印尼保健食品登記法規問題集

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各國健康食品登記法規問題集

HLF-ID-10
請問印尼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 Indonesia? 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：

在印尼，保健品是指含有一種或多種維生素、礦物質、氨基酸和/或其他成分的產品，具有營養價值和/或生理作用，旨在滿足營養需求、維持、改善和/或改善健康功能。製作保健品的過程可以有：防腐劑、甜味劑、著色劑、抗氧化劑、香料和/或其他符合規定的附加材料。

印尼食品和藥物管理局（BPOM）負責公共衛生安全的政府部門之一。BPOM 是一個監管和執行機構，負責監督保健品的批准、銷售和分銷，以及上述產品的進口許可。清真產品保證機構（BPJPH）是監管清真保健品並頒發清真證書的機構，印尼法律要求保健品在國內流通、商業交易行為必須取得清真認證。

In Indonesia, nutraceuticals refer to products containing one or more vitamins, minerals, amino acids and/or other ingredients that have nutritional value and/or physiological effects and are intended to meet nutritional needs, maintain, improve and/or improve health functions. The process of making health products can include: preservatives, sweeteners, colorants, antioxidants, flavors and/or other compliant additional materials.

The Indonesian Food and Drug Administration (BPOM) is one of the government departments responsible for public health safety. BPOM is a regulatory and enforcement agency responsible for overseeing the approval, sale and distribution of health supplements, as well as import authorizations for the above-mentioned products. The Halal Product Assurance Agency (BPJPH) is an agency that supervises halal health products and issues halal certificates. Indonesian law requires health products to be circulated in the country and must obtain halal certification for commercial transactions.

【參考連結】

https://www.pom.go.id/new/

HLF-ID-20
外國公司要到印尼銷售保健食品，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 Indonesia, 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：

無須申請營業許可證。

No business license is required.

【參考連結】

https://jdih.pom.go.id/product/search/c7e211f9ce1d27957e65aa35b35c3fe2/all/all/all/3/product/9

HLF-ID-25
假如需要辦理，請問印尼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：

無須申請營業許可證。

HLF-ID-30
外國公司要到印尼銷售保健食品，可以指派印尼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 Indonesia, can it assign a Indonesia 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：

需要由在印尼當地的公司申請流通許可證，可以是製造商/進口商/分銷商，或委託第三方。

進口商需具備條件：

1. 印尼當地的公司

2. 商業執照

3. 進口商許可證

4. 如為委託第三方機構代理，在申請註冊時至少有效期為 3 年

申請流程

1. 線上填寫申請表，備妥產品相關證明文件後上傳至BPOM電子系統

 網頁：http://e-bpom.pom.go.id/

2. 文件審查(人工審查)

3. 合格者發送證號，不合格者退回

4. 每個證號效期為5年，期效屆滿後可重新申請換發

流通許可證持有公司須負責保健品的安全、品質，及不良事件之處理，並向主管機關回報。

A local company in Indonesia is required to apply for a circulation license, either a manufacturer/importer/distributor, or a third party.

Importers are required to:

1. Local company in Indonesia

2. Business License

3. Importer License

4. If you are entrusting a third-party agency, the validity period is at least 3 years at the time of application for registration

The application process

1. Fill in the application form online, prepare the relevant product certification documents and upload it to the BPOM electronic system

 URL: http://e-bpom.pom.go.id/

2. Document review (human review)

3. Those who are qualified will send the certificate number, and those who are not qualified will return it

4. The validity period of each certificate number is five years, after the expiration of the validity period, you can re-apply for a renewal.

The circulation license holder shall be responsible for the safety, quality, and handling of adverse events of health products, and report to the competent authority.

【參考連結】

https://jdih.pom.go.id/product/search/c7e211f9ce1d27957e65aa35b35c3fe2/all/all/all/3/product/9

HLF-ID-35

HLF-ID-40
外國公司銷售到印尼保健食品本身，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 Indonesia?
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。需要由在印尼當地的公司申請流通許可證，可以是製造商/進口商/分銷商，或委託第三方。

進口商需具備條件：

1. 印尼當地的公司

2. 商業執照

3. 進口商許可證

4. 如為委託第三方機構代理，在申請註冊時至少有效期為 3 年

申請流程

1. 線上填寫申請表，備妥產品相關證明文件後上傳至BPOM電子系統

 網頁：http://e-bpom.pom.go.id/

2. 文件審查(人工審查)

3. 合格者發送證號，不合格者退回

4. 每個證號效期為5年，期效屆滿後可重新申請換發

申請文件

1. 繳稅證明

2. 進口商識別號碼

3. 委託授權書(如果有)

4. 原產國GMP證書(需取得印尼辦事處官印)

5. 自由銷售證明(需取得印尼辦事處官印)

6. 產品成分表

7. 完成品分析說明、完成品檢驗分析報告

8. 產品批號意義說明

9. 符合印尼BPOM規格的標籤設計

10.產品檢驗資料

．質量檢測方法和結果，包括原料和成品中有效成分的含量

．印度尼西亞認可實驗室的成品質量測試結果

．測試成品質量的結果

．毒性試驗和藥學試驗結果

．以印度尼西亞人體臨床試驗的耐受性測試結果

．產品副作用報告

．在原產國流通原始產品、包裝和標記的樣品

．符合法律規定保健品的配送設施

．所有使用的產品儲存設施的清單和地址(有一位藥劑師負責的證明)

．印花稅的聲明

．配送設施將接受設施審核(包括增加的設施)

．提交公司賬戶註冊文件和產品註冊文件之前的進口商所在地

包裝與標示

1. 標示必須直接或牢固地印刷在容器和/或包裝上，且不易與包裝分離或分離、褪色和損壞。

2. 所含信息必須客觀、完整且沒有誤導性。

3. 須包含警告以及消費者必須考慮的其他事項之信息。

4. 標示必須包括以下信息：

．產品名稱

．公司名稱、地址

．流通許可證持有人的名稱和地址

．尺寸、含量或淨重

．添加劑

．成分

．可用性聲明

．使用規則/如何使用

．禁忌症、副作用、警告和注意事項

．許可證號

．批號/生產代碼

．保存期限

．儲存方法

．清真標籤

．酒精含量

．二維條碼

．特殊材料的來源信息

．含有營養物質的，須按照規定在標示中註明每日建議攝取量。

5.未規定的其他信息必須附有支持證據及與安全性、有效性(益處)相關的研究。

6. 初級包裝至少需要包含以下資料：

．產品名稱

．公司名稱、地址

．許可證號

．批號/生產代碼

．保存期限

7. 標籤面積小於或等於 10 平方厘米（十平方厘米）的情況下應標示：

．公司名稱、地址

．許可證號

8.信息必須使用印度尼西亞語、阿拉伯數字和拉丁字母書寫和打印，但產品名稱除外，產品名稱可以用印尼語以外的語言書寫。

9.如果上述的信息是使用印尼語、阿拉伯數字和拉丁字母以外的其他語言打印的，則必須附有與從印度尼西亞宣誓翻譯。

10.圖像、顏色和/或其他設計可用作背景，只要不掩蓋標示。

清真認證程序

1. 產品許可證持有公司向BPJPH書面申請清真認證。BPJPH必須在提交後1個工作日內確認申請文件的完整性。

2.根據申請，指定 LPH 對產品的清真狀態進行檢查和/或測試。

3. LPH 指定清真審核員進行產品清真檢查。在生產過程中對營業場所進行產品清真檢查。產品檢驗過程中，如果有成分懷疑清真性，應在實驗室進行檢測。

4.清真審核員將產品清真檢查結果提交給 LPH。LPH 將結果提交給 MUI，並將副本發送給 BPJPH。

5.產品清真度的確定由 MUI 進行，並在 Halal Fatwa Assembly 中進行。清真產品認定法令（Halal Fatwa）由 MUI 提交給 BPJPH，作為頒發清真證書的依據。

6.如果清真教令大會確定經營者申請的產品為清真產品，BPJPH 應在 1 個工作日內簽發清真證書。如果清真法令大會確定產品不是清真產品，BPJPH 將在 1 個工作日內將清真證書申請連同原因退回。

7. 公司必須在申請和註冊清真認證程序之前實施清真保證制度( HAS)。清真保證體係以清真政策為基礎，建立清真管理團隊，編制HAS手冊，進行培訓，編制相關HAS程序，實施內部審計，正確審查管理。

8. 認證文件

．產品清單

．材料清單和材料文件

．屠夫清單（特別是屠宰場）

．產品矩陣

．HAS 手冊

．工藝流程圖

．生產設施地址清單

．清真政策傳播的證據

．內部培訓的證據和內部審計的證據。

9. 註冊清真證書（上傳數據）

10. 監控清真認證過程的預審核和合同付款

11. 執行審計

12. 執行審計後監控

13. 清真證書有效期為4年

14. 提交清真證書的申請者必須：

．提供正確、清晰和真實的信息

．在清真和非清真產品之間分離加工、儲存、包裝、分銷、銷售和展示的位置、場所和設備

．向 BPJPH 報告材料成分的變化

15.獲得清真證書的經營者必須：

．在獲得清真證書的產品上貼上清真標籤

．保持已獲得清真證書的產品的清真

．將清真產品和非清真產品的加工、儲存、包裝、分銷、銷售和展示的地點、場所和設備分開

．如果清真證書的有效期已過，須更新清真證書

．向 BPJPH 報告材料成分的變化

16. 清真標籤：經清真認證的產品必須在外包裝上標明清真，或未經清真認證的非清真信息。已獲得清真證書的經營者必須在以下位置貼上清真標籤：

．產品包裝​​

．產品的特定部分

．產品的具體位置

．清真標籤必須易於查看和閱讀，並且不易擦除、分離和損壞。

Yes. A local company in Indonesia is required to apply for a circulation license, either a manufacturer/importer/distributor, or a third party.

Importers are required to:

1. Local company in Indonesia

2. Business License

3. Importer License

4. If you are entrusting a third-party agency, the validity period is at least 3 years at the time of application for registration

The application process

1. Fill in the application form online, prepare the relevant product certification documents and upload it to the BPOM electronic system

 URL: http://e-bpom.pom.go.id/

2. Document review (human review)

3. Those who are qualified will send the certificate number, and those who are not qualified will return it

4. The validity period of each certificate number is five years, after the expiration of the validity period, you can re-apply for a renewal

Application documents

1. Tax payment certificate

2. Importer’s identification number

3. Power of Attorney (if applicable)

4. GMP certificate for the country of origin (official seal of the Indonesian office is required)

5. Free sales certificate (official seal of Indonesia office is required)

6. Product ingredient list

7. Finished product analysis description, finished product inspection and analysis report

8. Description of the meaning of the batch number of the product

9. Label design conforming to Indonesian BPOM specification

10. Product Inspection Information

．Quality testing methods and results, including the content of active ingredients in raw materials and finished products

．Finished product quality test results from an accredited laboratory in Indonesia

．The result of testing the quality of the finished product

．Toxicity test and pharmaceutical test results

．Tolerability test results from human clinical trials in Indonesia

．Product Side Effects Report

．Circulate samples of original product, packaging and labelling in country of origin

．Legally compliant delivery facilities for health products

．List and addresses of all used product storage facilities (certified by a pharmacist responsible)

．Stamp duty declaration

．Distribution facilities will undergo facility audits (including additional facilities)

．Importer’s location before submitting company account registration documents and product registration documents

Packaging and Labeling

1. The labeling must be directly or securely printed on the container and/or packaging, and not easily separated or separated from the packaging, discolored and damaged.

2. The information included must be objective, complete and not misleading.

3. Must contain information on warnings and other matters that consumers must consider.

4. Labels must include the following information:

．Product

．Company name and address

．The name and address of the circulation licensee

．Dimensions, content or net weight

．Additives

．Element

．Availability Statement

．Rules of use / How to use

．Contraindications, Side Effects, Warnings and Precautions

．Permit number

．Lot/Production Code

．Shelf life

．Storage method

．Halal label

．Alcohol content

．QR code

．Source information for special materials

．If it contains nutrients, the recommended daily intake must be indicated on the label in accordance with the regulations.

5. Other information not specified must be accompanied by supporting evidence and studies related to safety, efficacy (benefit).

6. The primary packaging must contain at least the following materials:

．Product

．Company name and address

．Permit number

．Lot/Production Code

．Shelf life

7. If the area of the label is less than or equal to 10 square centimeters (ten square centimeters), it shall indicate:

．Company name and address

．Permit number

8. Information must be written and typed in Indonesian, Arabic numerals and Latin alphabets, except for product names, which can be written in languages other than Indonesian.

9. If the above information is printed in languages other than Indonesian, Arabic numerals and Latin alphabets, it must be accompanied by a sworn translation from Indonesia.

10. Images, colors, and/or other designs may be used as backgrounds, as long as they do not obscure the markings.

Halal certification process

1. The product license holder shall apply in writing to BPJPH for halal certification. BPJPH must confirm the completeness of the application documents within 1 business day after submission.

2. Upon application, designate LPH to inspect and/or test the halal status of the product.

3. LPH appoints halal auditors to conduct halal inspections of products. Conduct product halal inspections on business premises during production. During the product inspection process, if any ingredients are suspected of being halal, they should be tested in the laboratory.

4. The halal auditor submits the product halal inspection result to LPH. LPH submits results to MUI and sends a copy to BPJPH.

5. The determination of product halal level is carried out by MUI and in Halal Fatwa Assembly. The Halal Product Recognition Decree (Halal Fatwa) is submitted by MUI to BPJPH as the basis for issuing Halal certificates.

6. BPJPH shall issue a halal certificate within 1 working day if the halal decree meeting determines that the product applied by the operator is halal. If the Halal Decree Assembly determines that the product is not Halal, BPJPH will return the Halal certificate application with the reason within 1 working day.

7. The company must implement the Halal Assurance System (HAS) before applying and registering for the Halal certification process. The halal assurance system is based on the halal policy, establishes a halal management team, compiles a HAS manual, conducts training, compiles relevant HAS procedures, implements internal audits, and properly reviews management.

8. Certification documents

． Product List

． Bill of Materials and Material Documentation

． Butcher’s List (especially slaughterhouses)

． Product Matrix

． HAS Manual

． Flow chart

． Production Facility Address List

． Evidence of the spread of the halal policy

． Evidence of internal training and evidence of internal audit.

9. Register Halal Certificate (Upload Data)

10. Monitor the pre-audit and contract payments for the halal certification process

11. Perform an audit

12. Perform post-audit monitoring

13. Halal certificate is valid for 4 years

14. Applicants submitting a halal certificate must:

．Provide correct, clear and truthful information

．Separation of locations, premises and equipment between halal and non-halal products for processing, storage, packaging, distribution, sale and display

．Reporting changes in material composition to BPJPH

15. Operators who have obtained a Halal certificate must:

．Put a halal label on products with a halal certificate

．Maintain halal for products that have obtained a halal certificate

．Separate locations, premises and equipment for processing, storage, packaging, distribution, sale and display of halal and non-halal products

．If the validity period of the halal certificate has passed, the halal certificate must be renewed

．Report changes to material composition to BPJPH

16. Halal Label: Halal certified products must be marked on the outer packaging as Halal, or non-Halal information that is not Halal certified. Operators who have obtained a halal certificate must affix a halal label at the following locations:

．Product packaging

．Specific part of the product

．The exact location of the product

．Halal labels must be easy to see and read, and not easily erased, detached and damaged.

【參考連結】

https://jdih.pom.go.id/download/product/1337/-/2022

https://jdih.pom.go.id/download/product/1008/-/2017

http://www.halal.go.id/

HLF-ID-45

HLF-ID-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 circulation 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：

需要。需要由在印尼當地的公司申請流通許可證，可以是製造商/進口商/分銷商，或委託第三方。

進口商需具備條件：

1. 印尼當地的公司

2. 商業執照

3. 進口商許可證

4. 如為委託第三方機構代理，在申請註冊時至少有效期為 3 年

申請流程

1. 線上填寫申請表，備妥產品相關證明文件後上傳至BPOM電子系統

 網頁：http://e-bpom.pom.go.id/

2. 文件審查(人工審查)

3. 合格者發送證號，不合格者退回

4. 每個證號效期為5年，期效屆滿後可重新申請換發

申請文件

1. 繳稅證明

2. 進口商識別號碼

3. 委託授權書(如果有)

4. 原產國GMP證書(需取得印尼辦事處官印)

5. 自由銷售證明(需取得印尼辦事處官印)

6. 產品成分表

7. 完成品分析說明、完成品檢驗分析報告

8. 產品批號意義說明

9. 符合印尼BPOM規格的標籤設計

10.產品檢驗資料

．質量檢測方法和結果，包括原料和成品中有效成分的含量

．印度尼西亞認可實驗室的成品質量測試結果

．測試成品質量的結果

．毒性試驗和藥學試驗結果

．以印度尼西亞人體臨床試驗的耐受性測試結果

．產品副作用報告

．在原產國流通原始產品、包裝和標記的樣品

．符合法律規定保健品的配送設施

．所有使用的產品儲存設施的清單和地址(有一位藥劑師負責的證明)

．印花稅的聲明

．配送設施將接受設施審核(包括增加的設施)

．提交公司賬戶註冊文件和產品註冊文件之前的進口商所在地

包裝與標示

1. 標示必須直接或牢固地印刷在容器和/或包裝上，且不易與包裝分離或分離、褪色和損壞。

2. 所含信息必須客觀、完整且沒有誤導性。

3. 須包含警告以及消費者必須考慮的其他事項之信息。

4. 標示必須包括以下信息：

．產品名稱

．公司名稱、地址

．流通許可證持有人的名稱和地址

．尺寸、含量或淨重

．添加劑

．成分

．可用性聲明

．使用規則/如何使用

．禁忌症、副作用、警告和注意事項

．許可證號

．批號/生產代碼

．保存期限

．儲存方法

．清真標籤

．酒精含量

．二維條碼

．特殊材料的來源信息

．含有營養物質的，須按照規定在標示中註明每日建議攝取量。

5.未規定的其他信息必須附有支持證據及與安全性、有效性(益處)相關的研究。

6. 初級包裝至少需要包含以下資料：

．產品名稱

．公司名稱、地址

．許可證號

．批號/生產代碼

．保存期限

7. 標籤面積小於或等於 10 平方厘米（十平方厘米）的情況下應標示：

．公司名稱、地址

．許可證號

8.信息必須使用印度尼西亞語、阿拉伯數字和拉丁字母書寫和打印，但產品名稱除外，產品名稱可以用印尼語以外的語言書寫。

9.如果上述的信息是使用印尼語、阿拉伯數字和拉丁字母以外的其他語言打印的，則必須附有與從印度尼西亞宣誓翻譯。

10.圖像、顏色和/或其他設計可用作背景，只要不掩蓋標示。

清真認證程序

1.產品許可證持有公司向BPJPH書面申請清真認證。BPJPH必須在提交後1個工作日內確認申請文件的完整性。

2.根據申請，指定 LPH 對產品的清真狀態進行檢查和/或測試。

3. LPH 指定清真審核員進行產品清真檢查。在生產過程中對營業場所進行產品清真檢查。產品檢驗過程中，如果有成分懷疑清真性，應在實驗室進行檢測。

4.清真審核員將產品清真檢查結果提交給 LPH。LPH 將結果提交給 MUI，並將副本發送給 BPJPH。

5.產品清真度的確定由 MUI 進行，並在 Halal Fatwa Assembly 中進行。清真產品認定法令（Halal Fatwa）由 MUI 提交給 BPJPH，作為頒發清真證書的依據。

6.如果清真教令大會確定經營者申請的產品為清真產品，BPJPH 應在 1 個工作日內簽發清真證書。如果清真法令大會確定產品不是清真產品，BPJPH 將在 1 個工作日內將清真證書申請連同原因退回。

7. 公司必須在申請和註冊清真認證程序之前實施清真保證制度( HAS)。清真保證體係以清真政策為基礎，建立清真管理團隊，編制HAS手冊，進行培訓，編制相關HAS程序，實施內部審計，正確審查管理。

8. 認證文件

．產品清單

．材料清單和材料文件

．屠夫清單（特別是屠宰場）

．產品矩陣

．HAS 手冊

．工藝流程圖

．生產設施地址清單

．清真政策傳播的證據

．內部培訓的證據和內部審計的證據。

9. 註冊清真證書（上傳數據）

10. 監控清真認證過程的預審核和合同付款

11. 執行審計

12. 執行審計後監控

13. 清真證書有效期為4年

14. 提交清真證書的申請者必須：

．提供正確、清晰和真實的信息

．在清真和非清真產品之間分離加工、儲存、包裝、分銷、銷售和展示的位置、場所和設備

．向 BPJPH 報告材料成分的變化

15.獲得清真證書的經營者必須：

．在獲得清真證書的產品上貼上清真標籤

．保持已獲得清真證書的產品的清真

．將清真產品和非清真產品的加工、儲存、包裝、分銷、銷售和展示的地點、場所和設備分開

．如果清真證書的有效期已過，須更新清真證書

．向 BPJPH 報告材料成分的變化

16. 清真標籤：經清真認證的產品必須在外包裝上標明清真，或未經清真認證的非清真信息。已獲得清真證書的經營者必須在以下位置貼上清真標籤：

．產品包裝​​

．產品的特定部分

．產品的具體位置

．清真標籤必須易於查看和閱讀，並且不易擦除、分離和損壞。

Yes. A local company in Indonesia is required to apply for a circulation license, either a manufacturer/importer/distributor, or a third party.

Importers are required to:

1. Local company in Indonesia

2. Business License

3. Importer License

4. If you are entrusting a third-party agency, the validity period is at least 3 years at the time of application for registration

The application process

1. Fill in the application form online, prepare the relevant product certification documents and upload it to the BPOM electronic system

 URL: http://e-bpom.pom.go.id/

2. Document review (human review)

3. Those who are qualified will send the certificate number, and those who are not qualified will return it

4. The validity period of each certificate number is five years, after the expiration of the validity period, you can re-apply for a renewal

Application documents

1. Tax payment certificate

2. Importer’s identification number

3. Power of Attorney (if applicable)

4. GMP certificate for the country of origin (official seal of the Indonesian office is required)

5. Free sales certificate (official seal of Indonesia office is required)

6. Product ingredient list

7. Finished product analysis description, finished product inspection and analysis report

8. Description of the meaning of the batch number of the product

9. Label design conforming to Indonesian BPOM specification

10. Product Inspection Information

．Quality testing methods and results, including the content of active ingredients in raw materials and finished products

．Finished product quality test results from an accredited laboratory in Indonesia

．The result of testing the quality of the finished product

．Toxicity test and pharmaceutical test results

．Tolerability test results from human clinical trials in Indonesia

．Product Side Effects Report

．Circulate samples of original product, packaging and labelling in country of origin

．Legally compliant delivery facilities for health products

．List and addresses of all used product storage facilities (certified by a pharmacist responsible)

．Stamp duty declaration

．Distribution facilities will undergo facility audits (including additional facilities)

．Importer’s location before submitting company account registration documents and product registration documents

Packaging and Labeling

1. The labeling must be directly or securely printed on the container and/or packaging, and not easily separated or separated from the packaging, discolored and damaged.

2. The information included must be objective, complete and not misleading.

3. Must contain information on warnings and other matters that consumers must consider.

4. Labels must include the following information:

．Product

．Company name and address

．The name and address of the circulation licensee

．Dimensions, content or net weight

．Additives

．Element

．Availability Statement

．Rules of use / How to use

．Contraindications, Side Effects, Warnings and Precautions

．Permit number

．Lot/Production Code

．Shelf life

．Storage method

．Halal label

．Alcohol content

．QR code

．Source information for special materials

．If it contains nutrients, the recommended daily intake must be indicated on the label in accordance with the regulations.

5. Other information not specified must be accompanied by supporting evidence and studies related to safety, efficacy (benefit).

6. The primary packaging must contain at least the following materials:

．Product

．Company name and address

．Permit number

．Lot/Production Code

．Shelf life

7. If the area of the label is less than or equal to 10 square centimeters (ten square centimeters), it shall indicate:

．Company name and address

．Permit number

8. Information must be written and typed in Indonesian, Arabic numerals and Latin alphabets, except for product names, which can be written in languages other than Indonesian.

9. If the above information is printed in languages other than Indonesian, Arabic numerals and Latin alphabets, it must be accompanied by a sworn translation from Indonesia.

10. Images, colors, and/or other designs may be used as backgrounds, as long as they do not obscure the markings.

Halal certification process

1. The product license holder shall apply in writing to BPJPH for halal certification. BPJPH must confirm the completeness of the application documents within 1 business day after submission.

2. Upon application, designate LPH to inspect and/or test the halal status of the product.

3. LPH appoints halal auditors to conduct halal inspections of products. Conduct product halal inspections on business premises during production. During the product inspection process, if any ingredients are suspected of being halal, they should be tested in the laboratory.

4. The halal auditor submits the product halal inspection result to LPH. LPH submits results to MUI and sends a copy to BPJPH.

5. The determination of product halal level is carried out by MUI and in Halal Fatwa Assembly. The Halal Product Recognition Decree (Halal Fatwa) is submitted by MUI to BPJPH as the basis for issuing Halal certificates.

6. BPJPH shall issue a halal certificate within 1 working day if the halal decree meeting determines that the product applied by the operator is halal. If the Halal Decree Assembly determines that the product is not Halal, BPJPH will return the Halal certificate application with the reason within 1 working day.

7. The company must implement the Halal Assurance System (HAS) before applying and registering for the Halal certification process. The halal assurance system is based on the halal policy, establishes a halal management team, compiles a HAS manual, conducts training, compiles relevant HAS procedures, implements internal audits, and properly reviews management.

8. Certification documents

． Product List

． Bill of Materials and Material Documentation

． Butcher’s List (especially slaughterhouses)

． Product Matrix

． HAS Manual

． Flow chart

． Production Facility Address List

． Evidence of the spread of the halal policy

． Evidence of internal training and evidence of internal audit.

9. Register Halal Certificate (Upload Data)

10. Monitor the pre-audit and contract payments for the halal certification process

11. Perform an audit

12. Perform post-audit monitoring

13. Halal certificate is valid for 4 years

14. Applicants submitting a halal certificate must:

．Provide correct, clear and truthful information

．Separation of locations, premises and equipment between halal and non-halal products for processing, storage, packaging, distribution, sale and display

．Reporting changes in material composition to BPJPH

15. Operators who have obtained a Halal certificate must:

．Put a halal label on products with a halal certificate

．Maintain halal for products that have obtained a halal certificate

．Separate locations, premises and equipment for processing, storage, packaging, distribution, sale and display of halal and non-halal products

．If the validity period of the halal certificate has passed, the halal certificate must be renewed

．Report changes to material composition to BPJPH

16. Halal Label: Halal certified products must be marked on the outer packaging as Halal, or non-Halal information that is not Halal certified. Operators who have obtained a halal certificate must affix a halal label at the following locations:

．Product packaging

．Specific part of the product

．The exact location of the product

．Halal labels must be easy to see and read, and not easily erased, detached and damaged.

【參考連結】

https://jdih.pom.go.id/download/product/1337/-/2022

https://jdih.pom.go.id/download/product/1008/-/2017

http://www.halal.go.id/

HLF-ID-55

HLF-ID-60
經過核准登記的保健食品，進口到印尼要檢附什麼文件？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 Indonesia? 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. 至海關總局註冊並取得海關註冊編號(NIK)

 網頁：https://customer.beacukai.go.id/index.html?page=registrasi

2. 取得進口許可證，有效期為5年，其後可以續期。

3. 進口許可證可透過電子資料聯通(EDI)管理，並分為兩類：

．一般進口商註冊編號(API-U)：適用於普通貿易

．生產型進口商註冊編號(API-P) ：適用於進口自用商品的進口商，例如原材料、輔助材料及/或其他用作支援生產過程的產品

4. 填妥進口申報表並向海關總局提交，包含：

．進口申報表

．發票

．包裝清單

．提單

．保險保單

．進口關稅

．相關稅項收據等。

5. 在取得進出口商代碼和進口許可證後，進口商應確定並申報進口物品的來源或產地，並遵從清關手續。

6. 計算進口關稅率(輸入任何進口貨物的進口商，應自行評估對此類貨物徵收的關稅)

7. 須提供資料

．姓名、完整的營業地址

．保存或儲存通知貨物的場所的情況和描述

．貨物的詳情

．日期以及收到此類貨物的人的姓名和完整地址

．貨物所有人的姓名

．貨物的名稱

．取出貨物場所的位置

．通知貨物被運往場所的位置

．運輸工具(如果使用機動車輛運輸通知貨物，需填寫機動車輛的登記號。）

．運輸路線、開始運輸的時間日期、可能到達目的地的時間和日期

．銷售或轉讓通知貨物的人的姓名和完整的營業地址

．向其出售或轉讓通知貨物的人的姓名和完整地址

．出售或轉讓的時間和日期

．貨物的數量、市場價格

．序列號(如果有)

．批號(如果有)

．專利號(如果有)

．製造商、原產國(如果有)

．品牌(如果有)

．商標(如果有)

8.貨物在獲准入境前不得從船上卸貨

9.僅在批准的地點卸貨和裝貨

10.進口商在出示入境單時應就該入境單的內容的真實性作出並簽署聲明，並應為支持該聲明，向有關官員出示發票（如有）以及可能規定的與進口貨物有關的其他文件

11. 入境單的進口商應確保以下事項

．提供信息的準確性和完整性

．任何支持它的文件的真實性和有效性

．遵守本法或當時有效的任何其他法律對貨物的限制或禁止

取得流通許可證即可上市，無須銷售通知。

Customs procedures

1. Register at the General Administration of Customs and obtain a Customs Registration Number (NIK)

 URL: https://customer.beacukai.go.id/index.html?page=registrasi

2. Obtain the import license, which is valid for 5 years, and can be renewed thereafter.

3. Import licenses can be managed through Electronic Data Interconnection (EDI) and are classified into two categories:

． General Importer Registration Number (API-U): for general trade

． Production Importer Registration Number (API-P): For importers of goods for their own use, such as raw materials, auxiliary materials and/or other products used to support the production process

4. Complete the import declaration form and submit it to the General Administration of Customs, which includes:

． Invoice

． Packaging List

． B/L

． Insurance policy

． Import duty

． Relevant tax receipts, etc.

5. After obtaining the importer and exporter code and import license, the importer should determine and declare the source or origin of the imported goods and follow the customs clearance procedures.

6. Calculation of import duty rates (importers who import any imported goods should assess their own duties on such goods)

7. Information required

．Name, full business address

．Conditions and description of the premises where the notified goods are kept or stored

．Details of the goods

．The date and the name and full address of the person who received such shipment

．The name of the owner of the goods

．The name of the goods

．The location of the place where the goods are taken out

．Notify the location of the goods being shipped to the premises

．Means of transportation (If a motor vehicle is used to transport the notified goods, the registration number of the motor vehicle is required.)

．Shipping route, time and date of start of shipment, possible time and date of arrival at destination

．The name and full business address of the person who sold or transferred the notified goods

．Name and full address of the person to whom the notified goods are sold or transferred

．Time and date of sale or assignment

．Quantity of goods, market price

．Serial number (if available)

．Lot number (if available)

．Patent number (if applicable)

．Manufacturer, country of origin (if applicable)

．Brand (if available)

．Trademark (if applicable)

8. The cargo shall not be unloaded from the vessel before it is allowed to enter the country

9. Only unload and load goods at approved locations

10. The importer shall make and sign a declaration on the authenticity of the contents of the entry document when presenting the entry document, and shall, in support of the declaration, present to the relevant officials the invoice (if any) and other provisions related to the imported goods as may be stipulated. document

11. The importer of the entry note shall ensure the following

．Accuracy and completeness of information provided

．The authenticity and validity of any documents that support it

．Comply with any restrictions or prohibitions on the Goods under this Act or any other law then in force

Once a circulation license is obtained, it can be marketed without notice of sale.

【參考連結】

https://www.beacukai.go.id/index.html

HLF-ID-70
印尼保健食品審核機構，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：

在印尼，保健品欲申請上市許可需要由政府直接核發或政府授權機構核發的良好生產規範(在申請註冊時至少還有 1 年的有效期)，可以是：

1. 良好生產規範 (GMP)

2. 良好的傳統藥物製造方法（CPOTB）

3. 加工食品良好生產規範 (CPPOB)

對進口保健品申請上市許可，亦要求出示該國政府直接核發或政府授權機構核發的良好生產規範證明，需具備下列其中一項條件

1. 由原產國政府主管部門簽發並經印尼地方政府代表官員授權的進口產品

2. 由原產國政府主管部門或政府指定的其他機構簽發並經印尼地方政府當地代表官員批准的自由銷售證明或藥品證明。

產品許可時需要繳交保健品質量要求評估申請表並附上實驗是檢驗資料：

申請表內容

1. 申請人姓名

2. 公司名稱

3. 公司地址

4. 聯繫人

5. 電話/傳真/電子郵件

6.  類別 : 國內/進口/許可證已提交申請)

7. 姓名、簽名和公司印章

8. 一般信息

．產品/材料名稱

．產品資料

9. 準備表格

．包裝

．流通許可證號

．作品

．建議用途

．建議使用規則

10.註冊人

．註冊人姓名

．註冊人地址

11. 製造商

．生產商名稱

．製造商地址

12 如果具備許可證

． 許可人名稱

． 許可人地址

．特別信息

13. 用作保健品的歷史

14. 標準藥典專著

15. 各國監管狀況

16. 支持材料/產品安全的數據（毒性測試結果、國際安全狀態，例如 JECFA、GRAS）

17. 支持材料/產品效益的數據（已進行、發表的研究結果）

18. 其他證明文件（如果需要）

19. 活性成分表

．名稱

．印度尼西亞語

．CAS 編號*

．同義詞 *

．功能

．分子量

．常用劑量

．最高限額

．參考數目

．AKG / ALG

實驗室檢驗數據

1. 授權的實驗室

2. 具有良好生產規範證書的工業實驗室

需要具備測試參數包括：

1. 物理參數

．外觀

．硬度/脆性

．崩解時間

．黏度

．酸鹼度

．顆粒/顆粒大小

．可重懸性

．附著力（黏合強度）

2. 化學參數

．速率頻率

．含水量

3. 微生物參數

．微生物污染

4. 重金屬污染

5. 酒精含量的測定

6. 比重和 pH 值

7. 活性成分的鑑定

8. 活性成分的測定等

9. 可以對包含某些利益聲明的成品進行定性鑑定

In Indonesia, for health products to apply for marketing authorization, they need to be directly issued by the government or issued by a government-authorized body of good manufacturing practices (with at least one year of validity at the time of registration application), which can be:

1. Good Manufacturing Practice (GMP)

2. Good Traditional Pharmaceutical Manufacturing Practice (CPOTB)

3. Processed Food Good Manufacturing Practices (CPPOB)

To apply for a marketing license for imported health products, it is also required to present a certificate of good manufacturing practice issued directly by the government of the country or by an agency authorized by the government, and one of the following conditions must be met

1. Imported products issued by the competent government authority of the country of origin and authorized by the Indonesian local government representative officials

2. A certificate of free sale or a drug certificate issued by the competent government authority of the country of origin or other agency designated by the government and approved by the local representative officer of the local government in Indonesia.

When the product is licensed, it is necessary to submit the application form for the evaluation of the quality requirements of health products and attach the test data:

Contents of the application form

1. Name of applicant

2. Company name

3. Company address

4. Contacts

5. Telephone/Fax/E-mail

6. Category : Domestic/Import/License submitted application)

7. Name, Signature and Company Stamp

8. General Information

． Product/Material Name

． Product information

9. Prepare the form

． Package

． Distribution license number

． Work

． Suggested use

． Recommended rules for use

10. Registrant

． Registrant Name

． Registrant Address

11. Manufacturer

． Manufacturer name

． Manufacturer’s address

12 If licensed

． Licensor’s name

． Licensor’s address

． Special information

13. History of use as a supplement

14. Standard Pharmacopoeia monographs

15. Regulatory status in each country

16. Data in support of material/product safety (toxicity test results, international safety status, e.g. JECFA, GRAS)

17. Data to support material/product benefits (results of conducted, published studies)

18. Additional supporting documents (if required)

19. Active ingredient list

． Name

． Indonesian

． CAS number*

． Synonyms *

． Function

． Molecular mass

． Usual dosage

． Maximum limit

． Reference number

． AKG/ALG

Laboratory inspection data

1. Authorized Labs

2. Industrial laboratories with Good Manufacturing Practice certificates

The test parameters that are required include:

1. Physical parameters

．Exterior

．Hardness/Brittleness

．Disintegration Time

．Viscous

．pH

．Particles/Particle Size

．Resuspensibility

．Adhesion (bond strength)

2. Chemical parameters

．Rate frequency

．Water content

3. Microbial parameters

．Microbial contamination

4. Heavy metal pollution

5. Determination of alcohol content

6. Specific Gravity and pH

7. Identification of Active Ingredient

8. Determination of active ingredients, etc.

9. Qualitative identification of finished products that contain certain declarations of interest

【參考連結】

https://jdih.pom.go.id/download/product/840/17/2019

HLF-ID-75

HLF-ID-77

HLF-ID-80
外國子公司進口保健食品後，如果委託印尼的經銷商銷售，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 Indonesia 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：

無須申請營業許可證。流通許可證持有公司須負責保健品的安全、品質，及不良事件之處理，並向主管機關回報。

No business license is required. The circulation license holder shall be responsible for the safety, quality, and handling of adverse events of health products, and report to the competent authority.

【參考連結】

https://jdih.pom.go.id/product/search/c7e211f9ce1d27957e65aa35b35c3fe2/all/all/all/3/product/9

HLF-ID-85

各國健康食品登記法規問題集

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