越南化妆品登记法规问题集

Email：han4ww@evershinecpa.com
或
越南永辉BPO有限公司
联络人：苏 玉 燕 副总经理
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skype: rachelsu8
wechat: r0928486835
电话：+886-2-2717-0515 分机:104

各国化妆品登记法规问答集

HLF-VN-10
请问越南对于化妆品的归类方式为何？它的正式名称为何？
不同归类管理强度有何差异?它的政府管辖机构为何？网页？

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：

在越南，化妆品是由越南卫生部 (MOH)辖下的越南卫生部药品管理局(DAV)监管，DAV负责接受、处理申请并对已上市产品进行上市后监督。越南化妆品法规遵循东盟化妆品指令，所有化妆品都需要註册才能在越南任何地方进口、分销和销售。

东盟定义化妆品是任何旨在与人体外部或牙齿和口腔粘膜接触的物质或製剂，用以清洁、添香、改变外观和/或改善体臭和/或保护或维持 人体的健康状况。

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.

【参考连结】

https://dav.gov.vn/

https://dav.gov.vn/thu-tuc-hanh-chinh.html

HLF-VN-20
外国公司要到越南销售化妆品，无论设100%子公司或分公司，需要在公司登记时取得营业特许证？假如要，其必要条件是什麽？所需文件及申请程序为何？网页？

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：

无须申请营业特许证。

No business license is required.

【参考连结】

https://dav.gov.vn/thu-tuc-hanh-chinh.html

HLF-VN-25
假如需要办理，请问越南有专业服务公司可以协助办理化妆品公司营业许可证？

Evershine RD：

无须申请营业特许证。

HLF-VN-30
外国公司要到越南销售化妆品，可以指派越南公司担任营业代理人销售吗? 担任营业代理人，其必要条件是什麽？所需文件及申请程序为何？外国公司与营业代理人的产品责任为何?网页？

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：

可以，销售之化妆品须以越南当地公司名义申请化妆品收据编号 (产品许可证)。

 製造商或产品所有者授权负责将产品推向市场的公司或在越南分销化妆品的授权书当中，对于进口产品，授权书必须是经过公证的複印件，并作为法律规定进行领事认证，但越南加入的国际条约可免于领事认证。
呈现语言必须为越南语/英语或越南语和英语双语，并且提供以下内容：

．生产者的名称、地址

．授权公司的名称和地址

．授权范围

．授权产品的标籤或名称

．授权期限

．产品信息文件（PIF）

．委託方代表的姓名、职务和签名

化妆品收据编号持有公司必须遵守

1.确保产品的技术、安全信息随时可供相关监管机构使用，并保存产品分销记录以用于产品召回。

2. 通过电话、传真、电子邮件或书面形式尽快通知管理局致命或危及生命的严重不良事件，最晚不迟于获知后的 7 个日曆日。

3. 产品不良反应报告(按规定格式)必须在第2点所述严重副作用通知主管​​部门之日起 8 个工作日内完成，并提供主管部门要求的任何资料。

4. 立即通知主管当局产品的任何严重但不危及生命或致命的副作用。

5. 使用化妆品不良事件报告表尽快向当局报告所有其他非致命或危及生命的严重不良事件，不迟于知道后的 15 个日曆日。

6.有责任确保产品讯息正确、真实，有责任确保每批产品满足所有法律要求，并向当局申报产品的所有标准和规格。

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.

【参考连结】

https://dav.gov.vn/images/upload_file/2019/cong_bo_tthc_my_pham_1547118988.pdf

HLF-VN-35

HLF-VN-40
外国公司销售到越南化妆品本身，进口前需要办理产品许可吗？如需要，哪个单位在管理？
需要什麽文件？申请程序为何？化妆品包装内容及各种标示，需要事先核准吗？可允许的语文有哪些？网页？

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：

需要，须以越南当地公司名义註册化妆品收据编号(产品许可证)。

流程

1. 负责将化妆品推向市场的当地公司，通过国家单一窗口网页向越南药监局(DAV)提交申请。(每件化妆品需要单独申请)

2. 自收到化妆品申报资料之日起1个工作日内DAV将接收资料。

3.处理化妆品申请资料：

．DAV在收到有效的申请资料和规定的费用起3 个工作日内签发化妆品收据编号。

．如申请资料不符合要求，DAV应在收到申请日起5个工作日内以电子形式通知申请机构对不符合要求的内容进行修改和补充资料。

．化妆品申请单和/或其他文件的修改、补充应自收到要求补充文件日起5个工作日内回执。

．如果修改和补充的档案不符合要求，DAV将于收到补充档案之日起5个工作日内书面通知其不同意签发化妆品收据编号。

．发送需修改和补充资料的书面通知日起 3 个月内，如DAV未收到补充文件，则该申请将予以公佈不再有效。如果公司想要继续申请，他们必须提交新的申请并按规定支付新的费用/费用。

3.提交文件

．化妆品声明

．製造商或产品所有者授权负责将产品推向市场的公司或在越南分销化妆品的授权书

．自由销售证书 (CFS)

．化妆品申请表

．产品符合东盟规范之化妆品良好生产规范或等效标准

4.化妆品申请表内容

．产品详情：品牌、产品名称、形状或颜色列表

．产品类型

．预期用途

．产品介绍：单品/多种颜色/产品类型中的颜色表/ 单个套件中的组合产品/其他形式(请註明)

．生产商/包装商信息(如果有多个请附上清单)：公司名称、类型(初级包装/次级包装)、国家、地址、电话、传真

．製造商/装配商详情(如果有多个请附上清单)：国家、地址、电话、传真

．负责将化妆品投放市场的当地公司的详细信息：公司名称、地址、电话、传真、营业执照号码、商业登记号码、负责人资料

．进口商详情：公司名称、地址、电话、传真

．完整的成分清单(完整的 100% 百分比，国际化妆品成分命名法）

．声明

5. 製造商或产品所有者授权负责将产品推向市场的公司或在越南分销化妆品的授权书当中，对于进口产品，授权书必须是经过公证的複印件，并作为法律规定进行领事认证，但越南加入的国际条约可免于领事认证。
呈现语言必须为越南语/英语或越南语和英语双语，并且必须有足够的以下内容：

．生产者的名称、地址

．授权公司的名称和地址

．授权范围

．授权产品的标籤或名称

．授权期限

．产品信息文件（PIF）

．委託方代表的姓名、职务和签名

6. 自由销售证书（CFS）

．当前地区签发的CFS必须是原件或经过合法公证且仍在有效期内。

．如果 CFS 未提供到期日，则必须是24 个月内签发的证书。

．CFS必须根据法律规定进行领事合法化，但越南加入的国际条约规定的领事合法化豁免情况除外。

7. 产品信息文件（PIF）

．第 1 部分：行政文件和产品摘要

．第 2 部分：成分质量

．第 3 部分：产品质量

．第 4 部分：安全性和有效性

．当局检查时需要提交 PIF，尤其是第 1 部分文件。 PIF 的其他部分最多可在 2 个月内提交。

8.费用：500,000 越南盾(每件)

9.执行行政程序的要求和条件(如有)

．负责将产品在市场上流通的公司和必须具有在越南交易化妆品的功能。

．化妆品特性声明(产品的预期用途)必须符合东盟化妆品性能声明指南。

10.效期：公告卡自签发之日起5年内有效

标籤

根据东盟化妆品指令，在越南销售的每种化妆品的包装标籤上必须包含的信息应包括：

1.产品的名称和功能，除非产品的呈现形式已经清楚地显示了产品的功能。

2.使用说明。

3.产品配方的全部成分，所有成分必须按照最新的国际命名法明确说明。

4.製造产品的原产国。

5.英製或国际单位制的重量和体积。

6.负责分销和销售产品的公司名称、说明。应根据商业登记证以越南文註明。

7.标籤上的其他信息可以用英语或越南语书写。

8.生产批号。

9.必须以 DD/MM/YYYY 或 MM/YYYY 的格式清楚准确地说明生产日期或到期日期。如有必要，可包含有关产品稳定性的说明。

10.对于保质期少于30个月的产品，有效期是强制性的，并且必须印在标籤上。

11.使用安全的警告声明。

12.所有标籤必须清楚地印在包装上，以便消费者很容易看到。信息不得从化妆品的包装中屏蔽或分离。

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.

【参考连结】

http://vnsw.gov.vn

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-VN-45

HLF-VN-50
外国公司可以用自己名义申请办理产品许可吗？如需要，哪个单位在管理？需要什麽文件？申请程序为何？
化妆品包装内容及各种标示，需要事先核准吗？可允许的语文有哪些？？网页？

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：

须以越南当地公司名义註册化妆品收据编号(产品许可证)。

流程

1. 负责将化妆品推向市场的当地公司，通过国家单一窗口网页向越南药监局(DAV)提交申请。(每件化妆品需要单独申请)

2. 自收到化妆品申报资料之日起1个工作日内DAV将接收资料。

3.处理化妆品申请资料：

．DAV在收到有效的申请资料和规定的费用起3 个工作日内签发化妆品收据编号。

．如申请资料不符合要求，DAV应在收到申请日起5个工作日内以电子形式通知申请机构对不符合要求的内容进行修改和补充资料。

．化妆品申请单和/或其他文件的修改、补充应自收到要求补充文件日起5个工作日内回执。

．如果修改和补充的档案不符合要求，DAV将于收到补充档案之日起5个工作日内书面通知其不同意签发化妆品收据编号。

．发送需修改和补充资料的书面通知日起 3 个月内，如DAV未收到补充文件，则该申请将予以公佈不再有效。如果公司想要继续申请，他们必须提交新的申请并按规定支付新的费用/费用。

3.提交文件

．化妆品声明

．製造商或产品所有者授权负责将产品推向市场的公司或在越南分销化妆品的授权书

．自由销售证书 (CFS)

．化妆品申请表

．产品符合东盟规范之化妆品良好生产规范或等效标准

4.化妆品申请表内容

．产品详情：品牌、产品名称、形状或颜色列表

．产品类型

．预期用途

．产品介绍：单品/多种颜色/产品类型中的颜色表/ 单个套件中的组合产品/其他形式(请註明)

．生产商/包装商信息(如果有多个请附上清单)：公司名称、类型(初级包装/次级包装)、国家、地址、电话、传真

．製造商/装配商详情(如果有多个请附上清单)：国家、地址、电话、传真

．负责将化妆品投放市场的当地公司的详细信息：公司名称、地址、电话、传真、营业执照号码、商业登记号码、负责人资料

．进口商详情：公司名称、地址、电话、传真

．完整的成分清单(完整的 100% 百分比，国际化妆品成分命名法）

．声明

5. 製造商或产品所有者授权负责将产品推向市场的公司或在越南分销化妆品的授权书当中，对于进口产品，授权书必须是经过公证的複印件，并作为法律规定进行领事认证，但越南加入的国际条约可免于领事认证。
呈现语言必须为越南语/英语或越南语和英语双语，并且必须有足够的以下内容：

．生产者的名称、地址

．授权公司的名称和地址

．授权范围

．授权产品的标籤或名称

．授权期限

．产品信息文件（PIF）

．委託方代表的姓名、职务和签名

6. 自由销售证书（CFS）

．当前地区签发的CFS必须是原件或经过合法公证且仍在有效期内。

．如果 CFS 未提供到期日，则必须是24 个月内签发的证书。

．CFS必须根据法律规定进行领事合法化，但越南加入的国际条约规定的领事合法化豁免情况除外。

7. 产品信息文件（PIF）

．第 1 部分：行政文件和产品摘要

．第 2 部分：成分质量

．第 3 部分：产品质量

．第 4 部分：安全性和有效性

．当局检查时需要提交 PIF，尤其是第 1 部分文件。 PIF 的其他部分最多可在 2 个月内提交。

8.费用：500,000 越南盾(每件)

9.执行行政程序的要求和条件(如有)

．负责将产品在市场上流通的公司和必须具有在越南交易化妆品的功能。

．化妆品特性声明(产品的预期用途)必须符合东盟化妆品性能声明指南。

10.效期：公告卡自签发之日起5年内有效

标籤

根据东盟化妆品指令，在越南销售的每种化妆品的包装标籤上必须包含的信息应包括：

1.产品的名称和功能，除非产品的呈现形式已经清楚地显示了产品的功能。

2.使用说明。

3.产品配方的全部成分，所有成分必须按照最新的国际命名法明确说明。

4.製造产品的原产国。

5.英製或国际单位制的重量和体积。

6.负责分销和销售产品的公司名称、说明。应根据商业登记证以越南文註明。

7.标籤上的其他信息可以用英语或越南语书写。

8.生产批号。

9.必须以 DD/MM/YYYY 或 MM/YYYY 的格式清楚准确地说明生产日期或到期日期。如有必要，可包含有关产品稳定性的说明。

10.对于保质期少于30个月的产品，有效期是强制性的，并且必须印在标籤上。

11.使用安全的警告声明。

12.所有标籤必须清楚地印在包装上，以便消费者很容易看到。信息不得从化妆品的包装中屏蔽或分离。

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.

【参考连结】

http://vnsw.gov.vn

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-VN-55

HLF-VN-60
经过核准登记的化妆品，进口到越南要检附什麽文件？经过什麽手续？
在销售时要向各地的卫生福利部相关机构事先或事后准备吗？网页？

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：

取得进口化妆品的收据编号后可以依据海关流程进口化妆品至越南。

海关流程

1.所有进口到越南的货物都必须申报并徵税，除非货物符合免税或税收保护的条件。贸易商可通过国家单一窗口或越南自动清关系统 (VNACCS) 提交所需信息、电子报关单。

2.进口商需自到货之日起30日内通过VNACCS系统提交完整无误的电子报关单、运输单证信息（如提单等）。

3. 申报报关提交文件

．已签署的报关单（原件）

．商业登记证複印件

．授权书原件或公证副本

．免费销售证书

．商业发票（複印件）

．销售合同（複印件）

．定期提单或空运提单

．货物清单（如有）

．原产地证书（C/O）

．化妆品的收据编号

．装箱单

．价值声明（如有）

．收据（如有）

．原产地证书（如有）

4. 按规定缴纳税费，接收清关信息。

5.报关单内容

．报关登记海关分部

．提交日期和时间

．註册日期和时间

．进口口岸海关分局

．申报附件数量

．出口商、类型

．商业发票

．许可证号

．合同

．进口商

．提单（编号/日期）

．装货港、卸货港

．受託人/委託人

．运输工具

．出口国

．报关员

．到货日期

．交货条件

．付款方式、支付货币、税率

．商品说明、产品代码、项目、数量、价值等

5.仓储

．如果进口商不打算立即将货物投入越南流通，可以根据海关仓库储存制度进口到越南。商品入库时实行税收保护，商品投入流通时才徵收税款。

．贸易商在入库时需要提交保税仓储制度下的进口报关单，在货物进入流通时需要提交正规的进口报关单。

．仓库有多种类型（保税仓库、暂缓税仓库），带入仓库的货物必须得到越南海关总署或财政部的批准。

无销售通知，但在以下任何媒体上的化妆品广告：广播、电视、互联网、报纸、杂誌、海报、活动等均受越南法律监管，并且必须在向公众展示之前须获得批准。化妆品广告的内容必须恰当，不得误导。它符合东盟化妆品指令规定的产品的有效性、安全性和质量。

1.申请机构：越南卫生部药品管理局(DAV)

2.登记资料

．登记表：化妆品的名称、功能和功效、申请人的姓名、地址、使用注意事项等

．化妆品收据编号副本(产品所有公司盖章)

．商业登记证副本(加盖印章)

．授权书(产品所有公司盖章)

．对所使用的音乐、图片和内容进行清晰描述的广告场景

．产品特性和效用的字幕材料

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

【参考连结】

https://www.vietnamtradeportal.gov.vn/index.php?r=site/display&id=795#Gi%E1%BA%A5y%20ph%C3%A9p%20nh%E1%BA%ADp%20kh%E1%BA%A9u

https://dav.gov.vn/dich-vu-cong-c5.html

https://www.customs.gov.vn/index.jsp?ngon_ngu=en

HLF-VN-70
越南化妆品审核机构，需要附上的实验室检验资料有哪些? 网页？

What are the laboratory inspection materials that need to be attached for verification? Website?

Evershine RD：

产品信息文件（PIF）包括以下内容：

1. 行政文件和产品概要

．带有国家主管部门收据编号的化妆品公告单複印件

．製造商或产品所有者的授权书或与产品相关的协议书

．自由销售证明  CFS（针对进口外国化妆品）

．其他相关行政文件（负责将产品推向市场的企业营业执照或投资许可证）

．配方中所有成分和百分比

．标籤和产品信息

．用户手册（如果有）

．生产公告

．製造商声明该产品是按照东南亚国家联盟 (CGMP-ASEAN) 的化妆品良好生产规范或同等标准的原则和标准製造的

．批号/产品代码记录系统

．化妆品安全性评估：安全声明（带有签名的结论、评估者姓名和证书）

．对人类是否有害影响的总结（如果有的话）

．说明化妆品特性和用途的文件（概要）

．根据成分和测试结果评估产品特性和用途的报告

2. 成分质量

．原材料的质量标准和检测方法，对于香精成分，请註明香精的名称和编号、供应商的名称和地址，并承诺遵守国际香精协会 (IFRA) 的指导方针

．供应商提供之材料安全数据，须根据已发布的数据或科学委员会（ACSB、SCCP、CIR）的报告

3. 产品质量

．产品配方：根据国际命名法成分的全称和配方中成分的百分比

．製造商的详细信息：製造商的国家、名称和地址、包装商

．生产过程、质量控制和相关生产记录的更详细信息，应根据管理机构的要求准备

．成品标准及测试方法：微生物限度测试标准、与质量标准相对应的测试方法来检查通过水平

．产品稳定性总结报告（对于保质期少于 30 个月的产品）、稳定性研究报告和数据或稳定性评估来解释产品的保质期

4. 安全性和有效性

．安全评估：根据配方中的成分、成分的化学结构和危害阈值评估成品对人体安全的报告（带有评估者的姓名和签名）

．产品安全审核员的简历

．定期更新的副作用或不良影响（如果有）的最新报告

．说明产品包装上公佈的产品特性和用途的文件：基于成分和测试结果（带有姓名和字母）审核员签名的产品特性和用途评估的完整报告）

化妆品上市后抽检

化妆品上市后检验抽样重点关注以下产品：

1.分类

．皮肤美白产品

．部分铬（滑石粉）或含有矿物质的产品

．眼睛和嘴唇的产品

．染发产品

．供儿童或孕妇使用的产品

2.来源

．非东盟国家

．有不合规产品纪录的国家

3. 公司、品牌

．违规纪录数据

．鲜为人知、不知名的公司

4.成分

．含有重金属、石棉等有毒杂质的有害物质

．某些不允许的杂质，例如 TEA 纯度必须高于 99%（最大 DEA 含量 0.5%）或可能与其他成分相互作用的杂质，如硝化剂（水中的亚硝酸盐）

5. 审查标准和成分重点

．美白产品：汞、对苯二酚、激素（胎盘提取物）

．婴儿爽身粉：重金属、石棉（氨）、微生物限度

．眼妆产品：重金属、微生物限度

．唇部产品：禁用着色剂

．染发产品：禁用的染色成分

．植物材料：植物保护物质、微生物的残留物

6. 检查产品信息概要 (PIF)注意重点

．产品配方

．生产用水标准

．苯的存在

．乙氧基化材料中的二噁烷含量，例如 SLES

．矿物油/凡士林/石蜡必须符合 COLIPA 蒸馏指南的要求

．亚硝胺汙染风险（水中的亚硝酸盐可能是硝化剂的来源）

7.安全评估。

．与质量相关的因素，如文件管理、GMP 声明、清洁度、生产过程中的卫生

．材料是使用生物技术获得的（注意基因突变的风险）

．植物提取物（注意使用的溶剂、安全评估、植物保护剂、防腐剂）

8. 测试地点：卫生部药品管理局(DAV) 列出分销渠道，化妆品上市后检验监管需集中在上游（进口、流通、生产重点单位）可以在以下位置进行检查：

．化妆品店

．购物中心的商店

．药店

．沙龙

．热门市场

．皮肤科诊所等

9. 化妆品上市后检验的优先顺序是根据产品类型、产地、品牌、公司品牌和配方成分

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

【参考连结】

https://dav.gov.vn/thu-tuc-hanh-chinh.html

HLF-VN-75

越南化妆品审核机构，能够接受海外检验机构的检验资料吗？假如是的话，有些被认可的机构？网页？

HLF-VN-77

HLF-VN-80
外国子公司进口化妆品后，如果委託越南的经销商销售，经销商需要化妆品营业许可证吗？
假如化妆品有品质瑕疵的话，外国子公司和经销商各自的责任为何？是连带责任吗？还是可以规范由外国子公司负责？

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：

无须申请营业特许证，销售之化妆品需取得化妆品收据编号(产品许可证)。

化妆品收据编号持有公司必须遵守

1.确保产品的技术、安全信息随时可供相关监管机构使用，并保存产品分销记录以用于产品召回。

2. 通过电话、传真、电子邮件或书面形式尽快通知管理局致命或危及生命的严重不良事件，最晚不迟于获知后的 7 个日曆日。

3. 产品不良反应报告(按规定格式)必须在第2点所述严重副作用通知主管​​部门之日起 8 个工作日内完成，并提供主管部门要求的任何资料。

4. 立即通知主管当局产品的任何严重但不危及生命或致命的副作用。

5. 使用化妆品不良事件报告表尽快向当局报告所有其他非致命或危及生命的严重不良事件，不迟于知道后的 15 个日曆日。

6.有责任确保产品讯息正确、真实，有责任确保每批产品满足所有法律要求，并向当局申报产品的所有标准和规格。

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.

【参考连结】

https://dav.gov.vn/images/upload_file/2019/cong_bo_tthc_my_pham_1547118988.pdf

HLF-VN-85

请问在越南有哪些专精于化妆品销售与消费权益相关法律服务的业者？

各国化妆品登记法规问答集

Email：han4ww@evershinecpa.com
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