Supervision of Food and Drugs Distributed Online
The National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan or “BPOM”) issued its Regulation No. 8 of 2020 dated April 7, 2020 on the Supervision of Drugs and Food Distributed Online (“BPOM Reg. 8/2020”) as an implementing regulation as referred to in Article 35 paragraph (3) of Government Regulation No. 71 of 2019 dated October 10, 2019 on the Organization of Electronic Systems and Transactions.
As mandated under Presidential Regulation No. 80 of 2017 dated August 9, 2017, on the National Agency of Drug and Food Control (BPOM), BPOM is authorized to supervise food and drugs in Indonesia. Through tthe BPOM Reg. 8/2020, BPOM intends to protect consumers from the risk of unsafe food and drugs that may be available in the online market.
Previously, on October 17, 2019, BPOM signed a Memorandum of Understanding (MoU) with the Indonesian E-Commerce Association (idEA) and several online marketplace platforms (Bukalapak, Tokopedia, Gojek, Grab, Klikdokter, and Halodoc) to cooperate in the supervision, delivery, and marketing of food and drugs. BPOM Reg. 8/2020 is the first regulation to provide comprehensive provisions on the supervision of food and drugs that are accessible online.
Pertinent provisions in the BPOM Reg. 8/2020 are as set forth below.
- Online Distribution of Food and Drugs
BPOM requires that all drugs, traditional medicines, health supplements, cosmetics, processed foods (except (i) ready-to-serve foodstuffs; and (ii) foodstuffs that are to be used as raw materials by business actors which are not sold directly to end consumers) and processed food for special medical purposes (pangan olahan untuk keperluan medis khusus or PKMK) that are distributed online to obtain distribution licenses and to meet the proper manufacturing methods. A more elaborate information regarding the online distribution of these products is stated in the following table.
|Allowed Products||Sellers||Buyers||Means of Distribution||Obligations|
|1. Drugs, including:
a. Over-the-counter (“OTC”) drugs (obat bebas);
b. Limited OTC drugs (obat bebas terbatas); and
c. Prescription drugs (obat keras).
|Pharmacies or pharmacies in collaboration with other legal entities.||Patients||Electronic systems owned by pharmacies and/or provided by the Pharmacy’s Electronic System Provider (“PSEF”).
It is to be noted that the data retention requirement of all drug transactions online is at least 5 (five) years.
|Business actors carrying out drug distribution activities online must:
1. Guarantee that the electronic systems utilized meet certain criteria, i.e., provision of electronic data backup system, accessible by BPOM at any time, and information that users must submit original prescriptions prior to drug purchase;
2. Conduct supervision and evaluation of all drug distribution; and
3. Submit regular reports which include several information, i.e., list of drugs distributed online, names of PSEF, and transaction data.
|2. PKMK||Pharmacies||Business actors carrying out PKMK distribution activities online must:
1. Guarantee that the electronic systems utilized meet certain criteria, i.e., provision of electronic data backup system, accessible by BPOM at any time, and information that users must submit original prescriptions prior to drug purchase; and
2. Conduct supervision and evaluation of all drug distribution.
|3. Traditional medicines, health supplements and/or cosmetics||Business actors or business actors in collaboration with other legal entities.||Consumers||Electronic systems owned and operated by sellers and/or provided by any Electronic System Provider (an “ESP”).
|Business actors carrying out the online distribution of traditional medicines, health supplements and/or cosmetics must:
1. Guarantee that the electronic systems utilized meet certain criteria, i.e., accessibility of certain information and provision of mechanism for the recordation of distribution;
2. Guarantee that the condition of the traditional medicines, health supplements and/or cosmetics up to the delivery;
3. Deliver the traditional medicines, health supplements and/or cosmetics in a closed container;
4. Guarantee that the traditional medicines, health supplements and/or cosmetics is delivered to the designated address;and
5. Document the handover of the products.
|4. Processed Food||Business actors carrying out processed food distribution activities online must:
1. Provide certain information, i.e., name and address of the seller and other relevant data;
2. Guarantee that the condition of the processed food up to the delivery;
3. Deliver the processed food in a closed container; and
4. Maintain the condition of the delivery in accordance with the characteristics of the product.
- BPOM Supervision and Guidance
BPOM supervises the online distribution of food and drugs by carrying out inspection of the products as well as the online advertisements and examination of related means or means that are suspected to be conducting distribution activities of food and drugs online.
BPOM also provides guidance to business actors that distribute food and drugs online through communication, information, and education, and/or assistance in order to fulfill the standards and requirements of the relevant products distributed. In addition, BPOM provides guidance to consumers through communication, information, and education, and/or the formation of food safety facilitator.
- Prohibited Products
BPOM prohibits several food, drugs, and cosmetics from being distributed online, as set forth in the table below.
|1. Drugs||a. Certain prescription drugs (obat keras tertentu or OKT);
b. Drugs that contain pharmaceutical precursor;
c. Drugs for erectile dysfunction;
d. Injections other than insulin for personal use;
e. Implants which use requires the assistance of health workers; and
f. Narcotic drugs and psychotropic substances.
|2. Cosmetics||a. Skin care products that contain alpha-hydroxy acids (AHA) greater than 10% (ten percent); and
b. Teeth whitening products that contain hydrogen peroxide greater than 6% (six percent).
Further, BPOM prohibits the promotion and marketing of drugs and the distribution of drugs and PKMK through social media, daily deals, and classified ads.
- Imposition of Sanction
Business actors that violate BPOM Reg. 8/2020 may be subject to administrative sanctions in the form of warnings, recommendations to close or restrict the relevant electronic systems, recommendations to revoke pharmaceutical service facility licenses, temporary prohibition of distribution, and/or order to recall relevant food and drugs.
June 5, 2020
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- June 5, 2020