Vietnam Cosmetics Regulations QA
Email: sgn4ww@evershinecpa.com
or
Contact us by WeChat or Skype or Whatsapp in the day-work-time of Vietnam (GMT+8)
The Engaging Manager from Headquarter
Ms. Judy Wang, CPA(Taiwan) Speaks in both English and Chinese.
WeChat: Judy_Evershine
skype: Judy Wang
HLF-TW-10
What are the categories of cosmetics in Vietnam? What is its official name?
What is the intensity of management of different categories? What is the governmental authority of cosmetics? Website?
Evershine RD:
In Vietnam, cosmetics are regulated by the Drug Administration of the Ministry of Health (DAV) under the Ministry of Health of Vietnam (MOH), which is responsible for receiving, processing applications and conducting post-market surveillance of marketed products. Vietnam Cosmetics Regulations follow the ASEAN Cosmetics Directive, and all cosmetic products need to be registered to be imported, distributed and sold anywhere in Vietnam.
ASEAN defines cosmetics as any substance or preparation intended to come into contact with the outside of the human body or the mucous membranes of the teeth and oral cavity to cleanse, fragrance, change the appearance and/or correct body odor and/or protect or maintain the health of the human body.
【參考連結】
https://dav.gov.vn/thu-tuc-hanh-chinh.html
HLF-TW-20
If a foreign company wants to sell cosmetics in Vietnam, no matter if it sets up a 100% subsidiary or branch, does it need to obtain an approval from local health bureau before the company’s registration? If so, what are the requests? What are the required documents and application procedures? Website?
Evershine RD:
No business license is required.
【參考連結】
https://dav.gov.vn/thu-tuc-hanh-chinh.html
HLF-TW-25
假如需要辦理,請問越南有專業服務公司可以協助辦理化妝品公司營業許可證?
Evershine RD:
無須申請營業特許證。
HLF-TW-30
If a foreign company wants to sell cosmetics in Vietnam, can it assign a Vietnam company to act as a business agent? What are the requests for acting as a business agent? What are the required documents and application procedures? What is the product liability of foreign companies and the business agents? Website?
Evershine RD:
Yes. Cosmetics must be sold with a cosmetic receipt number (product license), and registered in the name of a local company in Vietnam
In the authorization letter from the manufacturer or product owner authorizing the company responsible for introducing the product to the market or distributing cosmetics in Vietnam, for imported products, the authorization letter must be a notarized copy and be consularly authenticated as a legal requirement, but International treaties to which Vietnam is a party are exempt from consular authentication. The presentation language must be Vietnamese/English or bilingual Vietnamese and English, and must have sufficient of the following:
.Producer’s name and address
.The name and address of the authorized company
.Authorization scope
.Label or name of authorized product
.Authorization Term
.Product Information File (PIF)
.Name, title and signature of the principal’s representative
Cosmetics receipt number holders must comply with
1. Ensure that the technical and safety information of the product is readily available to the relevant regulatory agencies, and keep product distribution records for product recalls.
2. Notify the Authority of a fatal or life-threatening serious adverse event by telephone, fax, e-mail, or in writing as soon as possible, but no later than 7 calendar days after becoming known.
3. The product adverse reaction report (in the prescribed format) must be completed within 8 working days from the date of notification of the serious side effect mentioned in point 2 to the competent authority, and provide any information requested by the competent authority.
4. Immediately notify the competent authorities of any serious but not life-threatening or fatal side effects of the product.
5. Report all other non-fatal or life-threatening serious adverse events to the authorities as soon as possible using the Cosmetic Adverse Event Reporting Form, but no later than 15 calendar days after they become known.
6. It is the responsibility to ensure that the product information is correct and true, the responsibility to ensure that each batch of products meets all legal requirements, and to declare all the standards and specifications of the product to the authorities.
【參考連結】
https://dav.gov.vn/images/upload_file/2019/cong_bo_tthc_my_pham_1547118988.pdf
HLF-TW-35
假如需要辦理指派越南公司擔任營業代理人,請問越南有專業服務公司可以協助?
Evershine RD:
Nemos
http://nemosvietnam.com/en/index.php
Thorakao
HLF-TW-40
Do foreign companies need to apply for an approval before importing cosmetics sold to Vietnam? If yes, which authority is in charge? What documents are required? What is the application process? Do cosmetics packaging and labeling require prior approval?
Which languages are allowed? Website?
Evershine RD:
Yes. Cosmetics receipt numbers must be registered in the name of a local company in Vietnam.
Process
1. The local company responsible for bringing cosmetics to the market submits the application to the Vietnam Drug Administration (DAV) through the National Single Window webpage. (Each cosmetic needs to be applied separately)
2. DAV will receive the information within 1 working day from the date of receipt of the cosmetic application information.
3. Processing cosmetic application materials:
.DAV will issue a cosmetic receipt number within 3 working days of receipt of valid application materials and the stated fee.
.If the application materials do not meet the requirements, DAV shall electronically notify the applicant agency to revise and supplement the unqualified contents within 5 working days from the date of receipt of the application.
.Amendments and supplements to cosmetic application forms and/or other documents should be returned within 5 working days from the date of receipt of the requested supplementary documents.
.If the amended and supplemented dossier does not meet the requirements, DAV will notify in writing within 5 working days of receipt of the supplementary dossier that it does not agree to issue the cosmetic receipt number.
.If DAV does not receive the supplementary documents within 3 months from the date of sending the written notice of the amendments and supplementary materials, the application will be published and no longer valid. If a company wants to proceed with the application, they must submit a new application and pay the new fees/fees as required.
3. Submission of documents
.Cosmetic Declaration
.A letter of authorization from the manufacturer or product owner to authorize the company responsible for bringing the product to the market or to distribute cosmetics in Vietnam
.Certificate of Free Sale (CFS)
.Cosmetics Application Form
.Products comply with ASEAN Good Manufacturing Practice for Cosmetics or its equivalent
4. Contents of the cosmetic application form
.Product Details: List of brands, product names, shapes or colors
.Product type
.Expected usage
.Product introduction: single product/multiple colors/color chart in product type/combination product in single kit/other forms (please specify)
.Manufacturer/packer information (please include list if multiple): company name, type (primary/secondary), country, address, telephone, fax
.Manufacturer/assembler details (please include list if multiple): country, address, phone, fax
.Details of the local company responsible for placing the cosmetic product on the market: company name, address, telephone, fax, business license number, business registration number, person-in-charge details
.Importer details: company name, address, phone number, fax
.Complete list of ingredients (full 100% percentage, International Nomenclature of Cosmetic Ingredient)
.Declaration
5. In the authorization letter from the manufacturer or product owner authorizing the company responsible for introducing the product to the market or distributing cosmetics in Vietnam, for imported products, the authorization letter must be a notarized copy and be consularly authenticated as a legal requirement, but International treaties to which Vietnam is a party are exempt from consular authentication. The presentation language must be Vietnamese/English or bilingual Vietnamese and English, and must have sufficient of the following:
.Producer’s name and address
.The name and address of the authorized company
.Authorization scope
.Label or name of authorized product
.Authorization Term
.Product Information File (PIF)
.Name, title and signature of the principal’s representative
6. Certificate of Free Sale (CFS)
.The CFS issued in the current region must be original or legally notarized and still valid.
.If no expiry date is provided by CFS, it must be a certificate issued within 24 months.
.CFS must be consular legalized in accordance with the law, with the exception of consular legalization exemptions provided for by international treaties to which Vietnam is a party.
7. Product Information Document (PIF)
.PART 1: ADMINISTRATIVE DOCUMENTS AND PRODUCT SUMMARY
.Part 2: Ingredient Quality
.Part 3: Product Quality
.Part 4: Safety and Effectiveness
.PIFs, especially Part 1 documents, are required for inspection by the authorities. The rest of the PIF can be submitted within a maximum of 2 months.
8. Fee: VND 500,000 (per piece)
9. Requirements and conditions for the execution of administrative procedures (if any)
.The company responsible for placing the product in the market must have the function of trading cosmetics in Vietnam.
.Cosmetic property declarations (the intended use of the product) must comply with the ASEAN Guidelines for Cosmetic Property Declarations.
10. Validity period: Announcement card is valid for 5 years from the date of issuance
Label
According to the ASEAN Cosmetics Directive, the information that must be included on the packaging label of every cosmetic sold in Vietnam should include:
1. The name and function of the product, unless the presentation of the product already clearly shows the function of the product.
2. Directions for use.
3. All ingredients of the product formula must be clearly stated in accordance with the latest international nomenclature.
4. The country of origin of the manufactured product.
5. Weight and volume in English or SI units.
6. The name and description of the company responsible for the distribution and sale of the product. It should be stated in Vietnamese according to the business registration certificate.
7. Additional information on the label can be written in English or Vietnamese.
8. Production batch number.
9. The date of manufacture or expiry date must be clearly and accurately stated in the format DD/MM/YYYY or MM/YYYY. If necessary, instructions on product stability may be included.
10. For products with a shelf life of less than 30 months, the expiration date is mandatory and must be printed on the label.
11. Use safety warning statements.
12. All labels must be clearly printed on the package so that it is easily visible to consumers. Information must not be shielded or separated from the packaging of the cosmetic.
【參考連結】
https://dav.gov.vn/images/upload_file/2019/cong_bo_tthc_my_pham_1547118988.pdf
https://dav.gov.vn/van-ban-quan-ly/van-ban-phap-quy-vb40-page2.html
HLF-TW-45
請問在越南有哪些專業服務機構,可以協助辦理化妝品產品許可證?
Evershine RD:
Emerhub
Vietan Law
HLF-TW-50
Can a foreign company apply for a product license by its own name? If yes, which authority is in charge? What documents are required? What is the application process?
Do cosmetics packaging and labeling require prior approval? Which languages are allowed? Website?
Evershine RD:
Cosmetics receipt numbers must be registered in the name of a local company in Vietnam.
Process
1. The local company responsible for bringing cosmetics to the market submits the application to the Vietnam Drug Administration (DAV) through the National Single Window webpage. (Each cosmetic needs to be applied separately)
2. DAV will receive the information within 1 working day from the date of receipt of the cosmetic application information.
3. Processing cosmetic application materials:
.DAV will issue a cosmetic receipt number within 3 working days of receipt of valid application materials and the stated fee.
.If the application materials do not meet the requirements, DAV shall electronically notify the applicant agency to revise and supplement the unqualified contents within 5 working days from the date of receipt of the application.
.Amendments and supplements to cosmetic application forms and/or other documents should be returned within 5 working days from the date of receipt of the requested supplementary documents.
.If the amended and supplemented dossier does not meet the requirements, DAV will notify in writing within 5 working days of receipt of the supplementary dossier that it does not agree to issue the cosmetic receipt number.
.If DAV does not receive the supplementary documents within 3 months from the date of sending the written notice of the amendments and supplementary materials, the application will be published and no longer valid. If a company wants to proceed with the application, they must submit a new application and pay the new fees/fees as required.
3. Submission of documents
.Cosmetic Declaration
.A letter of authorization from the manufacturer or product owner to authorize the company responsible for bringing the product to the market or to distribute cosmetics in Vietnam
.Certificate of Free Sale (CFS)
.Cosmetics Application Form
.Products comply with ASEAN Good Manufacturing Practice for Cosmetics or its equivalent
4. Contents of the cosmetic application form
.Product Details: List of brands, product names, shapes or colors
.Product type
.Expected usage
.Product introduction: single product/multiple colors/color chart in product type/combination product in single kit/other forms (please specify)
.Manufacturer/packer information (please include list if multiple): company name, type (primary/secondary), country, address, telephone, fax
.Manufacturer/assembler details (please include list if multiple): country, address, phone, fax
.Details of the local company responsible for placing the cosmetic product on the market: company name, address, telephone, fax, business license number, business registration number, person-in-charge details
.Importer details: company name, address, phone number, fax
.Complete list of ingredients (full 100% percentage, International Nomenclature of Cosmetic Ingredient)
.Declaration
5. In the authorization letter from the manufacturer or product owner authorizing the company responsible for introducing the product to the market or distributing cosmetics in Vietnam, for imported products, the authorization letter must be a notarized copy and be consularly authenticated as a legal requirement, but International treaties to which Vietnam is a party are exempt from consular authentication. The presentation language must be Vietnamese/English or bilingual Vietnamese and English, and must have sufficient of the following:
.Producer’s name and address
.The name and address of the authorized company
.Authorization scope
.Label or name of authorized product
.Authorization Term
.Product Information File (PIF)
.Name, title and signature of the principal’s representative
6. Certificate of Free Sale (CFS)
.The CFS issued in the current region must be original or legally notarized and still valid.
.If no expiry date is provided by CFS, it must be a certificate issued within 24 months.
.CFS must be consular legalized in accordance with the law, with the exception of consular legalization exemptions provided for by international treaties to which Vietnam is a party.
7. Product Information Document (PIF)
.PART 1: ADMINISTRATIVE DOCUMENTS AND PRODUCT SUMMARY
.Part 2: Ingredient Quality
.Part 3: Product Quality
.Part 4: Safety and Effectiveness
.PIFs, especially Part 1 documents, are required for inspection by the authorities. The rest of the PIF can be submitted within a maximum of 2 months.
8. Fee: VND 500,000 (per piece)
9. Requirements and conditions for the execution of administrative procedures (if any)
.The company responsible for placing the product in the market must have the function of trading cosmetics in Vietnam.
.Cosmetic property declarations (the intended use of the product) must comply with the ASEAN Guidelines for Cosmetic Property Declarations.
10. Validity period: Announcement card is valid for 5 years from the date of issuance
Label
According to the ASEAN Cosmetics Directive, the information that must be included on the packaging label of every cosmetic sold in Vietnam should include:
1. The name and function of the product, unless the presentation of the product already clearly shows the function of the product.
2. Directions for use.
3. All ingredients of the product formula must be clearly stated in accordance with the latest international nomenclature.
4. The country of origin of the manufactured product.
5. Weight and volume in English or SI units.
6. The name and description of the company responsible for the distribution and sale of the product. It should be stated in Vietnamese according to the business registration certificate.
7. Additional information on the label can be written in English or Vietnamese.
8. Production batch number.
9. The date of manufacture or expiry date must be clearly and accurately stated in the format DD/MM/YYYY or MM/YYYY. If necessary, instructions on product stability may be included.
10. For products with a shelf life of less than 30 months, the expiration date is mandatory and must be printed on the label.
11. Use safety warning statements.
12. All labels must be clearly printed on the package so that it is easily visible to consumers. Information must not be shielded or separated from the packaging of the cosmetic.
【參考連結】
https://dav.gov.vn/images/upload_file/2019/cong_bo_tthc_my_pham_1547118988.pdf
https://dav.gov.vn/van-ban-quan-ly/van-ban-phap-quy-vb40-page2.html
HLF-TW-55
請問在越南有哪些專業服務機構,可以協助以外國公司名義辦理化妝品產品許可證?
Evershine RD:
Emerhub
Vietan Law
HLF-TW-60
What documents are required when importing approved cosmetics into Vietnam? What is the procedure?
Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?
Evershine RD:
After obtaining the receipt number of imported cosmetics, you can import cosmetics to Vietnam according to customs procedures.
Customs process
1. All goods imported into Vietnam must be declared and taxed unless the goods qualify for tax exemption or tax protection. Traders can submit the required information, electronic customs declarations through the National Single Window or the Vietnam Automated Customs Clearance System (VNACCS).
2. Importers are required to submit complete and correct electronic customs declarations and transport documents (such as bills of lading, etc.) through the VNACCS system within 30 days from the date of arrival.
3. Declaration and declaration submission
.Signed declaration form (original)
.Copy of business registration certificate
.Original power of attorney or notarized copy
.Certificate of Free Sale
.Commercial Invoice (copy)
.Sales contract (copy)
.Periodic Bill of Lading or Air Waybill
.List of goods (if any)
.Certificate of Origin (C/O)
.Receipt number for cosmetic
.Packing List
.Value statement (if any)
.Receipts (if any)
.Certificate of Origin (if any)
4. Pay taxes and fees as required and receive customs clearance information.
5. Contents of customs declaration
.Customs Registration and Customs Division
.Submission date and time
.Registration date and time
.Import port customs branch
.Number of declaration attachments
.Exporter, Type
.Commercial invoice
.Permit number
.Contract
.Importers
.Bill of Lading (No/Date)
.Port of Loading, Port of Unloading
.Trustee / Settlor
.Transportation
.Export country
.Customs declarer
.Arrival date
.Delivery terms
.Payment method, payment currency, tax rate
.Commodity description, product code, item, quantity, value, etc.
5. Storage
.If the importer does not plan to put the goods into Vietnam for circulation immediately, they can import into Vietnam according to the customs warehouse storage system. Tax protection is implemented when commodities are put into storage, and taxes are collected when commodities are put into circulation.
.Traders need to submit import declaration forms under the bonded warehousing system when they enter the warehouse, and they need to submit formal import declaration forms when goods enter circulation.
.There are various types of warehouses (bonded warehouses, deferred tax warehouses), and the goods brought into the warehouses must be approved by the General Administration of Customs of Vietnam or the Ministry of Finance.
No sales notification, but cosmetic advertisements on any of the following media: radio, TV, internet, newspapers, magazines, posters, events, etc. are regulated by Vietnamese law and must be approved before being displayed to the public.
The content of cosmetic advertisements must be appropriate and not misleading. It complies with the efficacy, safety and quality of the product as stipulated by the ASEAN Cosmetics Directive.
1. The applicant agency: The Drug Administration of Vietnam Ministry of Health (DAV)
2. Registration information
.Registration form: name, function and efficacy of cosmetic, applicant’s name, address, precautions for use, etc.
.Cosmetic receipt number copy (with company stamp of the product)
.A copy of the business registration certificate (with stamp)
.Power of Attorney (all company stamps for the product)
.Ad scenarios with clear descriptions of the music, images and content used
.Captioning material on product features and utility
【參考連結】
https://dav.gov.vn/dich-vu-cong-c5.html
https://www.customs.gov.vn/index.jsp?ngon_ngu=en
HLF-TW-70
What are the laboratory inspection materials that need to be attached for verification? Website?
Evershine RD:
The Product Information File (PIF) includes the following:
1. Administrative Documents and Product Summary
.A copy of the cosmetic bulletin with the national competent authority receipt number
.A letter of authorization from the manufacturer or product owner or a product-related agreement
.Certificate of Free Sale CFS (for imported foreign cosmetics)
.Other relevant administrative documents (business license or investment license of the enterprise responsible for bringing products to market)
.All ingredients and percentages in the recipe
.Labeling and Product Information
.User’s Manual (if available)
.Production announcement
.A declaration by the manufacturer that this product is manufactured in accordance with the principles and standards of the Association of Southeast Asian Nations (CGMP-ASEAN) Cosmetic Good Manufacturing Practice or equivalent
.Lot number/product code recording system
.Cosmetic Safety Assessment: Safety Statement (with signed conclusion, assessor name and certificate)
.Summary of whether, if any, harmful effects in humans
.Document (Summary) stating the properties and uses of the cosmetic product
.Reports evaluating product properties and uses based on ingredients and test results
2. Ingredient quality
.Quality standards and testing methods of raw materials, for fragrance ingredients, please indicate the name and number of the fragrance, the name and address of the supplier, and a commitment to comply with the guidelines of the International Fragrance Association (IFRA)
.Material safety data provided by suppliers based on published data or reports from scientific committees (ACSB, SCCP, CIR)
3. Product quality
.Product formula: full name of ingredients and percentage of ingredients in formula according to international nomenclature
.Manufacturer’s details: manufacturer’s country, name and address, packer
.More detailed information on the production process, quality control and related production records should be prepared as required by the governing body
.Finished product standards and test methods: microbial limit test standards, test methods corresponding to quality standards to check the pass level
.Product stability summary reports (for products with a shelf life of less than 30 months), stability study reports and data or stability assessments to explain the product’s shelf life
4. Safety and efficacy
.Safety Assessment: A report (with the assessor’s name and signature) evaluating the safety of the finished product to humans based on the ingredients in the formulation, the chemical structure of the ingredients, and hazard thresholds
.Product Safety Auditor Resume
.Regularly updated latest reports of side effects or adverse effects (if any)
.Documentation stating product characteristics and uses as published on product packaging: full report of product characteristics and use assessment based on ingredients and test results (with name and letter of auditor’s signature)
Sampling inspection of cosmetics after listing
The post-marketing inspection and sampling of cosmetics focuses on the following products:
1. Classification
.Skin whitening products
.Partial chromium (talc) or products containing minerals
.Products for eyes and lips
.Hair color products
.Products for children or pregnant women
2. Source
.Non-ASEAN countries
.Countries with a record of non-compliant products
3. Company, brand
.Violation record data
.Unidentified company
4. Ingredients
.Harmful substances containing heavy metals, asbestos and other toxic impurities
.Certain impermissible impurities such as TEA purity must be higher than 99% (maximum DEA content 0.5%) or impurities that may interact with other components such as nitrifying agents (nitrites in water)
5. Review criteria and ingredient focus
.Whitening products: mercury, hydroquinone, hormones (placenta extract)
.Baby Powder: Heavy Metals, Asbestos (Ammonia), Microbial Limits
.Eye makeup products: heavy metals, microbial limits
.Lip Products: Banned Colorants
.Hair Coloring Products: Banned Coloring Ingredients
.Plant material: plant protection substances, residues of microorganisms
6. Check the Product Information Summary (PIF) key points
.Product ingredients
.Production water standards
.Presence of benzene
.Dioxane content in ethoxylated materials such as SLES
.Mineral oil/Vaseline/Paraffin must meet COLIPA Distillation Guidelines
.Risk of nitrosamine contamination (nitrites in water may be a source of nitrifying agents)
7. Security assessment.
.Quality related factors such as document management, GMP declaration, cleanliness, hygiene during production
.Materials were obtained using biotechnology (be aware of the risk of genetic mutation)
.Plant extracts (note the solvents used, safety assessments, plant protectants, preservatives)
8. Test location: The Drug Administration (DAV) of the Ministry of Health lists the distribution channels, and the post-market inspection and supervision of cosmetics should be concentrated in the upstream (import, distribution, production key units) and can be inspected at the following locations:
.Cosmetics shop
.Shop in mall
.Pharmacy
.Salon
.Popular market
.Dermatology clinic etc.
9. The priority of post-market inspection of cosmetic products is based on product type, origin, brand, company brand and formulation ingredients
【參考連結】
https://dav.gov.vn/thu-tuc-hanh-chinh.html
HLF-TW-75
越南化妝品審核機構,能夠接受海外檢驗機構的檢驗資料嗎?假如是的話,有些被認可的機構?網頁?
Evershine RD:
SGS
STC
HLF-TW-77
請問在越南有哪些化妝品檢驗機構可以提供化妝品檢驗服務?網頁?
Evershine RD:
QIMA
SGS
HLF-TW-80
After a foreign subsidiary imports cosmetics and entrusts a distributor in Vietnam to sell it, does the distributor need a cosmetics business license? What are the respective responsibilities of foreign subsidiaries and distributors if cosmetic products have quality defects? Is it joint liability? Or can the responsibility of the foreign subsidiary be regulated?
Evershine RD:
No business license is required. Cosmetics must be sold with a cosmetic receipt number (product license).
Cosmetics receipt number holders must comply with
1. Ensure that the technical and safety information of the product is readily available to the relevant regulatory agencies, and keep product distribution records for product recalls.
2. Notify the Authority of a fatal or life-threatening serious adverse event by telephone, fax, e-mail, or in writing as soon as possible, but no later than 7 calendar days after becoming known.
3. The product adverse reaction report (in the prescribed format) must be completed within 8 working days from the date of notification of the serious side effect mentioned in point 2 to the competent authority, and provide any information requested by the competent authority.
4. Immediately notify the competent authorities of any serious but not life-threatening or fatal side effects of the product.
5. Report all other non-fatal or life-threatening serious adverse events to the authorities as soon as possible using the Cosmetic Adverse Event Reporting Form, but no later than 15 calendar days after they become known.
6. It is the responsibility to ensure that the product information is correct and true, the responsibility to ensure that each batch of products meets all legal requirements, and to declare all the standards and specifications of the product to the authorities.
【參考連結】
https://dav.gov.vn/images/upload_file/2019/cong_bo_tthc_my_pham_1547118988.pdf
HLF-TW-85
請問在越南有哪些專精於化妝品銷售與消費權益相關法律服務的業者?
Evershine RD:
IntracoLaw
ANT
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or
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or
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