What are regulations on the product summary form to apply for a marketing registration certificate for traditional drugs (excluding prepared traditional medicinal materials) in Vietnam?
What are regulations on the product summary form to apply for a marketing registration certificate for traditional drugs (excluding prepared traditional medicinal materials) in Vietnam? What are regulations on the product summary form to apply for a marketing registration certificate for traditional medicines in Vietnam? What are regulations on product summary form to apply for circulation registration certificate for herbal ingredients in Vietnam? What are regulations on product summary form to request extension of marketing registration certificate for traditional drugs (excluding prepared traditional medicinal materials) in Vietnam? What are regulations on product summary form to request extension of circulation registration certificate for traditional medicine in Vietnam? What are regulations on product summary form to request extension of circulation registration certificate for herbal ingredients in Vietnam?
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What are regulations on the product summary form to apply for a marketing registration certificate for traditional drugs (excluding prepared traditional medicinal materials) in Vietnam?
Pursuant to Form 06A, Appendix I issued together with Circular 21/2018/TT-BYT stipulating the product summary form to apply for a marketing registration certificate for traditional drugs (excluding prepared traditional medicinal materials) in Vietnam as follows:
Summary of products requested for marketing registration certificates for traditional drugs
(excluding prepared traditional medicinal materials)
PRODUCT SUMMARY
|
Drug name: |
|
|
Dosage forms: |
|
|
Registrant Company Name: Address: Phone: Fax: |
Manufacturer's name (name of establishment in franchising and receiving franchise for drugs manufactured under franchise): Address: Phone: Fax: |
|
Name of the representative office in Vietnam (for foreign drugs) or the head office of the domestic drug registration company (if different from the registered company address) Address: Phone: Fax |
Name of packing establishment (if any): Address: Phone: Fax : |
|
Storage conditions: |
Due date: |
|
Usage route: |
Standard 1 |
Formulation (for a single dose unit or smallest packaging unit)
Ingredient:
|
Name of medicinal herbs, parts used |
Mass |
Manufacturer |
Standard 21 |
|
Excipients |
Content |
Manufacturer |
Standard 21 |
Packaging process:
__________________________
1 If it is a Pharmacopoeia standard, please specify the version
What are regulations on the product summary form to apply for a marketing registration certificate for traditional medicines in Vietnam?
Pursuant to Form 06B, Appendix I issued together with Circular 21/2018/TT-BYT stipulating the product summary form to apply for a marketing registration certificate for traditional medicines in Vietnam as follows:
Summary of products requested formarketing registration certificates for traditional medicines
PRODUCT SUMMARY
|
Name of traditional medicine: |
|
|
Processing method : |
|
|
Registrant Company Name: Address: Phone: Fax: |
Manufacturer's name (name of establishment in franchising and receiving franchise for drugs manufactured under franchise): Address: Phone: Fax: |
|
Name of the representative office in Vietnam (for foreign drugs) or the head office of the domestic drug registration company (if different from the registered company address) Address: Phone: Fax |
Name of packing establishment (if any): Address: Phone: Fax: |
|
Storage conditions: |
Due date: |
|
Standard 1 : |
|
Formulation (for a single dose unit or smallest packing unit)
Ingredient:
|
Name of medicinal herbs, parts used |
Mass |
Manufacturer |
Standard 2 2 |
|
Accessories |
Content |
Manufacturer |
Standard 2 2 |
Packaging process:
__________________________
1 If it is a Pharmacopoeia standard, please specify the version
What are regulations on product summary form to apply for marketing registration certificate for herbal ingredients in Vietnam?
Pursuant to Form 06C, Appendix I issued together with Circular 21/2018/TT-BYT stipulating the product summary form to apply for marketing registration certificate for herbal ingredients in Vietnam as follows:
Summary of products requested for marketing registration certificates for medicinal herbs
PRODUCT SUMMARY
|
Medicinal name: |
Parts used: |
|
Science name: |
|
|
Registrant Company Name: Address: Phone: Fax: |
Manufacturer's name (name of establishment in franchising and receiving franchise for drugs manufactured under franchise): Address: Phone: Fax: |
|
Name of the representative office in Vietnam (for foreign drugs) or the head office of the domestic drug registration company (if different from the registered company address) Address: Phone: Fax |
Name of packing facility (if any): Address: Phone: Fax: |
|
Storage conditions: |
Due date: |
|
Standard 1 : |
|
|
Packing methods: |
|
__________________________
1 If it is a Pharmacopoeia standard, please specify the version
What are regulations on product summary form to request extension of marketing registration certificate for traditional drugs (excluding prepared traditional medicinal materials) in Vietnam?
Pursuant to Form 07A, Appendix I issued together with Circular 21/2018/TT-BYT stipulating the product summary form to request extension of marketing registration certificate for traditional drugs (excluding prepared traditional medicinal materials) in Vietnam as follows:
Summary of products to request extension of marketing registration certificates for traditional drugs
(excluding prepared traditional medicinal materials)
PRODUCT SUMMARY
|
Drug name: |
|
|
Dosage forms: |
|
|
Registrant Company Name: Address: Phone: Fax: |
Name of manufacturer (name of establishment that franchises and receives franchise for drugs manufactured under franchise). Address: Phone: Fax: |
|
Name of the representative office in Vietnam (for foreign drugs) or the head office of the domestic drug registration company (if different from the registered company address) Address: Phone: Fax |
Name of packing facility (if any): Address: Phone: Fax : |
|
Storage conditions: |
Due date: |
|
Usage route: |
Standard 1 |
|
Certificate of marketing: Date of issuance of marketing registration certificate: First renewal : Second renewal : |
Registration expiration date: First renewal expiration date: Second renewal expiration date: |
Formulation (for a single dose unit or smallest packaging unit)
Ingredient:
|
Name of medicinal herbs, parts used |
Mass |
Manufacturer |
Standard 1 |
|
Excipients |
Content |
Manufacturer |
Standard 24 |
Packaging process:
_________________________
1 If it is a Pharmacopoeia standard, please specify the version
What are regulations on product summary form to request extension of circulation registration certificate for traditional medicine in Vietnam?
Pursuant to Form 07B, Appendix I issued together with Circular 21/2018/TT-BYT stipulating the product summary form to request extension of circulation registration certificate for traditional medicine in Vietnam as follows:
Summary of products to request extension of circulation registration certificates for traditional medicines
PRODUCT SUMMARY
|
Name of traditional medicine: |
|
|
Processing method: |
|
|
Registrant Company Name: Address: Phone: Fax: |
Name of manufacturer (name of establishment that franchises and receives franchise for drugs manufactured under franchise). Address: Phone: Fax: |
|
Name of the representative office in Vietnam (for foreign drugs) or the head office of the domestic drug registration company (if different from the registered company's address) Address: Phone: Fax |
Name of packing facility (if any): Address: Phone: Fax: |
|
Storage conditions: |
Due date: |
|
Standard 1 : |
|
|
Certificate of circulation registration: Date of issuance of circulation registration certificate: 1st renewal: 2nd renewal: |
Registration expiration date: 1st renewal expiration date: 2nd renewal expiration date: |
Formulation (for a single dose unit or smallest packing unit)
Ingredient:
|
Name of medicinal herbs, parts used |
Mass |
Manufacturer |
Standard 1 |
|
Accessories |
Content |
Manufacturer |
Standard 1 |
Packaging process:
_________________________
1 If it is a Pharmacopoeia standard, please specify the version
What are regulations on product summary form to request extension of circulation registration certificate for herbal ingredients in Vietnam?
Pursuant to Form 07C, Appendix I issued together with Circular 21/2018/TT-BYT stipulating the product summary form to request extension of circulation registration certificate for herbal ingredients in Vietnam as follows:
Summary of products to request extension of circulation registration certificates for herbal ingredients
PRODUCT SUMMARY
|
Medicinal name: |
|
|
Registrant Company Name: Address: Phone: Fax : |
Name of manufacturer (name of establishment that franchises and receives franchise for drugs manufactured under franchise). Address: Phone : Fax: |
|
Name of the representative office in Vietnam (for foreign drugs) or the head office of the domestic drug registration company (if different from the registered company's address) Address: Phone: Fax |
Name of packing establishment (if any) : Address: Phone: Fax: |
|
Storage conditions: |
Due date: |
|
Standard 1 : |
|
|
Certificate of circulation: Date of issuance of circulation registration certificate: 1st renewal: 2nd renewal: |
Registration expiration date: 1st renewal expiration date: 2nd renewal expiration date: |
Packaging process:
_________________________
1 If it is a Pharmacopoeia standard, please specify the version
Best regards!
