“BPOM has the function to supervise drug and food in Indonesia. In order to do so, BPOM was granted the right to license drug and food products, whether they are manufactured/distributed locally or imported/exported.”
The National Agency of Drug and Food Control of Indonesia, also known as Badan Pengawas Obat dan Makanan (BPOM) is a government agency responsible for controlling and supervising of drugs and food in Indonesia. It is a non-ministry institution that reports to the President through the Minister of Health. Under Presidential Regulation No. 80 of 2017 on the National Agency of Drug and Food, BPOM has the function to supervise drugs and food in Indonesia, both before the distribution of the products and when the products have been distributed. In order to do so, BPOM was granted the right to license drug and food products, whether they are manufactured/distributed locally or imported/exported.
Products that require BPOM Permits
Generally speaking, BPOM has the right to oversee drugs and food products. To be specific, this includes:
1. Drugs
Drugs refer to biological products used to affect or investigate physiology system or pathology condition to diagnose, prevent, heal, recover, improve health, or contraception for humans.
2. Traditional drugs
Traditional drugs refer to ingredients or concoctions made from plants, animals, minerals, galenic, or a combination of them used for generations for medical purposes and are applicable according to the current norms.
3. Health supplements
Health supplements refer to products which purpose are to supplement nutrition needs, keeping, improving and/or repair the health function, which has nutritional value and/or physiology effect, which contain one or more ingredients of vitamin, mineral, amino acid and/ or other non-plant-based ingredients which are combinable with plant materials.
4. Cosmetics
Cosmetics refer to ingredients or preparations meant to be used on the out part of the human body (epidermis, hairs, nails, lips, outer part of genitalia) or teeth and mouth mucosa membrane for the purpose of cleaning, perfuming, changing the appearance, and/or deodorizing or protecting or keeping the body at fit condition.
5. Foods
Foods refer to everything made from biological sources of agricultural product, plantation product, forestry product, fishery product, farm product, and aquatic product, whether it has been processed or not, which purpose is for food or drink to be consumed by humans including any additional food materials used to prepare or process the food/drink.
When would you need BPOM Permits?
The previously explained products would need permits from BPOM which permit each product needs and when they need it depends on the situation. In general, there are three types of permits issued by BPOM, which are:
- Distribution permit
The distribution permit. also known as Izin Edar is a permit for drugs and foods manufactured locally or imported, which will be distributed in the region of Republic of Indonesia according to the evaluation of safety, quality, and benefit. In other words, this permit is attached to the product and is required if it wants to be distributed in Indonesia. According to BPOM Regulation No. 26 of 2018 on Electronically integrated Licensing Service on Drugs and Food Sector (“BPOM Regulation No.26/2018), drugs, traditional drugs, health supplements, cosmetic, and processed food products would require this permit. However, since it’s a distribution permit, it would be required when the product is ready to distributed in the market. In other words, when the product is still being manufactured or imported from overseas, it won’t require this permit.
2. Certificate of good manufacturing/distributing
Certificate of good manufacturing/distributing is proof that the manufacturer/distributor of the product is following the manufacture/distribution method, which is up to BPOM’s standard. Certificate of good manufacturing is required for the following products: drugs, traditional drugs, cosmetics, and processed foods. This certificate is also a requirement to acquire a distribution permit. In addition, certificate of good distributing is required for drug products is a requirement in order to acquire pharmacy wholesale permit from the Ministry of Health.
3. Export/Import documents
While export and import, in general, falls under the right of the Ministry of Trade, BPOM also has the right to attach additional export/import requirements based on BPOM Regulation No.26/2018. For example, for drugs, traditional drugs, health supplements, cosmetics, and food, they would require export permit from BPOM to be exported overseas. Additionally, drugs and food also require an import permit. As BPOM has no jurisdiction outside of Indonesia, these permits are required in order to make sure the products leaving from Indonesia and coming to Indonesia are still up to BPOM’s standard.
Sanctions
One of BPOM’s functions is to impose sanctions for violations against drugs and food regulations. In general, these sanctions include administrative sanctions such as revocation of the permits, suspension of the permit application process, and/or prohibition of business for a certain period. However, it should be noted that on top of administrative sanctions from BPOM, according to Law No. 36 of 2009 on Health and its amendments, there are also criminal sanctions for those who manufacture or distribute drugs and food without the required permit. Such violation is charged with up to 15 years of imprisonment and fines up to IDR 1,5 billion.
Author: Benedictus Giovanni