What are regulations on sample authorization letter in name of the registration facility in request for certificate of traditional drug/herbal material marketing authorization in Vietnam?
What are regulations on sample authorization letter in name of the registration facility in request for certificate of traditional drug/herbal material marketing authorization in Vietnam? What are regulations on sample authorization letter to sign in a request for a certificate of traditional drug/herbal material marketing authorization in Vietnam? What are regulations on the sample authorization letter to use the name of a registered drug/medicinal ingredient in a request for a certificate of traditional drug/herbal material marketing authorization in Vietnam? What are regulations on submitting applications for registration of certificate of traditional drug/herbal material marketing authorization in Vietnam?
Please advise.
What are regulations on sample authorization letter in name of the registration facility in request for certificate of traditional drug/herbal material marketing authorization in Vietnam?
09A Appendix I issued with Circular 21/2018/TT-BYT regulates the form of authorization letter in the name of the registration facility in the request for registration of certificate of traditional drug/herbal material marketing authorization as follows:
AUTHORIZATION IN THE NAME OF THE REGISTRATION FACILITY
Title of the company (name, address of the authorized facility)
AUTHORIZATION LETTER
We, …………………………………………………………………………………………
(Name and address of product owner)
This document appoints……………………………………………………………………….
(Name and address of registered facility)
On our behalf, the establishment registers the following products:
Product's name:
Dosage form/processing method, content:
Number of issued Registration Certificate (for drugs/medicinal ingredients registered for renewal, registration of changes or supplements):
at the Ministry of Health (Department of Traditional Medicine and Pharmacy Administration)
The company (______) - the authorized facility - will be the owner of the circulation registration number and responsible to the Ministry of Health (Traditional Medicine and Pharmacy Administration) for all issues related to This product is in Vietnam.
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Director or legal representative of the authorized facility Signed (signed directly), stamped: Day month Year |
Director or legal representative of the authorized establishment Signed (signed directly), stamped: Day month Year |
What are regulations on sample authorization letter to sign in a request for a certificate of traditional drug/herbal material marketing authorization in Vietnam?
Form 09B Appendix I issued with Circular 21/2018/TT-BYT regulates the form of authorization letter to sign in the request for registration of certificate of traditional drug/herbal material marketing authorization as follows:
AUTHORIZATION TO SIGN ON DRUG/MEDICAL INGREDIENT REGISTRATION DOCUMENTS
Title of the company (name, address of the authorized facility)
AUTHORIZATION LETTER
We, ……………………………………………………………………………………
(Name and address of product owner/drug registration facility)
This document authorizes Mr./Ms. …….
Chief representative of the company's representative office in …………, Vietnam, on our behalf, signs and stamps the representative office's seal on the product documents:
Product's name:
Dosage form/processing method, content:
Number of issued Registration Certificate (for drugs/medicinal ingredients registered for renewal, registration of changes or supplements):
Registered at the Ministry of Health (Department of Traditional Medicine and Pharmacy Administration)
Validity period of authorization letter:
The person authorized to sign the application will be responsible to the Ministry of Health (Traditional Medicine and Pharmacy Administration) for all issues related to this product in Vietnam.
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Director or legal representative of the authorized facility Signed (signed directly), stamped: Day month Year |
Head of authorized representative office Signed (signed directly), stamped: Day month Year |
What are regulations on the sample authorization letter to use the name of a registered drug/medicinal ingredient in a request for a certificate of traditional drug/herbal material marketing authorization in Vietnam?
Form 09B Appendix I issued with Circular 21/2018/TT-BYT regulates the form of authorization letter to use the name of a registered drug/medicinal ingredient in the application for a drug circulation registration certificate, medicinal herbs are as follows:
AUTHORIZATION TO USE REGISTERED TRADEMARK NAME OF DRUG/MEDICAL INGREDIENT
(When the trademark owner is not the drug/medicinal registration facility)
Title of the company (name, address of the firm)
AUTHORIZATION LETTER
We, …………………………………………………………………………………
(Name and address of registered trademark owner - authorization basis)
I hereby agree to: ………………………………………………………….
(Name and address of authorized facility)
Copyright:
Validity period of authorization: this authorization is valid from .... to………
We commit that allowing the company (_________) to use the above registered trademark does not violate the legal intellectual property rights of any third party and commit to take full responsibility in case there was a dispute.
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Director or legal representative of the authorized facility Signed and sealed_________ Day month Year |
Director or legal representative of the authorized establishment Signed and sealed_________ Day month Year |
What are regulations on submitting applications for registration of certificate of traditional drug/herbal material marketing authorization in Vietnam?
Point b, Clause 5, Article 4, Circular 21/2018/TT-BYT amended by Clause 5, Article 1, Circular 39/2021/TT-BYT stipulating the submission of application dossiers for issuance of circulation registration certificates for drugs and pharmaceuticals whether in case of authorization is as follows:
5. Other documents:
a) The application form shall be signed by the head of the applicant or an authorized representative of the applicant and bear the seal (if any) of the applicant. Signature stamp must not be used;
b) In the case of authorization, the application shall include an original copy or certified true copy of the power of attorney issued by the applicant or representative office in Vietnam. To be specific:
- If the applicant authorized to apply for marketing authorization is not a manufacturer of traditional drug/herbal material and the foreign manufacturer of traditional drug/herbal material does not have a representative office in Vietnam, the power of attorney shall be prepared using the Form No. 09A enclosed with this Circular.
- If the representative office of the applicant for marketing authorization of traditional drug/herbal material is authorized to sign the marketing application, the power of attorney shall be prepared using the Form No. 09B enclosed with this Circular.
- If the brand owner that is not an applicant for marketing authorization of traditional drug/herbal material is authorized to use the name of the traditional drug/herbal material, the power of attorney shall be prepared using the Form No. 09C enclosed with this Circular.
c) If the registration establishment is not the manufacturer, the certificate of eligibility to trade herbal ingredients and traditional drugs of the registration establishment shall be a certified true copy or a copy certified with a seal of the manufacturer.
d) Certificates, protection certificates and contracts for assignment of industrial property rights in the application for drug marketing authorization (if any) that are granted or certified by industrial property authorities must be certified true copies or copies bearing stamp of the applicant.
Best regards!
