The Indonesian National Drug and Food Control Agency or locally known as BPOM released a regulation No 8 Year 2020 on Online Sale of medicines and food. This regulation governs the online sale of medicines, traditional medicines, health supplement, cosmetic, and processed food.
Under the regulation, only Pharmaceutical Industry, licensed offline pharmacies, and drug wholesalers (PBF) are allowed to sell medicines online, while the sale of traditional medicines, health supplements, cosmetics and processed food can be performed by anyone.
The Online Sale of Medicines in Indonesia
Who can sell medicines online?
Pharmaceutical Industry, licensed offline pharmacies, drug wholesalers (PBF), and branch drug wholesalers (PBF cabang) who sell the medicines online, have to use the electronic system and are obliged to ensure that requirements are met for safety, efficacy, and product quality according to applicable laws.
Pharmaceutical Industry and drug wholesalers (PBF) must have their own electronic system in order to sell the medicines online, while the branch drug wholesalers (PBF cabang) must use the main drug wholesalers (PBF) electronic system. This means that selling medicine through the market place is not allowed.
Licensed offline pharmacies who want to sell the medicines online must use either their own electronic system or a suitable service from a pharmacy electronic system provider (PSEF), or e-pharmacy providers.
Category of Medicines
Category of medicines which can be sold through e-pharmacy are Non-prescription medicine including OTC product (green dot label); Limited OTC (blue dot label) and Prescription drug (red dot label).
There are certain types of medicines which are prohibited to be sold by e-pharmacy providers:
- Certain prescription medicines which are prohibited according to laws (not clearly mentioned in the regulation)
- Medicines containing precursor
- Medicines to treat erectile dysfunction
- Injectable drug except insulin for self-use
- Implants
- Narcotics and Psychotropics
Other requirements for Pharmacy
For prescription drugs, it is obliged to have the prescription either directly from the electronic system (e-prescription) or from uploading the paper prescription into the system. And then Pharmacy must verify that the prescription is original before proceeding it.
Required Documentation
Pharmaceutical Industry, licensed offline pharmacies, drug wholesalers (PBF), and branch drug wholesalers (PBF cabang) who sell the medicines online must provide regular reports, containing information about URL, list of medicines and online transactions
The Online Sale of Traditional Medicines, Health Supplement and Cosmetics in Indonesia
Who can sell medicines online?
Different from medicines category, anyone can sell Traditional Medicines, Health Supplement, and Cosmetics online as long as they ensure requirements are met for the safety, efficacy, and quality of the product according to applicable laws.
In order to sell Traditional Medicines, Health Supplement and Cosmetics online, they must use either their own electronic system, or a suitable service from an electronic system provider (PSE).
Both the seller and the electronic system provider (PSE) must guarantee that the electronic system is able to:
- Accurately inform the identity of seller
- Ensure that all product information in accordance with applicable laws
- Record and trace all the product distribution related information
Category of Traditional Medicines, Health Supplement and Cosmetics
Any Traditional Medicines, Health Supplement and Cosmetics can be sold online, except:
- Cosmetics containing Alpha Hydroxy Acid (AHA) more than 10%
- Teeth whitening containing and/or releasing Hydrogen Peroxide (H2O2) more than 6%
Retention of Documentation
- All electronic transaction information related to product distribution have to be retained at least 5 years.
Due and Sanctions
- Licensed offline pharmacy, pharmacy electronic system provider (PSEF), electronic system provider (PSE) and business player must implement this regulation at least 3 months after this regulation was promulgated (July 2020). Administrative sanctions applied for those who violate.
Reference
- Peraturan Badan Pengawas Obat dan Makanan Nomor 8 Tahun 2020 Tentang Pengawasan Obat dan Makanan yang Diedarkan secara Daring, Badan Pengawas Obat dan Makanan Republik Indonesia
