What are regulations on the reporting form for the circulation of traditional drug/herbal material in Vietnam?

What are regulations on the reporting form for the circulation of traditional drug/herbal material in Vietnam?

Pursuant to Form 10 Appendix I of the Circular 21/2018/TT-BYT stipulating the reporting form for the circulation of traditional drug/herbal material in Vietnam as follows:

Traditional Drugs and Medicines Report

(From the time the registration certificate is granted to the time the registration certificate is renewed.)

1. Registered establishment name (address):

2. Manufacturer's name (address):

3. Name of the drug or medicinal ingredient that has been granted a registration certificate:

4. Dosage form or processing method:

5. Preparation recipe:

6. Registration certificate:                                          Date of issue:

7. Circulation on the market:

Yes No

8. Violation of quality:

Yes No

If yes, specify the content of the violation:

Number of violations:                      Type of violation:

9. Violations of regulations and rules governing drug or medicinal drug registration and the distribution of drugs or medicinal ingredients:

Yes □ No □

If there is a violation, specify the content of the violation.

Number of violations:                       Violating content:

10. Changes in the validity period of the registration certificate compared to the application already issued with the registration certificate:

Yes □ No □

If there are any changes, please attach a copy of the written permission.

11. Changes when renewing the registration certificate (the registration certificate has expired) compared to the application for which the registration certificate is granted:

Yes □ No □

If there is a change, it must clearly state the content of the change compared to the dossier already approved for the issuance of the registration certificate.

The registrar commits that, in addition to the contents requested to be changed in Section 8 of the report on the circulation of traditional drugs and medicinal herbs, there will not be any changes compared to the approved application for the Registration Certificate.

What are regulations on form for revocation of the certificate of traditional drug marketing authorization in Vietnam?

Pursuant to Form 11 Appendix I of the Circular 21/2018/TT-BYT stipulating the form for revocation of the certificate of traditional drug marketing authorization in Vietnam as follows:

Application for Recovery of Registration

Information about registration and production facilities

1. Registrar (the establishment that owns the circulation registration certificate)

1.1. Registrant Name:

1.2. Address:                                                                     Website (if any)

1.3. Phone number:                                                            Fax number:

Email:

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

Name:

Fixed phone; mobile phone:

Contact address:

^{2. Production} facility

2.1. Name of production facility

2.2. Address:                                                                       Website (if any)

2.3. Phone number:                                                               Fax number

Email:

2.4. Other production facilities:

II. Product details

1. Product name:

2. Registration certificate number; date of issue; expiration date:

3. Product Description:

3.1. Description of packing:

3.2. Quality standards:

3.3. Due date:

3.4. Storage conditions:

4. Report on the number of imported or manufactured traditional drugs or medicinal materials.

III. Reason for withdrawal:

IV. Commitment of the Registrar

The registrar commits to:

1. Traditional drugs/medicinal materials actually circulated on the market.

2. After the registration of circulation of traditional drugs/medicinal materials is revoked, the company will recall the products when circulating on the market.

3. verified that the above information is correct.The attached documents are in accordance with the documents submitted to the Administration of Traditional Medicine and Pharmacy. If a forgery or untruth is discovered, the registration establishment will accept full responsibility and be sanctioned in accordance with the law.

4. Take full responsibility for intellectual property related to traditional drugs and medicinal materials for registration.

_________________

^{1 The final manufacturer is in charge of the product batch's release.}In the case where the production facility is a registered establishment, it is not necessary to fill in the information.

^2: Specify the preparation phase: "research organization contract," "franchise, franchise,....

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

Pursuant to Article 18 of the Circular 21/2018/TT-BYT stipulating 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 revocation of the certificate of traditional drug marketing authorization in Vietnam? 

Pursuant to Article 33 of the Circular 21/2018/TT-BYT stipulating revocation of the certificate of traditional drug marketing authorization in Vietnam as follows:

Documents about revocation of certificates of traditional drug/herbal material marketing authorization include:

1. A copy of the decision on the recall of traditional drug/herbal material in the cases where the traditional drug/herbal material is recalled as prescribed in Points a and b Clause 1 Article 58 of the Law on Pharmacy.

2. A copy of the decision on the revocation of the certificate of pharmaceutical product that is revoked by a foreign competent authority in the cases where the traditional drug/herbal material is recalled as prescribed in Point c Clause 1 Article 58 of the Law on Pharmacy.

3. A certified true copy of the record of administrative violation against regulations on traditional drugs/herbal materials in the cases where the traditional drug/herbal material is recalled as prescribed in Points d and dd Clause 1 Article 58 of the Law on Pharmacy.

4. Originals of documents proving that the herbal material or traditional drug containing the herbal material that is not recommended by WHO or a Vietnamese competent authority or its country of origin in terms of safety and efficacy in the cases where the traditional drug/herbal material is recalled as prescribed in Point e Clause 1 Article 58 of the Law on Pharmacy.

5. An application form for revocation of the certificate of traditional drug/herbal material marketing authorization made by the manufacturer or the applicant using the Form No. 11 in the Appendix I hereof in the cases where the traditional drug/herbal material is recalled as prescribed in Point g Clause 1 Article 58 of the Law on Pharmacy.

Best regards!