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Food supplement registration in indonesia

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Find out how to register food supplement products in Indonesia

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Food supplement registration in indonesia

  1. 1. Food Supplement Product Registration in Indonesia Vitafoods Asia Hong Kong, September 2016
  2. 2. Contents Background of Food Supplement in Indonesia Food Supplement Regulations Company Profile 2 Food Supplement Product Registration Requirements of Food Supplement Registration
  3. 3. What is Food Supplement in Indonesia? According to the BPOM (National Agency of Drug and Food Control in Indonesia), food supplement is • products that are intended to supply the nutritional needs, • maintain, enhance and improve health functioning, • contain one or more ingredients such as vitamins, minerals, amino acids or other materials (derived from plant or not plant) that has nutritional value and / or physiological effects, • that are not intended as food. 3
  4. 4. Contents Background of Food Supplement in Indonesia Food Supplement Regulations Company Profile 4 Food Supplement Product Registration Requirements of Food Supplement Registration
  5. 5. 5 Food Supplement Regulations Main regulations issued by the Head of BPOM regarding food supplements: • Number 27 Year 2013 : Control of Food and Drug Entry in to Indonesia • Number HK.03.1.23.06.10.5166 : Inclusion of Information of Certain Materials of Origin, Content of Alcohol, and Expiration Date on the Label of Drug, Food Supplement, and Food • Number HK.00.05.41.1381 : Procedures of Food Supplement Registration • Number HK.00.05.23.3644 : Provisions of Food Supplement Control
  6. 6. 6 Import Regulations • BPOM regulations Number 27 Year 2013 regarding The Control of Food and Drug Entry in to Indonesia, stating that for all food and drug, includes food supplement entering Indonesia shall possess: – Product license – Fulfill prevailing import law – Obtain approval from the Head of BPOM for Import Notification Letter (SKI) that is valid for one-time of importation. • There is no formal import barrier on food supplement. The import duty for food supplement is 10 % plus 10 % VAT. The rates are lower for 0 - 5 % for products originating in ASEAN FTA members. .
  7. 7. 7 Halal Certification • Halal certificate is issued by the Indonesian Council of Ulama (MUI) based on assessment conducted by the Assessment Institute for Foods, Drugs, and Cosmetics The Indonesian Council of Ulama (LPPOM MUI). • Government bodies responsible for food controlling: – Ministry of Agriculture for meat and animal based foods – National Agency for food and drug control (BPOM) for food packaged product • According to the regulations, it is mandatory to have Halal certification for food supplement, however it has not been implemented yet until now and planning to be implemented by the year of 2017 or 2018. .
  8. 8. Contents Background of Food Supplement in Indonesia Food Supplement Regulations Company Profile 8 Food Supplement Product Registration Requirements of Food Supplement Registration
  9. 9. Food Supplement Registration Overview • The National Agency of Drug and Food Control (Indonesian acronym BPOM) is responsible to regulate and control the registration, distribution, and quality of food supplement. • All food supplement products shall be registered at BPOM to obtain registration number of food supplement product to be able to be distributed legally in Indonesia. • The food supplement products shall be registered under Indonesian company, as distributor or agent in Indonesia (it is not allowed to be registered by foreign company or individual). 9
  10. 10. • The product license is valid for 5 years only under 1 company. Meaning that after registration, this company will receive some kind of exclusivity on the products, since this company holds the product license and without their approval, the principal or exporter is not able to change the company or make any registration under the other distributor. • Food supplement registration in Indonesia takes around 3 - 6 months. The registration lifetime of food supplement is valid until 5 years as long as it is still meeting the prevailing provisions and extendable through re-registration of food supplement product. 10 Food Supplement Registration Timeframe
  11. 11. Products Registered at BPOM by end of July 2016 11 7 days ago From 201630 days ago Food & Beverage Food Supplement Cosmetics Traditional Drug Food Supplement Drug
  12. 12. 12 Food Supplement Registration Process – Legal Entity Registration Fill out legal entity online registration form 1 Verification process2 Facility inspection to the office and warehouse 3 4 5Submit legal entity documents and inspection report to BPOM Data verification by BPOM Returned to be corrected or completed 6bUser ID and password provided by email IncompleteComplete 6a
  13. 13. 13 Food Supplement Registration Process – Product Registration Fill out product online registration form 1 Submit product documents to BPOM 2 Pre-registration payment to BPOM 3 Verification of pre-registration payment 4 Pre-registration process Request for additional data 6bRegistration payment to BPOM 6a 5 IncompleteComplete Verification of registration payment 7 Evaluation of registration process 8 Product registration number issued Letter requesting additional data Rejection letter 9b 9c 9a Rejected Incomplete Approved
  14. 14. Contents Background of Food Supplement in Indonesia Food Supplement Regulations Company Profile 14 Food Supplement Product Registration Requirements of Food Supplement Registration
  15. 15. 15 Registration Requirements – Company documents • Article of Association and its’ amendments • Deed of Establishment and its’ amendments • Domicile letter • Tax ID • Business License – stating food supplement trading • Company Registration Certificate • Import License – which covers food supplement product
  16. 16. 16 Registration Requirements – Product Documents • Letter of Authorization (LoA) – from Principal to Distributor or Agent, shall be legalized by Indonesian Embassy in the origin country • Certificate of Free Sales (CFS) from origin country – legalized by Indonesian Embassy in the origin country • Good Manufacturing Procedure (GMP) • Relationship Letter – if the Principal is different with the Manufacturer • Certificate of Analysis of finished product – with detail % of each ingredients • Certificate of Analysis of each raw materials • Safety test certificate from authorized laboratory in Indonesia • Toxicity test, if the product safety is unknown
  17. 17. 17 Registration Requirements – Labelling The label should includes points in the following: • Word : Food Supplement (in Indonesian is “Suplemen Makanan”) • Product name • Net weight or net volume • Name and address of manufacturer or importer • Indication, direction of use and serving size / dosage • Composition / ingredients in qualitative and quantitative • Energy value per serving (in calorie) for energy drink product • Alcohol content for oral solution, if any • Expiry date, production code, and registration number • Contraindication, side effect, and warning, if any • Other information related to safety or quality or source of material according to the provisions • Label shall be mentioned in Bahasa Indonesia language.
  18. 18. Contents Background of Food Supplement in Indonesia Food Supplement Regulations Company Profile 18 Food Supplement Product Registration Requirements of Food Supplement Registration
  19. 19. 19 Our Vision To be leading consulting firm of business services to clients expanding and operating in Indonesia. Our Mission To provide full-range of market-entry and corporate services to enable our clients to focus on their core business and activities in Indonesia and beyond. PT. Cekindo Bisnis Grup is a leading consulting firm of Market-Entry and Corporate secretarial services to clients expanding and operating in Indonesia and further to Southeast Asia. Our Values Client-focused Excellence performance Knowledgable locally Integrity moral Normative operations standards Delivered on-time One stop services provider Company Profile
  20. 20. 20 Our main services: Business Set Up Business Process Outsourcing Local Representation  Company Registration  License & Product Registration  Market Research & Analysis  Local Partner Selection  Trade Mission  Land & Property Ownership  Recruitment & HR Establishment  Payroll Management  Accounting & Tax Reporting  Visa & Work Permit  Mystery Shopping  Local Distributor & Partner  Buying Agent  Office Space Cekindo Services
  21. 21. 21 Senior Advisor Prof. Dr. Rahardi Ramelan Relevant Experience Mr. Ramelan is currently Senior Advisor at PT Cekindo Bisnis Grup. Hi is a Research Professor at the Agency for the Assessment and Application of Technology. The honorary degree of Doctor Honoris Causa from Monash University, Australia and Northeastern University Boston.  Minister of State for Research and Technology of the Republic of Indonesia and Chairman of the Agency for Assessment and Application of Technology (BPPT) in the Seventh Development Cabinet of the Republic of Indonesia.  Minister of Industry and Trade in the Development Reforms Cabinet of the Republic of Indonesia and Chairman of National Logistic Agency.  Deputy Chairman for Industrial Analysis and Vice Chairman of the National Development Planning Agency of the Republic of Indonesia  Several management positions and responsibilities related to Indonesian Aviation industry, the Weapon industry. Prof. Dr. Rahardi Ramelan Profile Overview
  22. 22. 22 Principal Consultant Michal Wasserbauer Michal is currently Principal Consultant at PT Cekindo Bisnis Grup. He has more than 5 year‘s experience in the Corporate Market research, Strategy and Evaluation Expansions, Business Consultancy, and Preparation of Business Feasibility Studies. He has worked for various industries, namely Grocery and Marchandise Retail, Energy, Medical Device, Heavy and Automation Industries. +6281282300584 |  michal.wasserbauer@cekindo.com Michal Wasserbauer  Market opportunities valuation  Investment analysis  Performance management  Feasibility studies  Strategy planning  Stakeholder management  Marketing consultancy Profile Overview Relevant Experience Relevant Skills  Multinational grocery and general merchandise retailer: Capital Investment Appraisals  World‘s largest student and recent graduates-run organisation: Financial Controller  International consultation company: Market Expansion Consultant
  23. 23. 23 Principal Consultant Nurmia Agustina Nurmia is currently Principal Consultant at PT Cekindo Bisnis Grup. She has wide experience in the areas of Business Development, Legal Corporate Restrictions, Business Consulting, Project Management, Market Development & Entry Strategy, Sales & Distribution, Management Strategy, Recruitment, Visa & Work Permit, and Change Management. She has worked for various industries, namely Energy & Resources, Telecommunication, Retail, Pharmaceutical & Medical, Financing, Non-Profit, IT and Heavy Industries. +628119691987 | nurmia.agustina@cekindo.com  International Management company: Management & Legal consultant  Chamber of Commercial: Head of Business Processing Section Nurmia Dwi Agustina  Corporate law  Outsourcing processes  Company formation  Acquisitions  Project Management  Competitive Analysis  Business Planning  Risk Management  Talent Management Strategy  Recruitment  Visa & Work Permit  Change Management Relevant Experience Relevant Skills Profile Overview
  24. 24. 24 Selected Clients
  25. 25. PT. Cekindo Bisnis Grup Menara BCA Grand Indonesia 50th floor Jl. MH. Thamrin No. 1 Jakarta Pusat - 10310 Indonesia  info@cekindo.com  +6221 80660999

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