What are regulations on the application form for changes or additions to the application for registration of traditional medicines in Vietnam?

What are regulations on the application form for changes or additions to the application for registration of traditional medicines in Vietnam?

Pursuant to Form 05B, Appendix I issued together with Circular 21/2018/TT-BYT stipulating the application form for changes or additions to the application for registration of traditional medicines in Vietnam as follows:

APPLICATION FOR CHANGE AND ADDITION TO THE APPLICATION FOR REGISTRATION OF TRADITIONAL DRUGS

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, 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 medicinal herbs and ingredients ) for the smallest dosing unit or for the smallest packing unit

III . Content, reason for change

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 stage, “research organization contract”, franchise, etc.

¹ If it is a Pharmacopoeia standard, please specify which version

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

What are regulations on the application form for changes or additions to the application for registration of herbal ingredients in Vietnam?

Pursuant to Form 05C, Appendix I issued together with Circular 21/2018/TT-BYT stipulating the application form for changes or additions to the application for registration of herbal ingredients in Vietnam as follows:

APPLICATION FOR CHANGE AND ADDITION TO THE APPLICATION FOR REGISTRATION OF HERBAL INGREDIENTS

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:                issue date:                       expiration date:

3. Product Description:

3.1. Description of packing:

3.2. Quality standards:

3.3. Due date:

3.4. Storage conditions:

III. Content, reason for change

1. Changed content:

2. Reason for change:

IV. Technical documents attached ¹ :

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 stage, “research organization contract”, franchise, etc.

³ Technical documents corresponding to each changed content as prescribed in the Appendix to this Circular.

What are regulations on the application form for changes or additions to the application for registration of traditional drugs (excluding prepared traditional medicinal materials) in Vietnam?

Pursuant to Form 05A, Appendix I issued together with Circular 21/2018/TT-BYT stipulating the application form for changes or additions to the application for registration of traditional drugs (excluding prepared traditional medicinal materials) in Vietnam as follows:

APPLICATION FOR CHANGE AND ADDITION TO THE DOCUMENTS FOR REGISTRATION OF TRADITIONAL DRUGS (excluding prepared 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

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 stage, “research organization contract”, franchise, etc.

¹ If it is a Pharmacopoeia standard, please specify which version

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

Best regards!