Exporting Consumer Health Products to Indonesia Tapping Indonesia’s growing consumer health industry Thursday, 28 August 2014 Shannon Leahy Trade Commissioner Austrade Jakarta
Agenda Austrade: Who we are and what we do Market overview of consumer health products in Indonesia Regulatory environment in Indonesia Australia Unlimited
Austrade – who we are The Australian Trade Commission – Austrade – contributes to Australia's economic prosperity by helping Australian businesses, education institutions, tourism operators, governments and citizens as they: • develop international markets • win productive foreign direct investment • promote international education • strengthen Australia's tourism industry • seek consular and passport services. Australia Unlimited
Where we operate - a global network Australia Unlimited
Services for Australian businesses • Information and advice on doing business in international markets • Help with international market selection • Identification of relevant international contacts • Assistance with market entry and expansion • Identification and follow-up of specific international business opportunities Australia Unlimited
Online resources – austrade.gov.au • Assess your export readiness using Austrade’s International Readiness Indicator • Market profiles – more than 84 country/export market profiles • Find out about events in Australia and overseas • Australian Suppliers Database – join over 10,000 Australian companies in this directory accessed by potential customers throughout the world - listing is free of charge • Export Update – subscribe to a free monthly newsletter to receive the latest in export news and events • www.austrade.gov.au/export Australia Unlimited
Indonesia Market Overview Updated September 2014
Indonesia at a glance • Indonesia is the 4th most populous nation in the world • >50% Population under age of 30 • GDP growth - 5.6% in 2013 * Source : RSM AAJ, KPMG, DFAT Australia Unlimited
What makes Indonesia attractive? • Indonesia’s ‘consuming’ class numbers 45 million forecast to increase to 135 million by 2030. • Indonesia projected to be world’s 7th largest economy by 2030. • Rising regional investment particularly from Japan and Korea Australia Unlimited
Tips to doing business in Indonesia • Participate regularly in major local trade exhibitions • Long term commitment to market • Local partner(s) (distributor / importer) is crucial • Price, payment terms, and after sales service • Product registration, comply with local regulations • Build and maintain good relationships Australia Unlimited
Consumer Health Industry in Indonesia Feranica Susanto Business Development Manager Austrade Jakarta Updated 4 March 2014
Overview Spending on consumer health products continued to grow in 2013. Contributing heavily to the growth are: the increasingly busy lifestyle of Indonesian consumers unfavourable weather the unseasonal weather conditions aggressive marketing efforts by leading manufacturers Australia Unlimited
Overview * Source: Euromonitor Australia Unlimited
2013 Trend Highlights • Multivitamins still lead market in volume sales • Traditional medicines remain popular • Growing health awareness among younger middle-to high-income consumers • Increasing use of social media in marketing Australia Unlimited
Competitive Environment • Functional foods and drinks as substitutes for vitamins and supplements • Locally manufactured traditional medicines / herbal products (JAMU) • Generic drugs, vitamins, and supplements produced by local manufacturers for cough, cold, allergy (hay fever) • New diet programs and slimming clinics • Recently introduced Universal Social Security System (BPJS) Australia Unlimited
Opportunities Food supplements to boost immunity and prevent illness Middle Senior Children Class citizens Urbanites Australia Unlimited
Distribution Channels Pharmaceutical channels • Modern pharmacy chains • Local pharmacies (‘ apotik ’) Retail channels • Hypermarkets / supermarkets • Traditional markets Australia Unlimited
Registration Process and Regulations Arfadh Baparsyah Business Development Manager Austrade Jakarta
Regulatory body Badan Pengawas Obat dan Makanan ( BPOM ) Republik Indonesia Indonesian National Agency for Drug & Food Control (NA-DFC) www.pom.go.id Australia Unlimited
BPOM’s Registration Units Directorate of Drug and Biological Product Evaluation Directorate of Traditional Medicines, Cosmetics, and Food Supplements Evaluation Directorate of Food Safety Evaluation Australia Unlimited
BPOM’s Definitions of Products • Drug is finished drug including biological product that is an ingredient or mixture of ingredients utilized for affecting/examining physiological system or pathological condition in order to determine diagnosis, prevention, treatment, recovery and improvement of health and contraception for human. • Biological Product is vaccine, antibody, antigen, hormone, enzyme, blood product and other fermentation product (including monoclonal antibodies and product originating from DNA recombinant technology) utilized to affect/inspect physiological system or pathological condition in order to prevent, treat, recover and improve health. Classification of product is not necessarily defined by BPOM definitions, but more to the ingredients contained instead. Two similar products may need to undergo different registration process according to the ingredients contained. Australia Unlimited
BPOM’s Definitions of Products • Traditional Medicine is an ingredient or mixture of ingredients in the form of plant material, animal material, mineral material, essence preparation, or mixture of those materials which for generations has been used for medication, and can be implemented according to public norms. • Quasi Medicine is medicine with active ingredients with pharmacological effect for minor complaints. • Cosmetics is ingredient or preparation intended for used on the outer human body (epidermis, hair, nail, lips and outer genital organ) or teeth and mucous membrane in the mouth specifically to clean, perfume, alter the appearance and or improve body odor or protect or maintain the body in good condition. • Food Supplement is product that is meant to complement the nutritional need, maintain, increase and improve health function, containing one or more ingredients in the form of vitamin, mineral, amino acid or other ingredient (originating from plant or non-plant) that have nutritional value and/or physiological effect, not intended as food. Classification of product is not necessarily defined by BPOM definitions, but more to the ingredients contained instead. Two similar products may need to undergo different registration process according to the ingredients contained. Australia Unlimited
BPOM’s Definitions of Products • Food is everything coming from biological resources and water, whether processed or not, designated as food or drink for human consumption, including food supplement, food raw material and other materials used in the process of preparation, processing and/or production of food or beverage. • Processed Food is food or beverage resulting from a process in a certain way or method with or without added ingredient. • Functional food is processed-food containing one functional component or more, which based on scientific analysis has certain physiological functions, is proven not dangerous and beneficial to health. Classification of product is not necessarily defined by BPOM definitions, but more to the ingredients contained instead. Two similar products may need to undergo different registration process according to the ingredients contained. Australia Unlimited
Food Supplements Registration Process and Regulations
Registration Fees and Timeframes Registration is conducted in 2 stages, pre-assessment and assessment • Pre-assessment – Processing time: 20 working days – Fee: IDR 50,000 (AUD 5) per product item* – Additional 10 working days for each Pre-assessment Variation (change of product details) • Assessment – Processing time: 60 working days – Fee: IDR 10,000,000 (AUD 1000) per product item* Note: – Processing time might be prolonged if further test results / documents are required – Pre-assessment and assessment process might result in REFUSAL. In such case, applicants are allowed to re-register (pre-assessment stage) or appeal (assessment stage). Fees paid remain non-refundable. – Different sizing/packaging of the same product item is considered as one, hence only one registration is required Australia Unlimited
Administration Documents • Certificate of Manufacturer licensed for TMs or pharmaceuticals; or Certificate of Importer licensed for TMs or pharmaceuticals • Import License (API) from the importer • Letter of Authorization from the manufacturer • Certificate of Free Sale (CFS) issued by the Government of country of origin, legalised by the Indonesian Embassy / Consulate General • Good Manufacturing Practice (GMP) from the manufacturer Australia Unlimited
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