越南保健食品登記法規問題集
Email：sgn4ww@evershinecpa.com
或
越南永輝BPO有限公司
聯絡人：蘇 玉 燕 副總經理
手機：+886-928-486-835
skype: rachelsu8
wechat: r0928486835
電話：+886-2-2717-0515 分機:104
HLF-VN-10
請問越南對於保健食品的歸類方式為何？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 health food in Vietnam? What is its official name? What is the intensity of management of different categories? What is the governmental authority of health food? Website?
Evershine RD：
在越南，保健食品的主管機構是衛生部（MoH）轄下的越南食品管理局（VFA），負責收集和批准進口保健食品之登記，以及負責發布相關法規。
保健品也稱為食品補充劑、膳食補充劑，用作日常飲食的補充，為提高使用者的健康和免疫力，可能含有以下一種或多種物質：
1. 維生素、礦物質、氨基酸、脂肪酸、酶、益生菌等生物活性物質。
2. 從動物、礦物、植物中以提取物、分離物、濃縮物或代謝物形式提取之物質。
3. 上述物質的組合來源。
保健品可以是軟膠囊、丸劑、片劑、顆粒劑、粉劑、液體和其他劑型，或為更小的劑量。
In Vietnam, the competent authority for health food is the Vietnam Food Administration (VFA) under the Ministry of Health (MoH), which is responsible for collecting and approving the registration of imported health food and issuing relevant regulations.
Health products, also known as food supplements and dietary supplements, are used as a supplement to the daily diet and may contain one or more of the following substances to improve the health and immunity of the user:
1. Bioactive substances such as vitamins, minerals, amino acids, fatty acids, enzymes, and probiotics.
2. Substances extracted in the form of extracts, isolates, concentrates or metabolites from animals, minerals and plants.
3. Combination sources of the above substances.
Nutraceuticals can be in the form of softgels, pills, tablets, granules, powders, liquids and other dosage forms, or in smaller doses.
HLF-VN-20
外國公司要到越南銷售保健食品，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 health food 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://reurl.cc/qNr40g
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保健食品公司營業許可證？
Evershine RD：
無須申請營業特許證。
No business license is required.
HLF-VN-30
外國公司要到越南銷售保健食品，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 health food in Vietnam, can it assign an 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。當地企業/個人身分皆可提出產品許可申請。
保健品是食品類別，因此在越南生產和銷售保健品的生產商、貿易商必須向食品管理局（VFA）提交產品自我公告登記。
申請表內容
1.組織或個人名稱、地址、電話、傳真、電子郵件、業務代碼
2.食品安全合格證書編號、發證日期/地點
3.產品信息：名稱、成分、保質期、包裝規格及包裝材料
4.產品製造商名稱、地址
5.產品聲明
當發現不安全產品時，生產、銷售保健品的個人或企業應召回不安全產品並向越南食品管理局（VFA）提交報告，生產、銷售者應當處理該產品，並承擔全部召回和處理費用。
在某些緊急情況下，國家主管部門可以直接召回和處置不安全食品，並要求生產、銷售者報銷召回和處置費用。
此外，根據消費者權益保護法，一旦發現有缺陷的產品，製造商/貿易商必須立即採取一切必要措施，停止在市場上供應此類產品。這包括召回有缺陷的產品，並在至少連續 5 期日報或連續 5 天在產品流通地區的廣播或電視上發布有關缺陷產品的信息。
此外，如果有缺陷的產品對消費者的生命或健康造成嚴重損害，貿易商/製造商必須向消費者支付賠償。
An application can be made as a local business/person.
Health products are food, so manufacturers and traders who produce and sell health products in Vietnam must submit product self-announcement registration to the Food Administration (VFA).
Contents of the application form
1. Organization or personal name, address, telephone, fax, email, business code
2. Food safety certificate number, date/place of certificate issuance
3. Product information: name, ingredients, expiration date, packaging specifications and packaging materials
4. The name and address of the manufacturer of the product
5. Product Declaration
When unsafe products are found, individuals or enterprises that produce and sell health supplements should recall the unsafe products and submit a report to the Vietnam Food Administration (VFA).
In some emergency situations, the national competent authority can directly recall and dispose of unsafe food, and require the manufacturer and seller to reimburse the recall and disposal costs. Furthermore, in accordance with consumer protection law, as soon as a defective product is discovered, the manufacturer/trader must immediately take all necessary measures to stop supplying such product on the market. This includes recalling defective products and publishing information about defective products in at least 5 consecutive daily newspapers or 5 consecutive days on radio or television in the area in which the product is circulated. In addition, the trader/manufacturer must pay compensation to the consumer if the defective product causes serious damage to the consumer’s life or health.
【參考連結】
HLF-VN-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？
HLF-VN-40
外國公司銷售到越南保健食品本身，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？保健食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 health food sold to Vietnam? If yes, which authority is in charge? What documents are required? What is the application process? Do health food packaging and labeling require prior approval? Which languages are allowed? Website?
Evershine RD：
需要，可以以外國企業/個人、當地企業/個人身分提出申請。
保健品是食品類別，因此在越南生產和銷售保健品的生產商、貿易商必須向食品管理局（VFA）提交產品自我公告登記。
流程
1. 申請人通過網路、郵寄或紙本向衛生部提交進口保健食品產品申報註冊申請。
網頁： https://vfa.gov.vn/dich-vu-cong.html（VFA）
2. 自收到充分文件之日起 21 個工作日內，衛生部將核實申請並簽發註冊產品申報證書。文件核驗時限自收到網上公共服務系統（如果是網上提交申請）或衛生部蓋章（如果是郵寄或直接提交申請）規定的日期開始計算。
3. 如果需要補充，衛生部應當書面說明並說明法律依據，要求申請人補充申請1次。自收到補充申請之日起7個工作日內予以核實並作出書面答覆。申請人自提出書面請求之日起90個工作日內未補正申請的，申請將失效。
4. 產品名稱、產地或成分發生變更的，應另行申請。如有其他變更，申請人應書面通知衛生部，之後有權繼續生產或銷售該產品。
5. 衛生部應在其網站上公佈並在食品安全數據庫中更新其產品聲明已註冊的供應商的名稱和產品。
6. 申請人應按照收費法律規定繳納文件驗證費用。
7. 法規產品自我公告的有效期為 3 年。
8. 只有登記者才可以將產品進口，不同的進口商想要進口相同的產品，必須另外提出註冊。
登記文件包括：
1. 申請表。
2. 原產國或出口國主管當局簽發的自由銷售證明/出口證明/健康證明，內容為確保用戶安全或在生產國/出口國市場上自由銷售（領事認證）。
3. 指定實驗室或符合 ISO17025 的實驗室出具的食品安全數據表原件或經核證無誤的副本(自我聲明前 12 個月內出具的)，數據表必須符合國際法規（如果沒有衛生部的相關法規，則由供應商依據衛生部規定的安全指標為標準）
4. 證明產品或成分用途的科學證據（組織或個人認證的原件或副本），當使用科學證據證明產品的成分用於產品用途時，產品的每日劑量必須至少大於或等於手冊中所述成分使用量的 15%。
5. 進口產品為保健食品需具備食品安全和良好生產規範（GMP）合格證明或同等證明。
．衛生部列入與越南簽署GMP檢查互認協議的國家名單中的製造商。
．ICH（國際人用藥品技術要求協調委員會）國家或澳大利亞的製造商，已通過美國（美國食品和藥物管理局 – USFDA）、歐盟國家（歐洲）的 SRA 之一的 GMP 合規性檢查藥品管理局 – EMA）、澳大利亞（治療用品管理局 – TGA）、日本（藥品和醫療器械管理局 – PMDA）或加拿大（加拿大衛生部）GMP的證明。
．對於未頒布GMP的國家，需以書面形式確認製造商符合保健品或草藥產品和傳統醫藥產品製造的要求和條件，或在主管當局的官方網站上公佈符合性。
6. 定期監測計劃。
7. 產品標籤樣本。原產國的原始標籤和越南語的標籤。
8. 成品樣品。
9. 商業登記證或投資證(經單位或個人認證的食品經營許可證或食品進口商法人資格證明)
10.符合HACCP 或同等標準的證書。
11.註冊文件必須用越南語書寫；其他語言的文件必須翻譯成越南語並經過公證，提交申請時，文件必須未過期。
申請表內容
1.組織或個人名稱、地址、電話、傳真、電子郵件、業務代碼
2.食品安全合格證書編號、發證日期/地點
3.產品信息：名稱、成分、保質期、包裝規格及包裝材料
4.產品製造商名稱、地址
5.產品聲明
標籤
1. 風險警告（如果有）
2. 營養成分：須依據越南人的推薦營養攝入量（RNI）標示
．含量低於 10% RNI 的物質不予提及。
．如果一種物質的含量為10% RNI，則應規定標示其在一份或 100 克產品中的含量。
．品中維生素、礦物質的最大含量不得超過規範，如果是越南沒有規範的RNI，最大含量應符合 CODEX 或相關國際組織的規定。
3. 健康聲稱
．產品中的補充物質含量達到 10% RNI 或以上並有具體科學證據證明時，才可提出有關補充物質的健康聲明。
．對於不含 RNI 的補充成分，只有當它們有科學證據證明或該成分的含量符合已發表的科學文獻的建議時，才應在標籤上做出健康聲明。
．健康聲明必須清晰、一致並適合合適的使用者和劑量。
4. 補充食品的詞組或國家技術法規中的標題名稱
5. 經國家主管部門批准，並書面聲明符合食品安全法規
6. 必須指定被禁止的用戶（如果有）
7. 產品名稱及標籤上的信息必須與申報文件所附的聲明和材料一致
8. 產品須標示保健品
9. 當使用產生產品效果的主要成分作為產品名稱時，必須在主要部分和標籤成分表上的產品名稱旁邊或下方寫上以下信息：
．該主要成分中確定的活性成分含量
．不能確定的主要成分含量
10. 標籤上不得寫藥物代謝動力學。
11. 在產品效果或其他建議（如有）後必須有注意：本產品不是藥物，不能替代藥物的字樣。該短語必須與標籤的背景顏色形成對比色，並且字母必須跨越 1.2 毫米。如果包裹的一側小於 80 平方厘米，則字母必須至少為 0.9 毫米。
12. 使用和保存說明。
13. 負責食品的組織或個人的名稱和地址。
14. 標註來源。
15. 負責商品標籤的組織或個人必須確保標籤上出現的字母、標誌、數字、圖畫、圖像、標記等顏色清晰。特別是，表示強制性信息的顏色必須與標籤的背景顏色形成對比。
16. 表示計量單位的字母和數字的大小必須符合計量法的規定。
17. 所有強制性信息必須用越南語顯示。(不得用外語書寫)
18. 某些內容可以其他拉丁語種呈現，包括：
． 沒有對應越南名稱的藥物之國際名稱或學名
．附有化學、化學物質、輔料或藥物成分的化學式或組成式的國際名稱或學名
．成分的國際名稱或學名以及成分的數量，當該名稱無法翻譯成越南語或越南語翻譯無意義時
．參與貨物製造的外國企業的名稱和地址
An application can be made as a foreign business/person.
Health products are food, so manufacturers and traders who produce and sell health products in Vietnam must submit product self-announcement registration to the Food Administration (VFA).
Process
1. The applicant submits an application for registration of imported health food products to the Ministry of Health through the Internet, by post or in paper.
URL: https://vfa.gov.vn/dich-vu-cong.html(VFA)
2. Within 21 working days from the date of receipt of sufficient documents, the Ministry of Health will verify the application and issue a Certificate of Declaration for Registered Products. The time limit for document verification starts from the date specified by the online public service system (if the application is submitted online) or the stamp of the Ministry of Health (if the application is submitted by post or directly).
3. If supplementation is required, the Ministry of Health shall explain in writing and explain the legal basis, and require the applicant to supplement the application once. The supplementary application will be verified and a written reply will be given within 7 working days from the date of receipt of the supplementary application. If the applicant fails to correct the application within 90 working days from the date of the written request, the application will be invalid.
4. If the product name, place of origin or composition is changed, a separate application should be made. In case of other changes, the applicant shall notify the Ministry of Health in writing, after which the applicant shall have the right to continue producing or selling the product.
5. The Ministry of Health shall publish on its website and update in the food safety database the names and products of the registered suppliers whose product declarations have been made.
6. The applicant shall pay the fee for document verification in accordance with the fee laws.
7. The regulated product self-announcement is valid for 3 years.
8. Only the registrant can import the product. Different importers want to import the same product, they must register separately.
The registration document includes:
1. Application form.
2. Free sale certificate/export certificate/health certificate issued by the competent authority of the country of origin or exporting country, the content of which is to ensure the safety of the user or free sale in the market of the country of origin or exporting country (consular authentication).
3. The original or certified copy of the food safety data sheet (issued within 12 months before the self-declaration) issued by a designated laboratory or a laboratory in compliance with ISO17025, the data sheet must comply with international regulations (if there is no relevant Ministry of Health regulations, the supplier shall be based on the safety indicators stipulated by the Ministry of Health as the standard)
4. Scientific evidence (original or copy certified by the organization or individual) to prove the use of the product or ingredient, when scientific evidence is used to prove that the ingredients of the product are used in the product, the daily dose of the product must be at least greater than or equal to the ingredients stated in the manual 15% of usage.
5. Imported products that are health foods need to have a food safety and good manufacturing practice (GMP) certificate or an equivalent certificate.
． Manufacturers included in the list of countries that have signed a mutual recognition agreement for GMP inspections with Vietnam by the Ministry of Health.
． Manufacturers in ICH (International Committee for Harmonization of Technical Requirements for Medicinal Products for Human Use) countries or Australia that have passed GMP compliance inspections in the United States (US Food and Drug Administration – USFDA), one of the SRAs in EU countries (European Drug Administration) – EMA), Australia (Therapeutic Goods Administration – TGA), Japan (Pharmaceuticals and Medical Devices Authority – PMDA) or Canada (Health Canada) GMP certification.
． For countries that have not promulgated GMP, it is necessary to confirm in writing that the manufacturer complies with the requirements and conditions for the manufacture of nutraceutical or herbal products and traditional medicinal products, or to publish the compliance on the official website of the competent authority.
6. Regular monitoring plan.
7. Sample product label. Original label of country of origin and label in Vietnamese.
8. Finished samples.
9. Business registration certificate or investment certificate (food business license or food importer legal personality certificate certified by the unit or individual)
10. Certificate of compliance with HACCP or equivalent.
11. Registration documents must be written in Vietnamese; documents in other languages must be translated into Vietnamese and notarized, and the documents must be not expired when the application is submitted.
Contents of the application form
1. Organization or personal name, address, telephone, fax, email, business code
2. Food safety certificate number, date/place of certificate issuance
3. Product information: name, ingredients, expiration date, packaging specifications and packaging materials
4. The name and address of the manufacturer of the product
5. Product Declaration
Label
1. Risk warning (if any)
2. Nutritional content: must be declared according to the Recommended Nutrient Intake (RNI) for Vietnamese
． Substances below 10% RNI are not mentioned.
． If a substance is present at 10% RNI, provisions should be made to declare its content in one serving or 100 grams of product.
． The maximum content of vitamins and minerals in the product shall not exceed the specification. If it is an RNI that does not have a specification in Vietnam, the maximum content shall comply with the regulations of CODEX or relevant international organizations.
3. Health Claims
． A health claim for a supplement can only be made if the content of the supplement in the product is 10% RNI or more, supported by specific scientific evidence.
． For supplemental ingredients that do not contain RNI, a health claim should be made on the label only if they are supported by scientific evidence or if the ingredient is present in amounts that meet the recommendations of the published scientific literature.
． Health claims must be clear, consistent and appropriate for the appropriate user and dosage.
4. Phrase of supplementary food or title name in national technical regulations
5. Approved by the national competent authority and declared in writing that it complies with food safety regulations
6. Must specify banned users (if any)
7. The product name and information on the label must be consistent with the declarations and materials attached to the declaration document
8. Products must be labeled as health supplements
9. When using the main ingredient that produces the product’s effect as the product name, the following information must be written next to or below the product name on the main section and on the label ingredient list:
． Active ingredient content determined in the main ingredient
． Undetermined main ingredient content
10. Pharmacokinetics must not be written on the label.
11. After the product effect or other suggestions (if any), there must be a note: This product is not a drug and cannot replace the wording of a drug. The phrase must be a contrasting colour to the label’s background colour and the letters must span 1.2mm. If one side of the package is smaller than 80 cm², the letters must be at least 0.9 mm.
12. Instructions for use and storage.
13. The name and address of the organization or individual responsible for the food.
14. Indicate the source.
15. The organization or individual responsible for product labeling must ensure that the letters, logos, numbers, drawings, images, markings, etc. appearing on the labels are clearly colored. In particular, colors representing mandatory information must contrast with the background color of the label.
16. The size of the letters and numbers representing units of measurement must comply with the Law of Measurement.
17. All mandatory information must be displayed in Vietnamese. (Not written in foreign language)
18. Certain content may be presented in other Latin languages, including:
． International or scientific names of drugs that do not have a Vietnamese counterpart
． International or scientific name with chemical formula or composition formula of chemical, chemical substance, excipient or pharmaceutical ingredient
． The international or scientific name of the ingredient and the quantity of the ingredient, when the name cannot be translated into Vietnamese or Vietnamese translation is meaningless
． The name and address of the foreign business involved in the manufacture of the goods
【參考連結】
HLF-VN-45
請問在越南有哪些專業服務機構，可以協助辦理保健食品產品許可證？
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？保健食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 health food packaging and labeling require prior approval? Which languages are allowed? Website?
Evershine RD：
可以以外國企業/個人身分提出申請。
保健品是食品，因此在越南生產和銷售保健品的生產商、貿易商必須向食品管理局（VFA）提交產品自我公告登記。
流程
1. 申請人通過網路、郵寄或紙本向衛生部提交進口保健食品產品申報註冊申請。
網頁： https://vfa.gov.vn/dich-vu-cong.html（VFA）
2. 自收到充分文件之日起 21 個工作日內，衛生部將核實申請並簽發註冊產品申報證書。文件核驗時限自收到網上公共服務系統（如果是網上提交申請）或衛生部蓋章（如果是郵寄或直接提交申請）規定的日期開始計算。
3. 如果需要補充，衛生部應當書面說明並說明法律依據，要求申請人補充申請1次。自收到補充申請之日起7個工作日內予以核實並作出書面答覆。申請人自提出書面請求之日起90個工作日內未補正申請的，申請將失效。
4. 產品名稱、產地或成分發生變更的，應另行申請。如有其他變更，申請人應書面通知衛生部，之後有權繼續生產或銷售該產品。
5. 衛生部應在其網站上公佈並在食品安全數據庫中更新其產品聲明已註冊的供應商的名稱和產品。
6. 申請人應按照收費法律規定繳納文件驗證費用。
7. 法規產品自我公告的有效期為 3 年。
8. 只有登記者才可以將產品進口，不同的進口商想要進口相同的產品，必須另外提出註冊。
登記文件包括：
1. 申請表。
2. 原產國或出口國主管當局簽發的自由銷售證明/出口證明/健康證明，內容為確保用戶安全或在生產國/出口國市場上自由銷售（領事認證）。
3. 指定實驗室或符合 ISO17025 的實驗室出具的食品安全數據表原件或經核證無誤的副本(自我聲明前 12 個月內出具的)，數據表必須符合國際法規（如果沒有衛生部的相關法規，則由供應商依據衛生部規定的安全指標為標準）
4. 證明產品或成分用途的科學證據（組織或個人認證的原件或副本），當使用科學證據證明產品的成分用於產品用途時，產品的每日劑量必須至少大於或等於手冊中所述成分使用量的 15%。
5. 進口產品為保健食品需具備食品安全和良好生產規範（GMP）合格證明或同等證明。
．衛生部列入與越南簽署GMP檢查互認協議的國家名單中的製造商。
．ICH（國際人用藥品技術要求協調委員會）國家或澳大利亞的製造商，已通過美國（美國食品和藥物管理局 – USFDA）、歐盟國家（歐洲）的 SRA 之一的 GMP 合規性檢查藥品管理局 – EMA）、澳大利亞（治療用品管理局 – TGA）、日本（藥品和醫療器械管理局 – PMDA）或加拿大（加拿大衛生部）GMP的證明。
．對於未頒布GMP的國家，需以書面形式確認製造商符合保健品或草藥產品和傳統醫藥產品製造的要求和條件，或在主管當局的官方網站上公佈符合性。
6. 定期監測計劃。
7. 產品標籤樣本。原產國的原始標籤和越南語的標籤。
8. 成品樣品。
9. 商業登記證或投資證(經單位或個人認證的食品經營許可證或食品進口商法人資格證明)
10.符合HACCP或同等標準的證書。
11.註冊文件必須用越南語書寫；其他語言的文件必須翻譯成越南語並經過公證，提交申請時，文件必須未過期。
申請表內容
1.組織或個人名稱、地址、電話、傳真、電子郵件、業務代碼
2.食品安全合格證書編號、發證日期/地點
3.產品信息：名稱、成分、保質期、包裝規格及包裝材料
4.產品製造商名稱、地址
5.產品聲明
標籤
1. 風險警告（如果有）
2. 營養成分：須依據越南人的推薦營養攝入量（RNI）標示
．含量低於 10% RNI 的物質不予提及。
．如果一種物質的含量為10% RNI，則應規定標示其在一份或 100 克產品中的含量。
．品中維生素、礦物質的最大含量不得超過規範，如果是越南沒有規範的RNI，最大含量應符合 CODEX 或相關國際組織的規定。
3. 健康聲稱
．產品中的補充物質含量達到 10% RNI 或以上並有具體科學證據證明時，才可提出有關補充物質的健康聲明。
．對於不含 RNI 的補充成分，只有當它們有科學證據證明或該成分的含量符合已發表的科學文獻的建議時，才應在標籤上做出健康聲明。
．健康聲明必須清晰、一致並適合合適的使用者和劑量。
4. 補充食品的詞組或國家技術法規中的標題名稱
5. 經國家主管部門批准，並書面聲明符合食品安全法規
6. 必須指定被禁止的用戶（如果有）
7. 產品名稱及標籤上的信息必須與申報文件所附的聲明和材料一致
8. 產品須標示保健品
9. 當使用產生產品效果的主要成分作為產品名稱時，必須在主要部分和標籤成分表上的產品名稱旁邊或下方寫上以下信息：
．該主要成分中確定的活性成分含量
．不能確定的主要成分含量
10. 標籤上不得寫藥物代謝動力學。
11. 在產品效果或其他建議（如有）後必須有注意：本產品不是藥物，不能替代藥物的字樣。該短語必須與標籤的背景顏色形成對比色，並且字母必須跨越 1.2 毫米。如果包裹的一側小於 80 平方厘米，則字母必須至少為 0.9 毫米。
12. 使用和保存說明。
13. 負責食品的組織或個人的名稱和地址。
14. 標註來源。
15. 負責商品標籤的組織或個人必須確保標籤上出現的字母、標誌、數字、圖畫、圖像、標記等顏色清晰。特別是，表示強制性信息的顏色必須與標籤的背景顏色形成對比。
16. 表示計量單位的字母和數字的大小必須符合計量法的規定。
17. 所有強制性信息必須用越南語顯示。(不得用外語書寫)
18. 某些內容可以其他拉丁語種呈現，包括：
． 沒有對應越南名稱的藥物之國際名稱或學名
．附有化學、化學物質、輔料或藥物成分的化學式或組成式的國際名稱或學名
．成分的國際名稱或學名以及成分的數量，當該名稱無法翻譯成越南語或越南語翻譯無意義時
．參與貨物製造的外國企業的名稱和地址
An application can be made as a foreign business/person.
Health products are food, so manufacturers and traders who produce and sell health products in Vietnam must submit product self-announcement registration to the Food Administration (VFA).
Process
1. The applicant submits an application for registration of imported health food products to the Ministry of Health through the Internet, by post or in paper.
URL: https://vfa.gov.vn/dich-vu-cong.html(VFA)
2. Within 21 working days from the date of receipt of sufficient documents, the Ministry of Health will verify the application and issue a Certificate of Declaration for Registered Products. The time limit for document verification starts from the date specified by the online public service system (if the application is submitted online) or the stamp of the Ministry of Health (if the application is submitted by post or directly).
3. If supplementation is required, the Ministry of Health shall explain in writing and explain the legal basis, and require the applicant to supplement the application once. The supplementary application will be verified and a written reply will be given within 7 working days from the date of receipt of the supplementary application. If the applicant fails to correct the application within 90 working days from the date of the written request, the application will be invalid.
4. If the product name, place of origin or composition is changed, a separate application should be made. In case of other changes, the applicant shall notify the Ministry of Health in writing, after which the applicant shall have the right to continue producing or selling the product.
5. The Ministry of Health shall publish on its website and update in the food safety database the names and products of the registered suppliers whose product declarations have been made.
6. The applicant shall pay the fee for document verification in accordance with the fee laws.
7. The regulated product self-announcement is valid for 3 years.
8. Only the registrant can import the product. Different importers want to import the same product, they must register separately.
The registration document includes:
1. Application form.
2. Free sale certificate/export certificate/health certificate issued by the competent authority of the country of origin or exporting country, the content of which is to ensure the safety of the user or free sale in the market of the country of origin or exporting country (consular authentication).
3. The original or certified copy of the food safety data sheet (issued within 12 months before the self-declaration) issued by a designated laboratory or a laboratory in compliance with ISO17025, the data sheet must comply with international regulations (if there is no relevant Ministry of Health regulations, the supplier shall be based on the safety indicators stipulated by the Ministry of Health as the standard)
4. Scientific evidence (original or copy certified by the organization or individual) to prove the use of the product or ingredient, when scientific evidence is used to prove that the ingredients of the product are used in the product, the daily dose of the product must be at least greater than or equal to the ingredients stated in the manual 15% of usage.
5. Imported products that are health foods need to have a food safety and good manufacturing practice (GMP) certificate or an equivalent certificate.
． Manufacturers included in the list of countries that have signed a mutual recognition agreement for GMP inspections with Vietnam by the Ministry of Health.
． Manufacturers in ICH (International Committee for Harmonization of Technical Requirements for Medicinal Products for Human Use) countries or Australia that have passed GMP compliance inspections in the United States (US Food and Drug Administration – USFDA), one of the SRAs in EU countries (European Drug Administration) – EMA), Australia (Therapeutic Goods Administration – TGA), Japan (Pharmaceuticals and Medical Devices Authority – PMDA) or Canada (Health Canada) GMP certification.
． For countries that have not promulgated GMP, it is necessary to confirm in writing that the manufacturer complies with the requirements and conditions for the manufacture of nutraceutical or herbal products and traditional medicinal products, or to publish the compliance on the official website of the competent authority.
6. Regular monitoring plan.
7. Sample product label. Original label of country of origin and label in Vietnamese.
8. Finished samples.
9. Business registration certificate or investment certificate (food business license or food importer legal personality certificate certified by the unit or individual)
10. Certificate of compliance with HACCP or equivalent.
11. Registration documents must be written in Vietnamese; documents in other languages must be translated into Vietnamese and notarized, and the documents must be not expired when the application is submitted.
Contents of the application form
1. Organization or personal name, address, telephone, fax, email, business code
2. Food safety certificate number, date/place of certificate issuance
3. Product information: name, ingredients, expiration date, packaging specifications and packaging materials
4. The name and address of the manufacturer of the product
5. Product Declaration
Label
1. Risk warning (if any)
2. Nutritional content: must be declared according to the Recommended Nutrient Intake (RNI) for Vietnamese
． Substances below 10% RNI are not mentioned.
． If a substance is present at 10% RNI, provisions should be made to declare its content in one serving or 100 grams of product.
． The maximum content of vitamins and minerals in the product shall not exceed the specification. If it is an RNI that does not have a specification in Vietnam, the maximum content shall comply with the regulations of CODEX or relevant international organizations.
3. Health Claims
． A health claim for a supplement can only be made if the content of the supplement in the product is 10% RNI or more, supported by specific scientific evidence.
． For supplemental ingredients that do not contain RNI, a health claim should be made on the label only if they are supported by scientific evidence or if the ingredient is present in amounts that meet the recommendations of the published scientific literature.
． Health claims must be clear, consistent and appropriate for the appropriate user and dosage.
4. Phrase of supplementary food or title name in national technical regulations
5. Approved by the national competent authority and declared in writing that it complies with food safety regulations
6. Must specify banned users (if any)
7. The product name and information on the label must be consistent with the declarations and materials attached to the declaration document
8. Products must be labeled as health supplements
9. When using the main ingredient that produces the product’s effect as the product name, the following information must be written next to or below the product name on the main section and on the label ingredient list:
． Active ingredient content determined in the main ingredient
． Undetermined main ingredient content
10. Pharmacokinetics must not be written on the label.
11. After the product effect or other suggestions (if any), there must be a note: This product is not a drug and cannot replace the wording of a drug. The phrase must be a contrasting colour to the label’s background colour and the letters must span 1.2mm. If one side of the package is smaller than 80 cm², the letters must be at least 0.9 mm.
12. Instructions for use and storage.
13. The name and address of the organization or individual responsible for the food.
14. Indicate the source.
15. The organization or individual responsible for product labeling must ensure that the letters, logos, numbers, drawings, images, markings, etc. appearing on the labels are clearly colored. In particular, colors representing mandatory information must contrast with the background color of the label.
16. The size of the letters and numbers representing units of measurement must comply with the Law of Measurement.
17. All mandatory information must be displayed in Vietnamese. (Not written in foreign language)
18. Certain content may be presented in other Latin languages, including:
． International or scientific names of drugs that do not have a Vietnamese counterpart
． International or scientific name with chemical formula or composition formula of chemical, chemical substance, excipient or pharmaceutical ingredient
． The international or scientific name of the ingredient and the quantity of the ingredient, when the name cannot be translated into Vietnamese or Vietnamese translation is meaningless
． The name and address of the foreign business involved in the manufacture of the goods
【參考連結】
HLF-VN-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保健食品產品許可證？
HLF-VN-60
經過核准登記的保健食品，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 health food 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：
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
．原產國的自由銷售證明
．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）
．保健品的產品自我公告證明，以取得者可以免檢（有食品安全警示的除外）
．裝箱單
．價值聲明（如有）
．收據（如有）
．原產地證書（如有）
．檢驗官為每批貨物簽發的符合食品進口要求的證明書
．食品證明書
．衛生和安全性之文件
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，但必須在廣告前完成認證登記，保健品廣告內容的登記，除符合廣告法的規定外，還必須符合下列規定：
1. 必須有本食品非藥品，不能代替藥品的警告，字跡必須清晰，顏色與背景顏色形成鮮明對比。
2. 時長小於15秒的電視、報紙上的廣告，不要求寫“本食品非藥，不能代替藥”，但必須在廣告中出現警告。
廣告內容認證登記申請文件包括：
1. 申請網頁： https://nghidinh15.vfa.gov.vn/（VFA）
2. 產品公告登記的書面回執和經主管部門認證的產品公告。
3. 產品標籤樣本。
4. 報刊上刊登廣告，必須有廣告文字，並將廣告內容記錄在音像或音像盤上；以其他方式投放廣告的，必須有廣告策劃圖（內容樣本）。
5. 於產品公告中所述產品用途和特點以外的廣告內容，必須有科學文件證明。
6. 申請廣告內容認證的文件必須是越南語；如果有外文文件，必須翻譯成越南文並經過公證。
程序
1. 擁有廣告產品的組織和個人應當向出具產品公告登記回執的機構發送廣告內容證明登記。
2. 10 個工作日內進行審議並返回結果。
3. 對組織或者個人的廣告內容有異議或者要求修改、補充的，受理機構應當書面說明理由和法律依據，只能一次。
4. 自收到書面修改補充申請之日起90個工作日後，組織或者個人不修改、補充檔案的，該檔案不再有效。
5. 接收廣告內容認證登記的機構負責在網站、其電子信息（網站）和食品安全數據庫上公佈獲得食品廣告內容證書的組織和個人的名稱和產品。
6. 註冊廣告內容認證的組織和個人有責任在申請受理機構繳納申請費。
7. 擁有廣告產品的組織和個人；發布廣告的組織和個人只能對已獲得廣告內容證書的產品進行廣告宣傳，並且只能按照已獲得廣告內容證書的內容進行廣告宣傳。
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 are eligible 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 in the country of origin
．Commercial Invoice (photocopy)
．Sales contract (copy)
．Periodic Bill of Lading or Air Waybill
．List of goods (if any)
．Certificate of Origin (C/O)
．Product self-announcement certificate of health care products, so that the acquirer can be exempted from inspection (except for those with food safety warnings)
．Packing List
．Value statement (if any)
．Receipts (if any)
．Certificate of Origin (if any)
．Certificate of compliance with food import requirements issued by an inspector for each shipment
．Food Certificate
．Health and Safety Documentation
4. Pay taxes and fees and receive customs clearance information as required.
5. Contents of customs declaration form
．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 discharge
．Trustee / Settlor
．Yransportation
．Export country
．Customs declarer
．Arrival date
．Delivery terms
．Payment method, payment currency, tax rate
．Commodity description, product code, item, quantity, value, etc.
5. Warehousing
．If the importer does not plan to put the goods into Vietnam for circulation immediately, they can import to 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 the import declaration form under the bonded storage system when entering the warehouse, and they need to submit the formal import declaration form when the goods enter the circulation.
．There are various types of warehouses (bonded warehouses, deferred tax warehouses), and the goods brought into the warehouses must be approved by the Vietnam Customs Department or the Ministry of Finance.
There is no sales notification, but the certification registration must be completed before the advertisement. The registration of the advertisement content of health products must meet the following requirements in addition to the provisions of the Advertising Law:
1. There must be a warning that this food is not a drug and cannot replace a drug, the handwriting must be clear, and the color must be in sharp contrast with the background color.
2. Advertisements on TV and newspapers with a duration of less than 15 seconds are not required to write “This food is not a medicine and cannot be used as a substitute for medicine”, but a warning must appear in the advertisement.
The application documents for advertisement content certification registration include:
1. Application webpage: https://nghidinh15.vfa.gov.vn/ (VFA)
2. Written receipt of product announcement registration and product announcement certified by the competent authority.
3. Sample product label.
4. Advertisements published in newspapers and periodicals must contain advertisement text and record the advertisement content on audio-visual or audio-visual discs; if advertisements are placed in other ways, there must be advertisement planning diagrams (content samples).
5. Advertising content other than the product use and characteristics stated in the product announcement must be proved by scientific documents.
6. The documents applying for the certification of advertising content must be in Vietnamese; if there are documents in foreign languages, they must be translated into Vietnamese and notarized.
Program
1. Organizations and individuals who own advertised products should send the advertisement content certificate to the agency that issued the product announcement registration receipt.
2. Review and return results within 10 working days.
3. If there is any objection to the content of the advertisement of the organization or individual, or it is required to be revised or supplemented, the acceptance agency shall explain the reasons and legal basis in writing, only once.
4. After 90 working days from the date of receipt of the written amendment and supplementary application, if the organization or individual does not revise or supplement the file, the file will no longer be valid.
5. The agency receiving the advertising content certification registration is responsible for publishing the names and products of the organizations and individuals that have obtained the food advertising content certification on the website, its electronic information (website) and food safety database.
6. Organizations and individuals that register for advertising content certification are responsible for paying the application fee at the application acceptance agency.
7. Organizations and individuals who own advertising products; organizations and individuals that publish advertisements can only advertise products that have obtained advertising content certificates, and can only advertise according to the content that has obtained advertising content certificates.
【參考連結】
https://dknsd.customs.gov.vn/Pages/dn.aspx
https://nghidinh15.vfa.gov.vn/
HLF-VN-70
越南保健食品審核機構，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：
1. 指定實驗室或符合 ISO17025 的實驗室出具的食品安全數據表原件或經核證無誤的副本(自我聲明前 12 個月內出具的)，數據表必須符合國際法規（如果沒有衛生部的相關法規，則由供應商依據衛生部規定的安全指標為標準）
．製造商/進口商/供應商/經銷商信息：名稱、地址、電話、網址等
．危害識別：急性毒性、皮膚腐蝕、眼睛刺激、呼吸或皮膚過敏、生殖細胞致突變性、致癌性、生殖毒性等
．成分/成分信息
．急救措施
．消防措施
．設備和應急程序
．處理和儲存
．接觸控制/個人防護
．個人防護裝備 (PPE)
．理化性質
．穩定性和反應
．毒理學資料
．生態信息
．處置注意事項等
2.食品安全和良好生產規範（GMP）合格證明或同等證明。
．建立和維護質量管理體系，以控制生產和分銷過程，確保該企業生產的所有產品均符合公佈的標準並可供人類安全食用，直至到期日。
．足夠數量的人員，具備與其分配的工作崗位相適應的專業資格，並接受過基本的GMP知識、食品安全和相關專業知識的培訓。生產負責人和質量控制負責人必須是該機構的全職員工，並且相互獨立。機構專業負責人必須具有醫學、藥學、營養學、食品安全、食品技術等專業之一的大學本科以上學歷，並具有3年以上相關專業領域的工作經驗。
．車間、設備及附屬設施系統按照使用目的設計、建造和安裝，單向原則，易於清潔，防止和最大程度減少錯誤風險，避免污垢堆積、污染等對產品產生不利影響的因素，並保持日常清潔活動。
．實施和維護有關生產、質量控制、流通和分銷的完整記錄和文件，以檢索每個產品批次的歷史記錄並記錄執行的所有其他活動。
．所有生產操作必須遵循流程和說明。在生產過程中採取檢查和監督措施，防止和避免混淆、污染和交叉污染的風險。執行操作後立即記錄結果或在記錄中完成生產階段後立即記錄結果。
．設有質量控制部門，以確保產品在適當的條件和工藝下製造並符合既定標準；已進行必要的測試；產品質量不合格不准銷售；必須監測產品的穩定性。
．檢測或委託生產的受委託方必須有足夠的廠房、設備和人員，以滿足轉讓方的要求，並符合主管管理機構對檢測或生產保健食品條件的規定。
．有規定投訴處理、產品召回和自檢流程；遵循程序並記錄並保留這些活動的充分記錄等。
3.符合HACCP或同等標準的證書。
．危害分析：從原料採收處理開始，經由加工、包裝、流通乃至最終產品提供消費者為止，進行一科學化及系統化之評估分析整個過程，以了解各種潛在性危害發生之可能性及其危害程度。
．重要管制點：對可能造成顯著危害之製程中某一點、步驟或程序，以有效監控方法(措施與條件)以預防、去除或降低食品危害至最低可以接受之程度。
．建立管制界限
．執行管制監測
．建立矯正措施
．建立記錄系統
．實施Codex HACCP (危害分析及重要管制點)食品衛生系統等
1. The original or certified copy of the food safety data sheet (issued within 12 months prior to the self-declaration) issued by a designated laboratory or ISO17025-compliant laboratory, the data sheet must comply with international regulations (if there is no relevant Ministry of Health regulations, the supplier shall be based on the safety indicators stipulated by the Ministry of Health as the standard)
．Manufacturer/Importer/Supplier/Distributor Information: Name, Address, Phone, Website, etc.
．Hazard identification: acute toxicity, skin corrosion, eye irritation, respiratory or skin allergy, germ cell mutagenicity, carcinogenicity, reproductive toxicity, etc.
．Ingredients/Ingredient Information
．First Aid
．Fire-fighting measures
．Equipment and Emergency Procedures
．Handling and storage
．Exposure Controls/Personal Protection
．Personal Protective Equipment (PPE)
．Physical and chemical properties
．Stability and Responsiveness
．Toxicological information
．Ecology Information
．Handling precautions, etc.
2. Food safety and Good Manufacturing Practice (GMP) certificate of conformity or equivalent.
．Establish and maintain a quality management system to control the production and distribution process to ensure that all products produced by this business meet published standards and are safe for human consumption until the expiration date.
．A sufficient number of personnel with professional qualifications appropriate to their assigned jobs and trained in basic GMP knowledge, food safety and related professional knowledge. The Head of Production and Head of Quality Control must be full-time employees of the facility and be independent of each other. The person in charge of the institution must have a bachelor’s degree or above in one of the majors in medicine, pharmacy, nutrition, food safety, food technology, etc., and have more than 3 years of work experience in related professional fields.
．Workshops, equipment and ancillary facilities systems are designed, constructed and installed in accordance with the purpose of use, one-way principle, easy to clean, prevent and minimize the risk of errors, avoid factors such as dirt accumulation and contamination that adversely affect the product, and maintain daily cleaning activities .
．Implement and maintain complete records and documentation regarding production, quality control, circulation and distribution to retrieve the history of each product batch and record all other activities performed.
．All production operations must follow processes and instructions. Inspection and supervision measures are taken during the production process to prevent and avoid the risk of mix-ups, contamination and cross-contamination. The result is recorded immediately after the action is performed or after the production stage is completed in the record.
．There is a quality control department to ensure that products are manufactured under proper conditions and processes and meet established standards; necessary tests have been carried out; products are not of acceptable quality for sale; product stability must be monitored.
．The entrusted party for testing or entrusted production must have sufficient plant, equipment and personnel to meet the requirements of the transferor and comply with the regulations of the competent management agency on the conditions for testing or producing health food.
．Procedures for complaint handling, product recalls and self-inspection are in place; procedures are followed and adequate records of these activities are recorded and maintained, etc.
3. Certificate of compliance with HACCP or equivalent.
．Hazard analysis: From raw material harvesting and processing, through processing, packaging, distribution and final product delivery to consumers, a scientific and systematic evaluation and analysis of the entire process is carried out to understand the possibility of various potential hazards and their hazards degree.
．Important control point: For a point, step or procedure in the process that may cause significant harm, effective monitoring methods (measures and conditions) are used to prevent, remove or reduce food hazards to a minimum acceptable level.
．Establish regulatory boundaries
．Executive Regulatory Monitoring
．Establish corrective measures
．Establish a system of record
．Implement Codex HACCP (Hazard Analysis and Critical Control Points) food hygiene system, etc.
【參考連結】
https://vfa.gov.vn/thu-tuc-hanh-chinh.html
HLF-VN-75
HLF-VN-77
請問在越南有哪些保健食品檢驗機構可以提供保健食品檢驗服務？網頁？
HLF-VN-80
外國子公司進口保健食品後，如果委託越南的經銷商銷售，經銷商需要保健食品營業許可證嗎？
假如保健食品有品質瑕疵的話，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 health food and entrusts a distributor in Vietnam to sell it, does the distributor need a health food 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。
當發現不安全產品時，生產、銷售保健品的個人或企業應召回不安全產品並向越南食品管理局（VFA）提交報告，生產、銷售者應當處理該產品，並承擔全部召回和處理費用。
在某些緊急情況下，國家主管部門可以直接召回和處置不安全食品，並要求生產、銷售者報銷召回和處置費用。此外，根據消費者權益保護法，一旦發現有缺陷的產品，製造商/貿易商必須立即採取一切必要措施，停止在市場上供應此類產品。
這包括召回有缺陷的產品，並在至少連續 5 期日報或連續 5 天在產品流通地區的廣播或電視上發布有關缺陷產品的信息。此外，如果有缺陷的產品對消費者的生命或健康造成嚴重損害，貿易商/製造商必須向消費者支付賠償。
No business license is required.
When unsafe products are found, individuals or enterprises that produce and sell health supplements should recall the unsafe products and submit a report to the Vietnam Food Administration (VFA).
In some emergency situations, the national competent authority can directly recall and dispose of unsafe food, and require the manufacturer and seller to reimburse the recall and disposal costs. Furthermore, in accordance with consumer protection law, as soon as a defective product is discovered, the manufacturer/trader must immediately take all necessary measures to stop supplying such product on the market. This includes recalling defective products and publishing information about defective products in at least 5 consecutive daily newspapers or 5 consecutive days on radio or television in the area in which the product is circulated. In addition, the trader/manufacturer must pay compensation to the consumer if the defective product causes serious damage to the consumer’s life or health.
【參考連結】
HLF-VN-85
請問在越南有哪些專精於保健食品銷售與消費權益相關法律服務的業者？
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