What are regulations on application form for registration of traditional medicinal materials in Vietnam?

What are regulations on application form for registration of traditional medicinal materials in Vietnam?

Pursuant to Form No. 03B of Appendix I promulgated together with the Circular 21/2018/TT-BYT stipulating application form for registration of traditional medicinal materials in Vietnam as follows:

APPLICATION FOR REGISTRATION OF TRADITIONAL MEDICINAL MATERIALS

1. Information about registration and production facilities

1. The registered establishment (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. Tradenames:

1.2. Processing method:

1.3. Registration certificate number ³ :                           issue date:                                  expiration date:

2. Product Description:

2.1. Description of packing:

2.2. Quality standards:

2.3. Due date:

2.4. Storage conditions:

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

III. Attached documents include:

1. Administrative records

2. Technical profile

3. Documents on intellectual property (if any)

IV. Commitment of the registrar

The drug registration establishment commits to:

1. Having checked, signed and stamped the relevant parts in all the papers submitted in the application for registration of this traditional medicine and confirmed that these are legal papers 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.

2. To ensure that the traditional medicine is produced in accordance with the dossier submitted for registration of the traditional medicine.

3. Notify and seek permission from the competent authority as prescribed when there is any change to the application for registration of a traditional medicine when the traditional medicine has been granted a circulation registration number.

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 , ...

³ It is only filled in in case of application for a certificate of circulation registration as prescribed at Point c, Clause 2, Article 55 of the Law on Pharmacy.

¹ If Pharmacopoeia standard, please specify under which version

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

Pursuant to Form No. 03C of Appendix I promulgated together with the Circular 21/2018/TT-BYT stipulating application form for registration of medicinal herbs in Vietnam as follows:

APPLICATION FOR 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. Product Description:

2.1. Description of packing:

2.2. Quality standards:

2.3. Due date:

2.4. Storage conditions:

2.5. Registration certificate number ³ :                         issue date:                              expiration date:

III. Attached documents include:

1. Administrative records

2. Technical profile

3. Documents on intellectual property (if any)

IV. Commitment of the registrar

The drug registration establishment commits to:

1. Having checked, signed and stamped the relevant parts in all the papers submitted in this application for registration of medicinal herbs and confirmed that these are legal papers, 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.

2. Ensure that herbal ingredients are manufactured in accordance with the submitted application for registration of herbal ingredients.

3. Notify and seek permission from the competent authority as prescribed when there are any changes to the application for registration of herbal ingredients when the herbal ingredient has been granted a circulation registration number.

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 , ...

³ It is only filled in in case of application for a certificate of circulation registration as prescribed at Point c, Clause 2, Article 55 of the Law on Pharmacy.

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

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

APPLICATION FOR EXTENSION OF 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. 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, 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 dosing unit or for the smallest packing unit

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

IV. Commitment of the registrar

The drug registration establishment commits to:

1. The drug is actually circulated on the market.

2. In the course of circulation, the drug 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 the drug 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 , ...

¹ If Pharmacopoeia standard, please specify under which version

Best regards!