越南化妝品登記法規問題集

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越南永輝BPO有限公司
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各國化妝品登記法規問答集

HLF-VN-10
請問越南對於化妝品的歸類方式為何？它的正式名稱為何？
不同歸類管理強度有何差異?它的政府管轄機構為何？網頁？

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，化妝品是由越南衛生部 (MOH)轄下的越南衛生部藥品管理局(DAV)監管，DAV負責接受、處理申請並對已上市產品進行上市後監督。越南化妝品法規遵循東盟化妝品指令，所有化妝品都需要註冊才能在越南任何地方進口、分銷和銷售。

東盟定義化妝品是任何旨在與人體外部或牙齒和口腔粘膜接觸的物質或製劑，用以清潔、添香、改變外觀和/或改善體臭和/或保護或維持 人體的健康狀況。

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/

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

HLF-VN-20
外國公司要到越南銷售化妝品，無論設100%子公司或分公司，需要在公司登記時取得營業特許證？假如要，其必要條件是什麼？所需文件及申請程序為何？網頁？

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：

無須申請營業特許證。

No business license is required.

【參考連結】

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

HLF-VN-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-VN-30
外國公司要到越南銷售化妝品，可以指派越南公司擔任營業代理人銷售嗎? 擔任營業代理人，其必要條件是什麼？所需文件及申請程序為何？外國公司與營業代理人的產品責任為何?網頁？

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，銷售之化妝品須以越南當地公司名義申請化妝品收據編號 (產品許可證)。

 製造商或產品所有者授權負責將產品推向市場的公司或在越南分銷化妝品的授權書當中，對於進口產品，授權書必須是經過公證的複印件，並作為法律規定進行領事認證，但越南加入的國際條約可免於領事認證。
呈現語言必須為越南語/英語或越南語和英語雙語，並且提供以下內容：

．生產者的名稱、地址

．授權公司的名稱和地址

．授權範圍

．授權產品的標籤或名稱

．授權期限

．產品信息文件（PIF）

．委託方代表的姓名、職務和簽名

化妝品收據編號持有公司必須遵守

1.確保產品的技術、安全信息隨時可供相關監管機構使用，並保存產品分銷記錄以用於產品召回。

2. 通過電話、傳真、電子郵件或書面形式盡快通知管理局致命或危及生命的嚴重不良事件，最晚不遲於獲知後的 7 個日曆日。

3. 產品不良反應報告(按規定格式)必須在第2點所述嚴重副作用通知主管​​部門之日起 8 個工作日內完成，並提供主管部門要求的任何資料。

4. 立即通知主管當局產品的任何嚴重但不危及生命或致命的副作用。

5. 使用化妝品不良事件報告表盡快向當局報告所有其他非致命或危及生命的嚴重不良事件，不遲於知道後的 15 個日曆日。

6.有責任確保產品訊息正確、真實，有責任確保每批產品滿足所有法律要求，並向當局申報產品的所有標準和規格。

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.

【參考連結】

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

HLF-VN-35

HLF-VN-40
外國公司銷售到越南化妝品本身，進口前需要辦理產品許可嗎？如需要，哪個單位在管理？
需要什麼文件？申請程序為何？化妝品包裝內容及各種標示，需要事先核准嗎？可允許的語文有哪些？網頁？

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，須以越南當地公司名義註冊化妝品收據編號(產品許可證)。

流程

1. 負責將化妝品推向市場的當地公司，通過國家單一窗口網頁向越南藥監局(DAV)提交申請。(每件化妝品需要單獨申請)

2. 自收到化妝品申報資料之日起1個工作日內DAV將接收資料。

3.處理化妝品申請資料：

．DAV在收到有效的申請資料和規定的費用起3 個工作日內簽發化妝品收據編號。

．如申請資料不符合要求，DAV應在收到申請日起5個工作日內以電子形式通知申請機構對不符合要求的內容進行修改和補充資料。

．化妝品申請單和/或其他文件的修改、補充應自收到要求補充文件日起5個工作日內回執。

．如果修改和補充的檔案不符合要求，DAV將於收到補充檔案之日起5個工作日內書面通知其不同意簽發化妝品收據編號。

．發送需修改和補充資料的書面通知日起 3 個月內，如DAV未收到補充文件，則該申請將予以公佈不再有效。如果公司想要繼續申請，他們必須提交新的申請並按規定支付新的費用/費用。

3.提交文件

．化妝品聲明

．製造商或產品所有者授權負責將產品推向市場的公司或在越南分銷化妝品的授權書

．自由銷售證書 (CFS)

．化妝品申請表

．產品符合東盟規範之化妝品良好生產規範或等效標準

4.化妝品申請表內容

．產品詳情：品牌、產品名稱、形狀或顏色列表

．產品類型

．預期用途

．產品介绍：單品/多種顏色/產品類型中的顏色表/ 單個套件中的組合產品/其他形式(請註明)

．生產商/包裝商信息(如果有多個請附上清單)：公司名稱、類型(初級包裝/次級包裝)、國家、地址、電話、傳真

．製造商/裝配商詳情(如果有多個請附上清單)：國家、地址、電話、傳真

．負責將化妝品投放市場的當地公司的詳細信息：公司名稱、地址、電話、傳真、營業執照號碼、商業登記號碼、負責人資料

．進口商詳情：公司名稱、地址、電話、傳真

．完整的成分清單(完整的 100% 百分比，國際化妝品成分命名法）

．聲明

5. 製造商或產品所有者授權負責將產品推向市場的公司或在越南分銷化妝品的授權書當中，對於進口產品，授權書必須是經過公證的複印件，並作為法律規定進行領事認證，但越南加入的國際條約可免於領事認證。
呈現語言必須為越南語/英語或越南語和英語雙語，並且必須有足夠的以下內容：

．生產者的名稱、地址

．授權公司的名稱和地址

．授權範圍

．授權產品的標籤或名稱

．授權期限

．產品信息文件（PIF）

．委託方代表的姓名、職務和簽名

6. 自由銷售證書（CFS）

．當前地區簽發的CFS必須是原件或經過合法公證且仍在有效期內。

．如果 CFS 未提供到期日，則必須是24 個月內簽發的證書。

．CFS必須根據法律規定進行領事合法化，但越南加入的國際條約規定的領事合法化豁免情況除外。

7. 產品信息文件（PIF）

．第 1 部分：行政文件和產品摘要

．第 2 部分：成分質量

．第 3 部分：產品質量

．第 4 部分：安全性和有效性

．當局檢查時需要提交 PIF，尤其是第 1 部分文件。 PIF 的其他部分最多可在 2 個月內提交。

8.費用：500,000 越南盾(每件)

9.執行行政程序的要求和條件(如有)

．負責將產品在市場上流通的公司和必須具有在越南交易化妝品的功能。

．化妝品特性聲明(產品的預期用途)必須符合東盟化妝品性能聲明指南。

10.效期：公告卡自簽發之日起5年內有效

標籤

根據東盟化妝品指令，在越南銷售的每種化妝品的包裝標籤上必須包含的信息應包括：

1.產品的名稱和功能，除非產品的呈現形式已經清楚地顯示了產品的功能。

2.使用說明。

3.產品配方的全部成分，所有成分必須按照最新的國際命名法明確說明。

4.製造產品的原產國。

5.英製或國際單位制的重量和體積。

6.負責分銷和銷售產品的公司名稱、說明。應根據商業登記證以越南文註明。

7.標籤上的其他信息可以用英語或越南語書寫。

8.生產批號。

9.必須以 DD/MM/YYYY 或 MM/YYYY 的格式清楚準確地說明生產日期或到期日期。如有必要，可包含有關產品穩定性的說明。

10.對於保質期少於30個月的產品，有效期是強制性的，並且必須印在標籤上。

11.使用安全的警告聲明。

12.所有標籤必須清楚地印在包裝上，以便消費者很容易看到。信息不得從化妝品的包裝中屏蔽或分離。

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】

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
外國公司可以用自己名義申請辦理產品許可嗎？如需要，哪個單位在管理？需要什麼文件？申請程序為何？
化妝品包裝內容及各種標示，需要事先核准嗎？可允許的語文有哪些？？網頁？

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：

須以越南當地公司名義註冊化妝品收據編號(產品許可證)。

流程

1. 負責將化妝品推向市場的當地公司，通過國家單一窗口網頁向越南藥監局(DAV)提交申請。(每件化妝品需要單獨申請)

2. 自收到化妝品申報資料之日起1個工作日內DAV將接收資料。

3.處理化妝品申請資料：

．DAV在收到有效的申請資料和規定的費用起3 個工作日內簽發化妝品收據編號。

．如申請資料不符合要求，DAV應在收到申請日起5個工作日內以電子形式通知申請機構對不符合要求的內容進行修改和補充資料。

．化妝品申請單和/或其他文件的修改、補充應自收到要求補充文件日起5個工作日內回執。

．如果修改和補充的檔案不符合要求，DAV將於收到補充檔案之日起5個工作日內書面通知其不同意簽發化妝品收據編號。

．發送需修改和補充資料的書面通知日起 3 個月內，如DAV未收到補充文件，則該申請將予以公佈不再有效。如果公司想要繼續申請，他們必須提交新的申請並按規定支付新的費用/費用。

3.提交文件

．化妝品聲明

．製造商或產品所有者授權負責將產品推向市場的公司或在越南分銷化妝品的授權書

．自由銷售證書 (CFS)

．化妝品申請表

．產品符合東盟規範之化妝品良好生產規範或等效標準

4.化妝品申請表內容

．產品詳情：品牌、產品名稱、形狀或顏色列表

．產品類型

．預期用途

．產品介绍：單品/多種顏色/產品類型中的顏色表/ 單個套件中的組合產品/其他形式(請註明)

．生產商/包裝商信息(如果有多個請附上清單)：公司名稱、類型(初級包裝/次級包裝)、國家、地址、電話、傳真

．製造商/裝配商詳情(如果有多個請附上清單)：國家、地址、電話、傳真

．負責將化妝品投放市場的當地公司的詳細信息：公司名稱、地址、電話、傳真、營業執照號碼、商業登記號碼、負責人資料

．進口商詳情：公司名稱、地址、電話、傳真

．完整的成分清單(完整的 100% 百分比，國際化妝品成分命名法）

．聲明

5. 製造商或產品所有者授權負責將產品推向市場的公司或在越南分銷化妝品的授權書當中，對於進口產品，授權書必須是經過公證的複印件，並作為法律規定進行領事認證，但越南加入的國際條約可免於領事認證。
呈現語言必須為越南語/英語或越南語和英語雙語，並且必須有足夠的以下內容：

．生產者的名稱、地址

．授權公司的名稱和地址

．授權範圍

．授權產品的標籤或名稱

．授權期限

．產品信息文件（PIF）

．委託方代表的姓名、職務和簽名

6. 自由銷售證書（CFS）

．當前地區簽發的CFS必須是原件或經過合法公證且仍在有效期內。

．如果 CFS 未提供到期日，則必須是24 個月內簽發的證書。

．CFS必須根據法律規定進行領事合法化，但越南加入的國際條約規定的領事合法化豁免情況除外。

7. 產品信息文件（PIF）

．第 1 部分：行政文件和產品摘要

．第 2 部分：成分質量

．第 3 部分：產品質量

．第 4 部分：安全性和有效性

．當局檢查時需要提交 PIF，尤其是第 1 部分文件。 PIF 的其他部分最多可在 2 個月內提交。

8.費用：500,000 越南盾(每件)

9.執行行政程序的要求和條件(如有)

．負責將產品在市場上流通的公司和必須具有在越南交易化妝品的功能。

．化妝品特性聲明(產品的預期用途)必須符合東盟化妝品性能聲明指南。

10.效期：公告卡自簽發之日起5年內有效

標籤

根據東盟化妝品指令，在越南銷售的每種化妝品的包裝標籤上必須包含的信息應包括：

1.產品的名稱和功能，除非產品的呈現形式已經清楚地顯示了產品的功能。

2.使用說明。

3.產品配方的全部成分，所有成分必須按照最新的國際命名法明確說明。

4.製造產品的原產國。

5.英製或國際單位制的重量和體積。

6.負責分銷和銷售產品的公司名稱、說明。應根據商業登記證以越南文註明。

7.標籤上的其他信息可以用英語或越南語書寫。

8.生產批號。

9.必須以 DD/MM/YYYY 或 MM/YYYY 的格式清楚準確地說明生產日期或到期日期。如有必要，可包含有關產品穩定性的說明。

10.對於保質期少於30個月的產品，有效期是強制性的，並且必須印在標籤上。

11.使用安全的警告聲明。

12.所有標籤必須清楚地印在包裝上，以便消費者很容易看到。信息不得從化妝品的包裝中屏蔽或分離。

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】

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
經過核准登記的化妝品，進口到越南要檢附什麼文件？經過什麼手續？
在銷售時要向各地的衛生福利部相關機構事先或事後準備嗎？網頁？

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：

取得進口化妝品的收據編號後可以依據海關流程進口化妝品至越南。

海關流程

1.所有進口到越南的貨物都必須申報並徵稅，除非貨物符合免稅或稅收保護的條件。貿易商可通過國家單一窗口或越南自動清關系統 (VNACCS) 提交所需信息、電子報關單。

2.進口商需自到貨之日起30日內通過VNACCS系統提交完整無誤的電子報關單、運輸單證信息（如提單等）。

3. 申報報關提交文件

．已簽署的報關單（原件）

．商業登記證複印件

．授權書原件或公證副本

．免費銷售證書

．商業發票（複印件）

．銷售合同（複印件）

．定期提單或空運提單

．貨物清單（如有）

．原產地證書（C/O）

．化妝品的收據編號

．裝箱單

．價值聲明（如有）

．收據（如有）

．原產地證書（如有）

4. 按規定繳納稅費，接收清關信息。

5.報關單內容

．報關登記海關分部

．提交日期和時間

．註冊日期和時間

．進口口岸海關分局

．申報附件數量

．出口商、類型

．商業發票

．許可證號

．合同

．進口商

．提單（編號/日期）

．裝貨港、卸貨港

．受託人/委託人

．運輸工具

．出口國

．報關員

．到貨日期

．交貨條件

．付款方式、支付貨幣、稅率

．商品說明、產品代碼、項目、數量、價值等

5.倉儲

．如果進口商不打算立即將貨物投入越南流通，可以根據海關倉庫儲存制度進口到越南。商品入庫時實行稅收保護，商品投入流通時才徵收稅款。

．貿易商在入庫時需要提交保稅倉儲制度下的進口報關單，在貨物進入流通時需要提交正規的進口報關單。

．倉庫有多種類型（保稅倉庫、暫緩稅倉庫），帶入倉庫的貨物必須得到越南海關總署或財政部的批准。

無銷售通知，但在以下任何媒體上的化妝品廣告：廣播、電視、互聯網、報紙、雜誌、海報、活動等均受越南法律監管，並且必須在向公眾展示之前須獲得批准。化妝品廣告的內容必須恰當，不得誤導。它符合東盟化妝品指令規定的產品的有效性、安全性和質量。

1.申請機構：越南衛生部藥品管理局(DAV)

2.登記資料

．登記表：化妝品的名稱、功能和功效、申請人的姓名、地址、使用注意事項等

．化妝品收據編號副本(產品所有公司蓋章)

．商業登記證副本(加蓋印章)

．授權書(產品所有公司蓋章)

．對所使用的音樂、圖片和內容進行清晰描述的廣告場景

．產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

【參考連結】

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
越南化妝品審核機構，需要附上的實驗室檢驗資料有哪些? 網頁？

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

Evershine RD：

產品信息文件（PIF）包括以下內容：

1. 行政文件和產品概要

．帶有國家主管部門收據編號的化妝品公告單複印件

．製造商或產品所有者的授權書或與產品相關的協議書

．自由銷售證明  CFS（針對進口外國化妝品）

．其他相關行政文件（負責將產品推向市場的企業營業執照或投資許可證）

．配方中所有成分和百分比

．標籤和產品信息

．用戶手冊（如果有）

．生產公告

．製造商聲明該產品是按照東南亞國家聯盟 (CGMP-ASEAN) 的化妝品良好生產規範或同等標準的原則和標準製造的

．批號/產品代碼記錄系統

．化妝品安全性評估：安全聲明（帶有簽名的結論、評估者姓名和證書）

．對人類是否有害影響的總結（如果有的話）

．說明化妝品特性和用途的文件（概要）

．根據成分和測試結果評估產品特性和用途的報告

2. 成分質量

．原材料的質量標準和檢測方法，對於香精成分，請註明香精的名稱和編號、供應商的名稱和地址，並承諾遵守國際香精協會 (IFRA) 的指導方針

．供應商提供之材料安全數據，須根據已發布的數據或科學委員會（ACSB、SCCP、CIR）的報告

3. 產品質量

．產品配方：根據國際命名法成分的全稱和配方中成分的百分比

．製造商的詳細信息：製造商的國家、名稱和地址、包裝商

．生產過程、質量控制和相關生產記錄的更詳細信息，應根據管理機構的要求準備

．成品標準及測試方法：微生物限度測試標準、與質量標準相對應的測試方法來檢查通過水平

．產品穩定性總結報告（對於保質期少於 30 個月的產品）、穩定性研究報告和數據或穩定性評估來解釋產品的保質期

4. 安全性和有效性

．安全評估：根據配方中的成分、成分的化學結構和危害閾值評估成品對人體安全的報告（帶有評估者的姓名和簽名）

．產品安全審核員的簡歷

．定期更新的副作用或不良影響（如果有）的最新報告

．說明產品包裝上公佈的產品特性和用途的文件：基於成分和測試結果（帶有姓名和字母）審核員簽名的產品特性和用途評估的完整報告）

化妝品上市後抽檢

化妝品上市後檢驗抽樣重點關注以下產品：

1.分類

．皮膚美白產品

．部分鉻（滑石粉）或含有礦物質的產品

．眼睛和嘴唇的產品

．染髮產品

．供兒童或孕婦使用的產品

2.來源

．非東盟國家

．有不合規產品紀錄的國家

3. 公司、品牌

．違規紀錄數據

．鮮為人知、不知名的公司

4.成分

．含有重金屬、石棉等有毒雜質的有害物質

．某些不允許的雜質，例如 TEA 純度必須高於 99%（最大 DEA 含量 0.5%）或可能與其他成分相互作用的雜質，如硝化劑（水中的亞硝酸鹽）

5. 審查標準和成分重點

．美白產品：汞、對苯二酚、激素（胎盤提取物）

．嬰兒爽身粉：重金屬、石棉（氨）、微生物限度

．眼妝產品：重金屬、微生物限度

．唇部產品：禁用著色劑

．染髮產品：禁用的染色成分

．植物材料：植物保護物質、微生物的殘留物

6. 檢查產品信息概要 (PIF)注意重點

．產品配方

．生產用水標準

．苯的存在

．乙氧基化材料中的二噁烷含量，例如 SLES

．礦物油/凡士林/石蠟必須符合 COLIPA 蒸餾指南的要求

．亞硝胺污染風險（水中的亞硝酸鹽可能是硝化劑的來源）

7.安全評估。

．與質量相關的因素，如文件管理、GMP 聲明、清潔度、生產過程中的衛生

．材料是使用生物技術獲得的（注意基因突變的風險）

．植物提取物（注意使用的溶劑、安全評估、植物保護劑、防腐劑）

8. 測試地點：衛生部藥品管理局(DAV) 列出分銷渠道，化妝品上市後檢驗監管需集中在上游（進口、流通、生產重點單位）可以在以下位置進行檢查：

．化妝品店

．購物中心的商店

．藥店

．沙龍

．熱門市場

．皮膚科診所等

9. 化妝品上市後檢驗的優先順序是根據產品類型、產地、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

【參考連結】

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

HLF-VN-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？

HLF-VN-77

HLF-VN-80
外國子公司進口化妝品後，如果委託越南的經銷商銷售，經銷商需要化妝品營業許可證嗎？
假如化妝品有品質瑕疵的話，外國子公司和經銷商各自的責任為何？是連帶責任嗎？還是可以規範由外國子公司負責？

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：

無須申請營業特許證，銷售之化妝品需取得化妝品收據編號(產品許可證)。

化妝品收據編號持有公司必須遵守

1.確保產品的技術、安全信息隨時可供相關監管機構使用，並保存產品分銷記錄以用於產品召回。

2. 通過電話、傳真、電子郵件或書面形式盡快通知管理局致命或危及生命的嚴重不良事件，最晚不遲於獲知後的 7 個日曆日。

3. 產品不良反應報告(按規定格式)必須在第2點所述嚴重副作用通知主管​​部門之日起 8 個工作日內完成，並提供主管部門要求的任何資料。

4. 立即通知主管當局產品的任何嚴重但不危及生命或致命的副作用。

5. 使用化妝品不良事件報告表盡快向當局報告所有其他非致命或危及生命的嚴重不良事件，不遲於知道後的 15 個日曆日。

6.有責任確保產品訊息正確、真實，有責任確保每批產品滿足所有法律要求，並向當局申報產品的所有標準和規格。

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.

【參考連結】

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

HLF-VN-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？

各國化妝品登記法規問答集

Email：han4ww@evershinecpa.com
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