for applicable content) □ The medicine does not have any quality issues or adverse events during circulation

□ There are records of quality violations and changes in the safety characteristics of the medicine compared to the approved product information leaflet

(specify the issue and measures taken to mitigate risks). 8. Conclusion and recommendations

The registering entity commits that all reported contents are true; if not, the entity will fully bear responsibility under the law./.

…., day…month…year….

^{______________________________}

¹ Provide a detailed description of the event or according to the MedDRA system (PT);

² Detailed description of the event or according to the MedDRA system (PT);