Exporting Consumer Health Products to Indonesia...BPOM’s Definitions of Products • Traditional Medicine is an ingredient or mixture of ingredients in the form of plant material,

Exporting Consumer Health

Products to Indonesia

Tapping Indonesia’s growing consumer health industry

Thursday, 28 August 2014

Shannon Leahy Trade Commissioner Austrade Jakarta

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Agenda

Austrade: Who we are and what we do

Market overview of consumer health products in

Indonesia

Regulatory environment in Indonesia

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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.

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Where we operate - a global network

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international markets

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• Identification of relevant international contacts

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international business opportunities

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• www.austrade.gov.au/export

http://www.austrade.gov.au/export

Updated September 2014

Indonesia Market Overview

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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

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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

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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

Consumer Health Industry in Indonesia

Feranica Susanto

Business Development Manager

Austrade Jakarta

Updated 4 March 2014

Australia Unlimited

Overview

the increasingly busy lifestyle of Indonesian

consumers

unfavourable weather the unseasonal

weather conditions

aggressive marketing efforts by leading

manufacturers

Spending on consumer health products

continued to grow in 2013.

Contributing heavily to the growth are:

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Overview

*Source: Euromonitor

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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

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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)

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Opportunities

Food supplements to boost immunity and prevent illness

Middle Class

Urbanites

Senior citizens

Children

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Distribution Channels

Pharmaceutical channels

• Modern pharmacy chains

• Local pharmacies (‘apotik’)

Retail channels

• Hypermarkets / supermarkets

• Traditional markets

Registration Process and Regulations

Arfadh Baparsyah


Austrade Jakarta

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Regulatory body

Badan Pengawas Obat dan Makanan (BPOM) Republik Indonesia

Indonesian National Agency for Drug & Food Control (NA-DFC)

www.pom.go.id

http://www.pom.go.id/

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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

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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.

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• 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.


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• 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.


Food Supplements

Registration Process and Regulations

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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

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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

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Technical Documents

• Formula

– Composition: Active ingredients and additive, in matrix

– Direction of use: Direction, dosage, warning, precaution,

contraindication / recommendation, and duration of

administration, if any

• Quality and Technology

– Manufacturing process: From weighing of raw materials to

finished products

– Method and result of stability study

* Zone IV, RH: 75% 5%, T: 30C 2 C, min. 6 months, min. 2 batch

*All documents must be from the manufacturer / country of origin

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Technical Documents - Additional

• Additional documents:

– Certificate of Safety Test from laboratories appointed by BPOM

for: organoleptic, physical-chemical, microbial, heavy metal,

chemical drug, and psychotropic-narcotic contaminant

– Data of Toxicity Test from laboratories appointed by BPOM or

equivalent body in country of origin for food supplements which

its safety is not yet known.

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Labelling Requirements

Labels must be in Bahasa Indonesia and must include:

• The word: ‘Food Supplement’

• Product Name

• Net Weight / Net Volume

• Name and Address of Manufacturer

• Name and Address of Importer

• Indication, direction of use, and serving size

• Composition / ingredients, qualitative and quantitative

• Energy value per serving in calories (for energy drinks)

• Alcohol content for oral solution, if any

• Expiry date, production code, and registration number

• Contraindication, side effects, and warning, if any

• Other information related to safety, quality, or source of materials according to provision

*Labels does not have to be applied prior to shipment (in country of origin). They can be applied in destination country before being distributed in the market

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Halal Requirement

• BPOM does not require imported products to be labelled HALAL. However,

– Products containing certain substances originating from pig* must include a writing sign ‘MENGANDUNG BABI’ – means containing pig substances – in black font in a black box on a white base in the label.

– Special sign of ‘PADA PROSES PEMBUATANNYA BERSINGGUNGAN DENGAN BAHAN BERSUMBER BABI’ – means during production process, contacts with substances originating from pig occurred - in black font in a black box on a white base in the label is necessary if such process involved.

– Products containing alcohol must state its alcohol contain in percentage form at the label.

– Texts must be clearly readable and is proportional to the size of the label.

*Substances may be in the form of gelatine, glycerine, enzyme, fat, collagen, colostrums, embryo extract, blood extract, hydrolized hemoglobin, keratin, hair extract, placenta, protein, thymus extract, thymus hydrolized, stomach extract, oil, shortening, thickener, emulsifier, stabilizer, l-systein, monoglyceride, diglyceride, or triglyceride.

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Additional Requirements

• Importers must have Import Information Letter (SKI)

issued by Head of BPOM – valid for one-time

importation.

• Food Supplement must have a remaining shelf life of at

least 1/3 of the stated shelf life.

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BPOM’s Regulations on Food Supplements

• Regulation Number 27 Year 2013 Concerning Importation Control Of Drug And Food Into The

Territory Of Indonesia

• Regulation Number 28 Year 2013 Concerning Importation Control Of Drug Material, Traditional

Medicine Material, Health Supplement Material, And Food Material Into The Territory Of Indonesia

• HK.03.1.23.06.10.5166 Year 2010 on Inclusion of the information on certain substances, alcohol

contain and expired time on the label of medicine, traditional medicine, supplement food, and food

• HK.00.05.41.1381 Year 2005 on Procedures of Foods Supplement Registration

• HK.00.05.23.3644 Year 2004 on Basic Provisions of Food Supplement Control

• HK.00.05.42.6575 Year 2007 on Prohibition from using Benzyl Piperazine in Food Supplements

• HK.00.1.23.05.12.3428 Year 2012 on Prohibition from Producing and Circulating Traditional

Medicine and Food Supplement Containing Pausinystalia Yohimbe Plants

For more info: www.pom.go.id

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Questions & Answers from participants

Q :

What Australian consumer products are currently on the

shelves in Indonesia? Particularly in the health supplements

sector?

A :

• Australian food supplements: Nature’s Care

• Nature’s care products available: Omega, Royal Propolis

• Market dominated by US : Nature’s Plus (US), Nature’s

Bounty (US), GNC (US), and Hezzel Farm (Canada)

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Questions & Answers from participants

Q:

What makes Australian products attractive to Indonesian market?

what is their competitive edge?

A :

• Australian accreditation standards: TGA, Australian Certified

Organic and ECO certified, cGMP

• Australia’s healthy lifestyle perception – more than 200,000

Australian alumni in Indonesia who are aware of lifestyle

• Testimonials from other ASEAN countries assist in marketing

• Regular market visits and promotional activity support are

crucial in a long term commitment with local partner

For further information,

please contact:

Arfadh Baparsyah,


[email protected]

Feranica Susanto


[email protected]
mailto:[email protected]:[email protected]