Food supplement registration in indonesia

Food Supplement Product Registration in Indonesia

Vitafoods AsiaHong Kong, September 2016

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Contents

Background of Food Supplement in Indonesia

Food Supplement Regulations

Company Profile

Food Supplement Product Registration

Requirements of Food Supplement Registration

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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.

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Contents



Company Profile



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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

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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.

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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.

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Company Profile



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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).

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• 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.

Food Supplement Registration Timeframe

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Products Registered at BPOM by end of July 2016

7 days ago From 201630 days ago

Food & Beverage

Food Supplement

Cosmetics

Traditional Drug Food Supplement

Drug

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Food Supplement Registration Process – Legal Entity Registration

Fill out legal entity online registration form

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Verification process2

Facility inspection to the office and warehouse

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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

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Food Supplement Registration Process – Product Registration

Fill out product online registration form

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Submit product documents to BPOM

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Pre-registration payment to BPOM

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Verification of pre-registration payment

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Pre-registration process

Request for additional data

6bRegistration payment to BPOM

6a

5IncompleteComplete

Verification of registration payment

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Evaluation of registration process

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Product registration number issued

Letter requesting additional data

Rejection letter

9b

9c

9a

Rejected

Incomplete

Approved

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Company Profile

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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

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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

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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.

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Contents



Company Profile



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Our VisionTo 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 ValuesClient-focusedExcellence performanceKnowledgable locallyIntegrity moralNormative operations standardsDelivered on-timeOne stop services provider

Company Profile

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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

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Senior AdvisorProf. 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

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Principal ConsultantMichal 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 | [email protected]

Michal Wasserbauer

Market opportunities valuation Investment analysisPerformance management Feasibility studies

Strategy planningStakeholder managementMarketing 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

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Principal ConsultantNurmia 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 | [email protected]

International Management company: Management & Legal consultant

Chamber of Commercial: Head of Business Processing Section

Nurmia Dwi Agustina

Corporate lawOutsourcing processesCompany formationAcquisitionsProject ManagementCompetitive Analysis

Business PlanningRisk ManagementTalent Management StrategyRecruitmentVisa & Work PermitChange Management

Relevant Experience

Relevant Skills

Profile Overview

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Selected Clients

PT. Cekindo Bisnis Grup

Menara BCA Grand Indonesia 50th floorJl. MH. Thamrin No. 1Jakarta Pusat - 10310Indonesia

[email protected] +6221 80660999