food supplement registration in indonesia
Post on 16-Apr-2017
246 Views
Preview:
TRANSCRIPT
Food Supplement Product Registration in Indonesia
Vitafoods AsiaHong Kong, September 2016
2
Contents
Background of Food Supplement in Indonesia
Food Supplement Regulations
Company Profile
Food Supplement Product Registration
Requirements of Food Supplement Registration
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.
4
Contents
Background of Food Supplement in Indonesia
Food Supplement Regulations
Company Profile
Food Supplement Product Registration
Requirements of Food Supplement Registration
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
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
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
Contents
Background of Food Supplement in Indonesia
Food Supplement Regulations
Company Profile
Food Supplement Product Registration
Requirements of Food Supplement Registration
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).
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.
Food Supplement Registration Timeframe
11
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
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
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
5IncompleteComplete
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
Contents
Background of Food Supplement in Indonesia
Food Supplement Regulations
Company Profile
14
Food Supplement Product Registration
Requirements of Food Supplement Registration
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
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
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
Contents
Background of Food Supplement in Indonesia
Food Supplement Regulations
Company Profile
Food Supplement Product Registration
Requirements of Food Supplement Registration
19
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
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
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
22
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 | michal.wasserbauer@cekindo.com
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
23
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 | nurmia.agustina@cekindo.com
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
24
Selected Clients
PT. Cekindo Bisnis Grup
Menara BCA Grand Indonesia 50th floorJl. MH. Thamrin No. 1Jakarta Pusat - 10310Indonesia
info@cekindo.com +6221 80660999
top related