印尼保健食品登记法规问题集

Email：jkt4ww@evershinecpa.com
或
印尼永辉BPO有限公司
Jakarta time zone:
The Engaging Manager Cindy Luo, Indonesia citizenship, speaks English, Bahasa and Chinese
或
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联络人: 朱键彰 Jerry Chu 协理
手机：+886-939-357735
skype: jc0096
wechat: jc0096
电话：+886-2-2717-0515 分机:103

各国健康食品登记法规问题集

HLF-ID-10
请问印尼对于保健食品的归类方式为何？它的正式名称为何？
不同归类管理强度有何差异?它的政府管辖机构为何？网页？

What are the categories of 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，保健品是指含有一种或多种维生素、矿物质、氨基酸和/或其他成分的产品，具有营养价值和/或生理作用，旨在满足营养需求、维持、改善和/或改善健康功能。製作保健品的过程可以有：防腐剂、甜味剂、着色剂、抗氧化剂、香料和/或其他符合规定的附加材料。

印尼食品和药物管理局（BPOM）负责公共卫生安全的政府部门之一。BPOM 是一个监管和执行机构，负责监督保健品的批准、销售和分销，以及上述产品的进口许可。清真产品保证机构（BPJPH）是监管清真保健品并颁发清真证书的机构，印尼法律要求保健品在国内流通、商业交易行为必须取得清真认证。

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.

【参考连结】

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

HLF-ID-20
外国公司要到印尼销售保健食品，无论设100%子公司或分公司，需要在公司登记时取得营业特许证？
假如要，其必要条件是什麽？所需文件及申请程序为何？网页？

If a foreign company wants to sell 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：

无须申请营业许可证。

No business license is required.

【参考连结】

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

HLF-ID-25
假如需要办理，请问印尼有专业服务公司可以协助办理保健食品公司营业许可证？

Evershine RD：

无须申请营业许可证。

HLF-ID-30
外国公司要到印尼销售保健食品，可以指派印尼公司担任营业代理人销售吗?
担任营业代理人，其必要条件是什麽？所需文件及申请程序为何？外国公司与营业代理人的产品责任为何?网页？

If a foreign company wants to sell 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：

需要由在印尼当地的公司申请流通许可证，可以是製造商/进口商/分销商，或委託第三方。

进口商需具备条件：

1. 印尼当地的公司

2. 商业执照

3. 进口商许可证

4. 如为委託第三方机构代理，在申请註册时至少有效期为 3 年

申请流程

1. 线上填写申请表，备妥产品相关证明文件后上传至BPOM电子系统

 网页：http://e-bpom.pom.go.id/

2. 文件审查(人工审查)

3. 合格者发送证号，不合格者退回

4. 每个证号效期为5年，期效届满后可重新申请换发

流通许可证持有公司须负责保健品的安全、品质，及不良事件之处理，并向主管机关回报。

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.

【参考连结】

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

HLF-ID-35

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

Do foreign companies need to apply for an approval before importing 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。需要由在印尼当地的公司申请流通许可证，可以是製造商/进口商/分销商，或委託第三方。

进口商需具备条件：

1. 印尼当地的公司

2. 商业执照

3. 进口商许可证

4. 如为委託第三方机构代理，在申请註册时至少有效期为 3 年

申请流程

1. 线上填写申请表，备妥产品相关证明文件后上传至BPOM电子系统

 网页：http://e-bpom.pom.go.id/

2. 文件审查(人工审查)

3. 合格者发送证号，不合格者退回

4. 每个证号效期为5年，期效届满后可重新申请换发

申请文件

1. 缴税证明

2. 进口商识别号码

3. 委託授权书(如果有)

4. 原产国GMP证书(需取得印尼办事处官印)

5. 自由销售证明(需取得印尼办事处官印)

6. 产品成分表

7. 完成品分析说明、完成品检验分析报告

8. 产品批号意义说明

9. 符合印尼BPOM规格的标籤设计

10.产品检验资料

．质量检测方法和结果，包括原料和成品中有效成分的含量

．印度尼西亚认可实验室的成品质量测试结果

．测试成品质量的结果

．毒性试验和药学试验结果

．以印度尼西亚人体临床试验的耐受性测试结果

．产品副作用报告

．在原产国流通原始产品、包装和标记的样品

．符合法律规定保健品的配送设施

．所有使用的产品储存设施的清单和地址(有一位药剂师负责的证明)

．印花税的声明

．配送设施将接受设施审核(包括增加的设施)

．提交公司账户註册文件和产品註册文件之前的进口商所在地

包装与标示

1. 标示必须直接或牢固地印刷在容器和/或包装上，且不易与包装分离或分离、褪色和损坏。

2. 所含信息必须客观、完整且没有误导性。

3. 须包含警告以及消费者必须考虑的其他事项之信息。

4. 标示必须包括以下信息：

．产品名称

．公司名称、地址

．流通许可证持有人的名称和地址

．尺寸、含量或淨重

．添加剂

．成分

．可用性声明

．使用规则/如何使用

．禁忌症、副作用、警告和注意事项

．许可证号

．批号/生产代码

．保存期限

．储存方法

．清真标籤

．酒精含量

．二维条码

．特殊材料的来源信息

．含有营养物质的，须按照规定在标示中註明每日建议摄取量。

5.未规定的其他信息必须附有支持证据及与安全性、有效性(益处)相关的研究。

6. 初级包装至少需要包含以下资料：

．产品名称

．公司名称、地址

．许可证号

．批号/生产代码

．保存期限

7. 标籤面积小于或等于 10 平方厘米（十平方厘米）的情况下应标示：

．公司名称、地址

．许可证号

8.信息必须使用印度尼西亚语、阿拉伯数字和拉丁字母书写和打印，但产品名称除外，产品名称可以用印尼语以外的语言书写。

9.如果上述的信息是使用印尼语、阿拉伯数字和拉丁字母以外的其他语言打印的，则必须附有与从印度尼西亚宣誓翻译。

10.图像、颜色和/或其他设计可用作背景，只要不掩盖标示。

清真认证程序

1. 产品许可证持有公司向BPJPH书面申请清真认证。BPJPH必须在提交后1个工作日内确认申请文件的完整性。

2.根据申请，指定 LPH 对产品的清真状态进行检查和/或测试。

3. LPH 指定清真审核员进行产品清真检查。在生产过程中对营业场所进行产品清真检查。产品检验过程中，如果有成分怀疑清真性，应在实验室进行检测。

4.清真审核员将产品清真检查结果提交给 LPH。LPH 将结果提交给 MUI，并将副本发送给 BPJPH。

5.产品清真度的确定由 MUI 进行，并在 Halal Fatwa Assembly 中进行。清真产品认定法令（Halal Fatwa）由 MUI 提交给 BPJPH，作为颁发清真证书的依据。

6.如果清真教令大会确定经营者申请的产品为清真产品，BPJPH 应在 1 个工作日内签发清真证书。如果清真法令大会确定产品不是清真产品，BPJPH 将在 1 个工作日内将清真证书申请连同原因退回。

7. 公司必须在申请和註册清真认证程序之前实施清真保证制度( HAS)。清真保证体係以清真政策为基础，建立清真管理团队，编制HAS手册，进行培训，编制相关HAS程序，实施内部审计，正确审查管理。

8. 认证文件

．产品清单

．材料清单和材料文件

．屠夫清单（特别是屠宰场）

．产品矩阵

．HAS 手册

．工艺流程图

．生产设施地址清单

．清真政策传播的证据

．内部培训的证据和内部审计的证据。

9. 註册清真证书（上传数据）

10. 监控清真认证过程的预审核和合同付款

11. 执行审计

12. 执行审计后监控

13. 清真证书有效期为4年

14. 提交清真证书的申请者必须：

．提供正确、清晰和真实的信息

．在清真和非清真产品之间分离加工、储存、包装、分销、销售和展示的位置、场所和设备

．向 BPJPH 报告材料成分的变化

15.获得清真证书的经营者必须：

．在获得清真证书的产品上贴上清真标籤

．保持已获得清真证书的产品的清真

．将清真产品和非清真产品的加工、储存、包装、分销、销售和展示的地点、场所和设备分开

．如果清真证书的有效期已过，须更新清真证书

．向 BPJPH 报告材料成分的变化

16. 清真标籤：经清真认证的产品必须在外包装上标明清真，或未经清真认证的非清真信息。已获得清真证书的经营者必须在以下位置贴上清真标籤：

．产品包装​​

．产品的特定部分

．产品的具体位置

．清真标籤必须易于查看和阅读，并且不易擦除、分离和损坏。

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.

【参考连结】

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

Can a foreign company apply for a 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。需要由在印尼当地的公司申请流通许可证，可以是製造商/进口商/分销商，或委託第三方。

进口商需具备条件：

1. 印尼当地的公司

2. 商业执照

3. 进口商许可证

4. 如为委託第三方机构代理，在申请註册时至少有效期为 3 年

申请流程

1. 线上填写申请表，备妥产品相关证明文件后上传至BPOM电子系统

 网页：http://e-bpom.pom.go.id/

2. 文件审查(人工审查)

3. 合格者发送证号，不合格者退回

4. 每个证号效期为5年，期效届满后可重新申请换发

申请文件

1. 缴税证明

2. 进口商识别号码

3. 委託授权书(如果有)

4. 原产国GMP证书(需取得印尼办事处官印)

5. 自由销售证明(需取得印尼办事处官印)

6. 产品成分表

7. 完成品分析说明、完成品检验分析报告

8. 产品批号意义说明

9. 符合印尼BPOM规格的标籤设计

10.产品检验资料

．质量检测方法和结果，包括原料和成品中有效成分的含量

．印度尼西亚认可实验室的成品质量测试结果

．测试成品质量的结果

．毒性试验和药学试验结果

．以印度尼西亚人体临床试验的耐受性测试结果

．产品副作用报告

．在原产国流通原始产品、包装和标记的样品

．符合法律规定保健品的配送设施

．所有使用的产品储存设施的清单和地址(有一位药剂师负责的证明)

．印花税的声明

．配送设施将接受设施审核(包括增加的设施)

．提交公司账户註册文件和产品註册文件之前的进口商所在地

包装与标示

1. 标示必须直接或牢固地印刷在容器和/或包装上，且不易与包装分离或分离、褪色和损坏。

2. 所含信息必须客观、完整且没有误导性。

3. 须包含警告以及消费者必须考虑的其他事项之信息。

4. 标示必须包括以下信息：

．产品名称

．公司名称、地址

．流通许可证持有人的名称和地址

．尺寸、含量或淨重

．添加剂

．成分

．可用性声明

．使用规则/如何使用

．禁忌症、副作用、警告和注意事项

．许可证号

．批号/生产代码

．保存期限

．储存方法

．清真标籤

．酒精含量

．二维条码

．特殊材料的来源信息

．含有营养物质的，须按照规定在标示中註明每日建议摄取量。

5.未规定的其他信息必须附有支持证据及与安全性、有效性(益处)相关的研究。

6. 初级包装至少需要包含以下资料：

．产品名称

．公司名称、地址

．许可证号

．批号/生产代码

．保存期限

7. 标籤面积小于或等于 10 平方厘米（十平方厘米）的情况下应标示：

．公司名称、地址

．许可证号

8.信息必须使用印度尼西亚语、阿拉伯数字和拉丁字母书写和打印，但产品名称除外，产品名称可以用印尼语以外的语言书写。

9.如果上述的信息是使用印尼语、阿拉伯数字和拉丁字母以外的其他语言打印的，则必须附有与从印度尼西亚宣誓翻译。

10.图像、颜色和/或其他设计可用作背景，只要不掩盖标示。

清真认证程序

1.产品许可证持有公司向BPJPH书面申请清真认证。BPJPH必须在提交后1个工作日内确认申请文件的完整性。

2.根据申请，指定 LPH 对产品的清真状态进行检查和/或测试。

3. LPH 指定清真审核员进行产品清真检查。在生产过程中对营业场所进行产品清真检查。产品检验过程中，如果有成分怀疑清真性，应在实验室进行检测。

4.清真审核员将产品清真检查结果提交给 LPH。LPH 将结果提交给 MUI，并将副本发送给 BPJPH。

5.产品清真度的确定由 MUI 进行，并在 Halal Fatwa Assembly 中进行。清真产品认定法令（Halal Fatwa）由 MUI 提交给 BPJPH，作为颁发清真证书的依据。

6.如果清真教令大会确定经营者申请的产品为清真产品，BPJPH 应在 1 个工作日内签发清真证书。如果清真法令大会确定产品不是清真产品，BPJPH 将在 1 个工作日内将清真证书申请连同原因退回。

7. 公司必须在申请和註册清真认证程序之前实施清真保证制度( HAS)。清真保证体係以清真政策为基础，建立清真管理团队，编制HAS手册，进行培训，编制相关HAS程序，实施内部审计，正确审查管理。

8. 认证文件

．产品清单

．材料清单和材料文件

．屠夫清单（特别是屠宰场）

．产品矩阵

．HAS 手册

．工艺流程图

．生产设施地址清单

．清真政策传播的证据

．内部培训的证据和内部审计的证据。

9. 註册清真证书（上传数据）

10. 监控清真认证过程的预审核和合同付款

11. 执行审计

12. 执行审计后监控

13. 清真证书有效期为4年

14. 提交清真证书的申请者必须：

．提供正确、清晰和真实的信息

．在清真和非清真产品之间分离加工、储存、包装、分销、销售和展示的位置、场所和设备

．向 BPJPH 报告材料成分的变化

15.获得清真证书的经营者必须：

．在获得清真证书的产品上贴上清真标籤

．保持已获得清真证书的产品的清真

．将清真产品和非清真产品的加工、储存、包装、分销、销售和展示的地点、场所和设备分开

．如果清真证书的有效期已过，须更新清真证书

．向 BPJPH 报告材料成分的变化

16. 清真标籤：经清真认证的产品必须在外包装上标明清真，或未经清真认证的非清真信息。已获得清真证书的经营者必须在以下位置贴上清真标籤：

．产品包装​​

．产品的特定部分

．产品的具体位置

．清真标籤必须易于查看和阅读，并且不易擦除、分离和损坏。

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.

【参考连结】

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
经过核准登记的保健食品，进口到印尼要检附什麽文件？经过什麽手续？
在销售时要向各地的卫生福利部相关机构事先或事后准备吗？网页？

What documents are required when importing approved 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：

海关流程

1. 至海关总局註册并取得海关註册编号(NIK)

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

2. 取得进口许可证，有效期为5年，其后可以续期。

3. 进口许可证可透过电子资料联通(EDI)管理，并分为两类：

．一般进口商註册编号(API-U)：适用于普通贸易

．生产型进口商註册编号(API-P) ：适用于进口自用商品的进口商，例如原材料、辅助材料及/或其他用作支援生产过程的产品

4. 填妥进口申报表并向海关总局提交，包含：

．进口申报表

．发票

．包装清单

．提单

．保险保单

．进口关税

．相关税项收据等。

5. 在取得进出口商代码和进口许可证后，进口商应确定并申报进口物品的来源或产地，并遵从清关手续。

6. 计算进口关税率(输入任何进口货物的进口商，应自行评估对此类货物徵收的关税)

7. 须提供资料

．姓名、完整的营业地址

．保存或储存通知货物的场所的情况和描述

．货物的详情

．日期以及收到此类货物的人的姓名和完整地址

．货物所有人的姓名

．货物的名称

．取出货物场所的位置

．通知货物被运往场所的位置

．运输工具(如果使用机动车辆运输通知货物，需填写机动车辆的登记号。）

．运输路线、开始运输的时间日期、可能到达目的地的时间和日期

．销售或转让通知货物的人的姓名和完整的营业地址

．向其出售或转让通知货物的人的姓名和完整地址

．出售或转让的时间和日期

．货物的数量、市场价格

．序列号(如果有)

．批号(如果有)

．专利号(如果有)

．製造商、原产国(如果有)

．品牌(如果有)

．商标(如果有)

8.货物在获准入境前不得从船上卸货

9.仅在批准的地点卸货和装货

10.进口商在出示入境单时应就该入境单的内容的真实性作出并签署声明，并应为支持该声明，向有关官员出示发票（如有）以及可能规定的与进口货物有关的其他文件

11. 入境单的进口商应确保以下事项

．提供信息的准确性和完整性

．任何支持它的文件的真实性和有效性

．遵守本法或当时有效的任何其他法律对货物的限制或禁止

取得流通许可证即可上市，无须销售通知。

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.

【参考连结】

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

HLF-ID-70
印尼保健食品审核机构，需要附上的实验室检验资料有哪些? 网页？

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

Evershine RD：

在印尼，保健品欲申请上市许可需要由政府直接核发或政府授权机构核发的良好生产规范(在申请註册时至少还有 1 年的有效期)，可以是：

1. 良好生产规范 (GMP)

2. 良好的传统药物製造方法（CPOTB）

3. 加工食品良好生产规范 (CPPOB)

对进口保健品申请上市许可，亦要求出示该国政府直接核发或政府授权机构核发的良好生产规范证明，需具备下列其中一项条件

1. 由原产国政府主管部门签发并经印尼地方政府代表官员授权的进口产品

2. 由原产国政府主管部门或政府指定的其他机构签发并经印尼地方政府当地代表官员批准的自由销售证明或药品证明。

产品许可时需要缴交保健品质量要求评估申请表并附上实验是检验资料：

申请表内容

1. 申请人姓名

2. 公司名称

3. 公司地址

4. 联繫人

5. 电话/传真/电子邮件

6.  类别 : 国内/进口/许可证已提交申请)

7. 姓名、签名和公司印章

8. 一般信息

．产品/材料名称

．产品资料

9. 准备表格

．包装

．流通许可证号

．作品

．建议用途

．建议使用规则

10.註册人

．註册人姓名

．註册人地址

11. 製造商

．生产商名称

．製造商地址

12 如果具备许可证

． 许可人名称

． 许可人地址

．特别信息

13. 用作保健品的历史

14. 标准药典专着

15. 各国监管状况

16. 支持材料/产品安全的数据（毒性测试结果、国际安全状态，例如 JECFA、GRAS）

17. 支持材料/产品效益的数据（已进行、发表的研究结果）

18. 其他证明文件（如果需要）

19. 活性成分表

．名称

．印度尼西亚语

．CAS 编号*

．同义词 *

．功能

．分子量

．常用剂量

．最高限额

．参考数目

．AKG / ALG

实验室检验数据

1. 授权的实验室

2. 具有良好生产规范证书的工业实验室

需要具备测试参数包括：

1. 物理参数

．外观

．硬度/脆性

．崩解时间

．黏度

．酸硷度

．颗粒/颗粒大小

．可重悬性

．附着力（黏合强度）

2. 化学参数

．速率频率

．含水量

3. 微生物参数

．微生物汙染

4. 重金属汙染

5. 酒精含量的测定

6. 比重和 pH 值

7. 活性成分的鑑定

8. 活性成分的测定等

9. 可以对包含某些利益声明的成品进行定性鑑定

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

【参考连结】

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

HLF-ID-75

HLF-ID-77

HLF-ID-80
外国子公司进口保健食品后，如果委託印尼的经销商销售，经销商需要保健食品营业许可证吗？
假如保健食品有品质瑕疵的话，外国子公司和经销商各自的责任为何？是连带责任吗？还是可以规范由外国子公司负责？

After a foreign subsidiary imports 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：

无须申请营业许可证。流通许可证持有公司须负责保健品的安全、品质，及不良事件之处理，并向主管机关回报。

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.

【参考连结】

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

HLF-ID-85

各国健康食品登记法规问题集

联繫我们
Email：jkt4ww@evershinecpa.com
或
印尼永辉BPO有限公司
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The Engaging Manager Cindy Luo, Indonesia citizenship, speak English, Bahasa and Chinese
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