What are regulations on the report form for safety and effectiveness of traditional drugs/poisonous herbs of the registration establishment in Vietnam?

What are regulations on the report form for safety and effectiveness of traditional drugs/poisonous medicinal herbs of the registration establishment in Vietnam?

Pursuant to Form 08A, Appendix I issued together with Circular 21/2018/TT-BYT stipulating the report form for safety and effectiveness of traditional drugs/poisonous medicinal herbs of the registration establishment in Vietnam as follows:

REPORT ON SAFETY AND EFFECTIVE OF TRADITIONAL DRUGS/POISONOUS MEDICINAL HERBS

To: Ministry of Health (Department of Management of Traditional Medicine and Pharmacy)

Comply with regulations on reporting the safety and effectiveness of traditional drugs/poisonous medicinal herbs during circulation and upon registration renewal for traditional drugs that require reporting on safety and efficacy.
or toxic herbal ingredients, (name of the establishment) reports on the use of traditional drugs/poisonous medicinal herbs as follows:

1. Name of registered establishment (address):

2. Manufacturer's name (address):

3. Name of drugs/medicinal ingredients:

4. Dosage form ¹ :

5. Formula, ingredients ¹ :

6. Specify ¹ :

7. Route ¹ :

8. Registration Certificate No: Registration Certificate Date: Registration Expiry Date:

9. Summary of adverse drug reaction reports/poisonous medicinal herbs sent to ADR Centers and national drug information related to adverse drug effects after the drug is put on the market Vietnamese market (attach copies of reports according to the National Center for Drug Information and Adverse Drug Reactions Monitoring)

10. A summary of the use of toxic drugs/medicinal herbs at medical examination and treatment facilities nationwide (enclosed with a report certified by each medical examination and treatment facility, made according to form 08B) includes:

- Information about medical examination and treatment establishments that use toxic drugs/medicinal herbs (specify name and address of each facility):

- Total quantity of toxic drugs/medicinal ingredients used:

- Total number of patients who used toxic drugs/medicinal herbs:

- Used Time:

11. Summary table of updates on safety and efficacy of drugs/medicinal ingredients that have been made during circulation (updates approved by the Administration of Traditional Medicine and Pharmacy; updates with notification; updates according to the guiding documents of the Administration of Traditional Medicine and Pharmacy (if any).

12. Summary of results of clinical studies conducted in Vietnam (if any). The registration establishment commits that the reported contents are true, if not, the establishment will take full responsibility.

__________________________

¹ If it is a toxic medicinal material, it is not required to report this content.

What are regulations on the form of reporting on the use of traditional drugs/poisonous medicinal herbs in Vietnam?

Pursuant to Form 08B, Appendix I issued together with Circular 21/2018/TT-BYT stipulating the form of reporting on the use of traditional drugs/poisonous medicinal herbs in Vietnam as follows:

REPORT ON THE USE OF TRADITIONAL DRUGS/POISONOUS MEDICINAL HERBS

To: Ministry of Health (Department of Management of Traditional Medicine and Pharmacy)

Comply with regulations on reporting safety and effectiveness of toxic drugs/medicinal ingredients when re-registering for drugs that require reporting on safety, efficacy or toxic medicinal herbs, (name of the establishment) report The situation of using toxic drugs/medicinal herbs is as follows:

1. Name of drug/medicinal ingredient:

2. Registration No.:

3. Dosage form ¹ :

4. Medicinal materials, concentration/content ¹ :

5. Number of drugs/medicinal materials used:

6. Number of patients who used drugs/medicinal herbs:

7. Usage time:

8. Evaluation of safety and effectiveness of used drugs/medicinal herbs (with attached data).

9. Adverse drug/medicinal reactions (ADR): ADR manifestations, number of cases, results of ADR treatment (with attached data) .

10. Recommendations, suggestions (specify whether to continue using drugs/medicinal herbs at the treatment facility or not?).

(Treatment facility) commits and is responsible for the above report contents.

__________________________

¹ If it is a toxic medicinal material, it is not required to report this content.

What are regulations on the application for extension of the certificate of traditional drug marketing authorization in Vietnam?

Pursuant to Article 18 of the Circular 21/2018/TT-BYT stipulating the application for extension of the certificate of traditional drug marketing authorization in Vietnam as follows:

An application for extension of the certificate of traditional drug marketing authorization includes:

1. An application form (Form No. 04A or No. 04B in the Appendix I hereof).

2. Documents specified in Clauses 2 and 3 Article 16 of this Circular and documents specified in Clauses 6 and 7 Article 16 of this Circular if the traditional drug has its administrative documents changed on the extension date.

3. A report on sale of the traditional drug (Form No. 10 in the Appendix I hereof).

4. A report on safety and efficacy of the drug if its safety and efficacy still has to be monitored (Form No. 08 in the Appendix I hereof).

5. A copy of the issued certificate of drug marketing authorization in Vietnam.

What are regulations on the application for extension of the certificate of herbal material marketing authorization in Vietnam?

Pursuant to Article 27 of the Circular 21/2018/TT-BYT stipulating the application for extension of the certificate of herbal material marketing authorization in Vietnam as follows:

An application for extension of the certificate of herbal material marketing authorization includes:

1. An application form (Form No. 04C in the Appendix I hereof).

2. Documents specified in Clauses 2 and 3 Article 25 of this Circular and documents specified in Clauses 6 and 7 Article 25 of this Circular if the herbal material has its administrative documents changed on the extension date.

3. A report on sale of the herbal material (Form No. 10 in the Appendix I hereof).

4. A report on safety and efficacy of the herbal material on the list of toxic herbal materials promulgated by the Minister of Health (Form No. 08 in the Appendix I hereof).

5. A copy of the issued certificate of herbal material marketing authorization in Vietnam.

Best regards!