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- NPRA(National Pharmaceutical Regulatory Agency) Product Registration Services
Named FDA (Indonesian: Badan Pengawas Obat and Makanan) or Badan POM (BPOM) which refers to the Indonesian Food and Drug Administration is a branch of government institutions and liable for the safety of public health. This regulatory and executive body performs the monitoring of pharmaceutical and over-the-counter medicinal drugs (medications), vaccines, specialty chemicals, food supplements, food standards, herbal medicine, and cosmetic products that will be approved, sold, and distributed in Indonesia including the permissions to be given to imported products of abovementioned categories.
What Do You Need To Do with BPOM if You Want to Sell Your Goods to Indonesia?
Law No 27 of 2013 on the control of imports of drugs and foodstuffs into the territory of Indonesia, which entered into force on 28 May 2013 applies to all drug, cosmetics, and food products. This law is indeed all exclusive to current implementations and regulations which means that previous ones are no longer valid.
In addition to the delivery authorization (izin edar) and other applicable conditions under the current import legislation, wholesalers of drugs and food require the permission of the Head of BPOM. This condition also extends to imports into free trade zones and free ports.
Imported goods shall comply with the following storage prerequisites:
- There should be at least 1/3 of the shelf life of medications, alternative remedies, nutritional supplements, and cosmetics,
- There should be at least 9 months before the date of expiry for agricultural products,
- At least 2/3 of the shelf life for packaged food should be provided.
Procedure for Registration in BPOM website
The Legislation implements an online process from the Head of BPOM for qualifying for a SKI. To obtain a user ID and password, candidates should first enroll on the BPOM official site by uploading an online application form with the necessary supporting documentation.
For Importing Goods to Indonesia
In general, the SKI application is submitted online followed by electronic documentation (pdf file) containing the necessary relevant documentation, including:
- the approval of the shipment license
- the analysis documents
- the billing documents
- the packaging lists
- the billing documents of Shipment or if airway invoice if it is the case
- the document proving that non-tax State Revenue has been paid (Penerimaan Negara Bukan Pajak).
For Importing Vaccines to Indonesia
The application for a SKI for vaccines must also be followed by (a) the shipment clearance registration certificate by the approved institution of the exporter, and (b) the batch/lot overview checklist provided by the manufacturer. The BPOM can further assess and measure the vaccine's content.
For Importing Generic Drugs and Over the Counter
The product name indicated on the invoice must be the same as that indicated on the Distribution License for SKI for generic medications, quasi-drugs, cosmetic and beauty products, and dietary supplements. SKI applications for cosmetics may, if the manufacturer submits a declaration, be excluded from this requirement.
For Importing Packaged Foods to Indonesia
SKI applications for packaged food often have to comply with such conditions set down in the legislation, namely:
- An Authorized mark at the point of registration.
- A Declaration from the manufacturer, where the exporter and the producer are separate parties, or where the import documentation and the delivery license do not include the same name of the packaged food.
- A letter of advice from the Minister of Agriculture for processed foods derived from animals.
- Any other required accreditations under the legal requirements (if any).
Latest Update on Achieving SKI online in 2020
As part of new efforts, BPOM Regulation No. 8 of 2020 on the Supervision of the Online Delivery of Food and Drugs ('Reg. 8/2020') has recently been released by the National Agency for Food and Drug Control ('BPOM'), which seeks to protect the public by setting down ground rules for the online distribution of pharmaceutical products, conventional medicinal products, dietary additives, cosmetic, processed foods and foodstuffs.
Reg. 8/2020 describes the "online food distribution and drugs" as any operation or sequence of activities related to the distribution of any of the above-listed items through electronic trading and sets out the criteria that should be met for the digital distribution of each type of product, including the need to obtain a delivery and distribution authorization for each particular product.
Online Supply of Medicines and FSMP
Pursuant to Reg. 8/2020, internet delivery of medical drugs and FSMP can be carried out only by approved pharmacies who may comply with suppliers of pharmaceutical electronics (ESP). The legislation lays out the duty of hospitals and pharmacy ESPs to distribute their products electronically, including the duty to check prescriptions and drug conditions, and to keep records.
Pharmacies and pharmacy ESPs are not allowed to sell the following medicines:
- Drugs that contain a pharmaceutical precursor.
- Medicines for Erectile Dysfunction.
- Injecting supplies, rather than insulin.
- Provision of implants, the use of which includes assistance from health care practitioners and Pain killers and psychotropic drugs
The sale of medicines and FSMP via social media, regular sales, and classified advertising is also expressly banned.
If You are a Foreign Company that Wants to Sell Drugs, Medicines, and Cosmetics to Indonesia
If you are a foreign company starting a business in Indonesia or wish to ship to Indonesia to sell your products, also named as PT PMA, you need to have a local partner to distribute your goods.
If you are a local company that wishes to apply to register your food products, you can also assist us to learn about the details of the application process and documentation.
In summary, the general documents you need to submit are:
- Data on imports
- Approval for registration for consumer foods
- Letter of Declaration as Sealed and Signed (Product is not meant for retail sale) (Exempted for food items bearing an identification number)
- Analysis Certification (QC Report)
- Health Qualification/ Sale Certificate in the country of origin from the appropriate authority (for raw ingredients and additives).
- Specification of goods, including:
Product definition / formulation / ingredients
- List of Packings, Billing
What We Can Offer to You for Registering at BPOM?
- As Mandreel, we can support you with the paperwork online and offline needed for importing goods to Indonesia according to the checklist of BPOM.
- We deliver consulting services for diverse ranges of firms, from micro-sized to large firms, and we have expert personnel devoted to each category to maintain their market growth and comply with regulations.
- In Singapore, Malaysia, Indonesia, we had hundreds of customers, so we are well-informed about the Indonesian market and the candidate importers' countries.
- We also collaborated effectively with many businesses, including the chemical sector, pharma, the food industry, and the FMCG industry.
- And most notably, in each and every step of the BPOM registration process needed for importing to Indonesia, we are here to assist you.
You can send us an email for any questions about our services and we will get back to you as soon as possible or in one working day. For a quick reply, please give us a call or send us a Whatsapp message. Thank you.