What are regulations on application form for extension of registration of traditional medicine in Vietnam?

What are regulations on application form for extension of registration of traditional medicine in Vietnam?

Pursuant to Form No. 04B of Appendix I promulgated together with the Circular 21/2018/TT-BYT stipulating application form for extension of registration of traditional medicine in Vietnam as follows:

APPLICATION FOR REGISTRATION OF TRADITIONAL MEDICINE

I. Information about registration and production facilities

1. Registrar (the establishment 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 representative office or contact person in Vietnam (if any):

Name:

Fixed phone:                                                              Mobile phone:

Contact address:

2. Production facility¹

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, processing method:

1.1. Name of the traditional medicine:

1.2. Processing method:

1.3. Registration number: issue date: expiration date:

2. Product Description :

2.1. Description of the processing method:

2.2. Description of packing:

2.3. Quality standards:

2.4. Due date:

2.5. Storage conditions:

3. Formula (including content of herbal ingredients and auxiliary materials) for the smallest dose unit or for the smallest packing unit

III. Documents attached to the provisions of this Circular, including:...

IV. Commitment of the registrar

The traditional medicine registration establishment commits to:

1. The actual traditional medicine has been circulated on the market.

2. In the course of circulation, the traditional medicine does not violate the regulations on registration and circulation of drugs and other provisions of law.

3. Checked and confirmed the above contents are true. The attached documents are in accordance with the documents submitted at the Administration of Traditional Medicine and Pharmacy. If there is a forgery or untruth, the registration establishment will take full responsibility and will be sanctioned according to the provisions of law.

4. Take full responsibility for intellectual property related to traditional medicine for registration.

__________________________

¹ The final manufacturer is responsible for the release of the product batch. In case 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 , ...

¹ If Pharmacopoeia standard, please specify under which version

What are regulations on application form for renewal of registration of medicinal herbs in Vietnam?

Pursuant to Form No. 04C of Appendix I promulgated together with the Circular 21/2018/TT-BYT stipulating application form for renewal of registration of medicinal herbs in Vietnam as follows:

APPLICATION FOR EXTENSION OF REGISTRATION OF MEDICINAL HERBS

I. 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 representative office or contact person in Vietnam (if any):

Name:

Fixed phone:                                                             Mobile phone:

Contact address:

2. Production facility¹

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 batch number of imported or manufactured medicinal herbs

III. Documents attached to the provisions of this Circular, including:...

IV. Commitment of the registrar

The traditional medicine registration establishment commits to:

1. Medicinal materials are actually circulated on the market.

2. In the course of circulation, herbal ingredients must not violate regulations on registration and circulation of drugs and other provisions of law.

3. Checked and confirmed the above contents are true. The attached documents are in accordance with the documents submitted at the Administration of Traditional Medicine and Pharmacy. If there is a forgery or untruth, the registration establishment will take full responsibility and will be sanctioned according to the provisions of law.

4. Take full responsibility for intellectual property related to herbal ingredients applied for registration.

__________________________

¹ The final manufacturer is responsible for the release of the product batch. In case 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 , ...

What are regulations on the application form for amendments or supplementations to the application for registration of traditional medicine (excluding traditional medicinal materials) in Vietnam?

Pursuant to Form No. 05A of Appendix I promulgated together with the Circular 21/2018/TT-BYT stipulating the application form for amendments or supplementations to the application for registration of traditional medicine (excluding traditional medicinal materials) as follows:

FORM 05A: APPLICATION FOR CHANGE AND ADDITION TO THE DOCUMENTS FOR REGISTRATION OF TRADITIONAL MEDICINE (EXCLUDING TRADITIONAL MEDICINAL MATERIALS)

I. 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 representative office or contact person in Vietnam (if any):

Name:

Fixed phone:                                                                  Mobile phone:

Contact address:

2. Manufacturing facility ¹

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, dosage form:

1.1. Tradenames:

1.2. Dosage forms:

1.3. Usage route:

1.4. Registration number: issue date: expiration date:

2. Product Description:

2.1. Description of dosage form:

2.2. Description of packing:

2.3. Quality standards:

2.4. Due date:

2.5. Storage conditions:

3. Formula (including content of herbal ingredients and excipients) for the smallest dose unit or for the smallest packing unit

III. Content, reason for change i

1. Changed content:

2. Reason for change:

IV. Attached technical documents ² :

1.

2.

V. Commitment of the registrar

The registration establishment undertakes to have checked, signed and stamped the relevant parts of all the papers submitted in this application and confirmed that these are legal documents and the contents are true. If there is a forgery or untruth, the registration establishment will take full responsibility and will be sanctioned according to the provisions of law.

__________________________

¹ The final manufacturer is responsible for the release of the product batch. In case 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 , ...

¹ If Pharmacopoeia standard, please specify under which version

² Technical documents corresponding to each changed content as prescribed in the Appendix to this Circular.

Best regards!