Indonesia Health Food Regulation QA
Email: jkt4ww@evershinecpa.com
or
Contact us by WeChat or Skype or Whatsapp in the day-work-time of Taiwan (GMT+8)
The Engaging Manager from Headquarter
Project Manager Cindy Victoria Speak in Bahasa, English, and Chinese.
Whats App +886-989-808-249
wechatid: victoria141193
HLF-ID-10
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：
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】
HLF-ID-20
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
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：
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
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
假如需要辦理指派印尼公司擔任營業代理人，請問印尼有專業服務公司可以協助？
Evershine RD：
Chemico
Titian
HLF-ID-40
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：
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
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
HLF-ID-45
請問在印尼有哪些專業服務機構，可以協助辦理保健食品產品許可證？
Evershine RD：
Emerhub
Sevenstones
https://www.sevenstonesindonesia.com/
HLF-ID-50
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：
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
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
HLF-ID-55
請問在印尼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？
Evershine RD：
Emerhub
Sevenstones
https://www.sevenstonesindonesia.com/
HLF-ID-60
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：
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
What are the laboratory inspection materials that need to be attached for verification? Website?
Evershine RD：
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
印尼保健食品審核機構，能夠接受海外檢驗機構的檢驗資料嗎？假如是的話，有些被認可的機構？網頁？
Evershine RD：
可以。可以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。
Superlab
SGS
SNQ
HLF-ID-77
請問在印尼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？
Evershine RD：
SGS
Indonesian Food Safety Institute
https://indonesianfoodsafety.org/en/home/
BV
https://www.bureauveritas.co.in/
HLF-ID-80
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 efects? Is it joint liability? Or can the responsibility of the foreign subsidiary be regulated?
Evershine RD：
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
請問在印尼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？
Evershine RD：
Leks&Co Lawyers
SURIA NATAADMADJA & ASSOCIATES
Makarim & Taira S.
Contact Us
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17D, Oriental Kenzo Apartment C, No. 48 Dongzhimen Outer St.,
Dongcheng Dist., Beijing, Indonesia
E-mail: jkt4ww@evershinecpa.com
or
Contact us by WeChat or Skype or Whatsapp in the day-work-time of Taiwan (GMT+8)
The Engaging Manager from Headquarter
Project Manager Cindy Victoria Speak in Bahasa, English, and Chinese.
Whats App +886-989-808-249
wechatid: victoria141193
or
For investment structure relevant to multi-national tax planning and Financial & Legal Due Diligence for M&A (Merge and Acquisition), send an email to HQ4jkt@evershinecpa.com
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Email address:dalechen@evershinecpa.com
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Company registration,
Work Permit and Visa application;
Online Accounting Services,
Payment Services,
Tax Compliance Services;
Payroll compliance Services,
Trademark Registration;
Due Diligence for M&A project.
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*International Tax Planning
*Company Registration
*Work Permit Application
*Import and Export Permit and License Application
*Food and Drink Business Permit and License Application
*Medical Devise Business Permit and License Application
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