BPOM Health Supplement Registration

Health supplements (Suplemen Kesehatan) refer to products that supplement nutritional needs, maintain, enhance, or improve health functions, and contain one or more ingredients in the form of vitamins, minerals, or amino acids. This includes multivitamin products intended to maintain a healthy body.

Basic Informations

1. Health supplements (Suplemen Kesehatan) refer to products that supplement nutritional needs, maintain, enhance, or improve health functions, and contain one or more ingredients in the form of vitamins, minerals, or amino acids. This includes multivitamin products intended to maintain a healthy body.

2. The main requirements for applying for BPOM (National Agency of Drug and Food Control) health supplements are as follows:

a. Having an existing company in Indonesia (including the corresponding business classification code—KBLI).

Type	Business Scopes (KBLI)	Notes
Manufacturer	21012 – Human pharmaceutical industry	Health supplements
Manufacturer	21022 – Traditional human medicine industry	Traditional medicine, health supplements
Importer	46441 – Trade in human pharmaceuticals	Traditional medicine, health supplements
Importer	46442 – Trade in traditional human medicine	Traditional medicine, health supplements

b. Having a BPOM-approved warehouse in Indonesia (the address must be included in the company’s NIB)
c. Having a full-time PJT (Person in Charge of Technical Affairs) in Indonesia, who holds at least a bachelor’s degree in pharmacy.

3. Health supplements circulating in Indonesia can be classified into the following categories:

Type	Product category	Distribution Number (NIE) Code
Imported	Imported supplements	SI
Local	Health supplements	SD

4. The BPOM distribution number for health supplements is valid for 5 years. It can be extended as long as there are no changes to the product data. If there are any changes, a modification/update must be made first.

5.      Labeling information required on the packaging of health supplements includes:
a.      Product name
b.      Description note indicating “Health Supplement”: “Suplemen Kesehatan”
c.      Product form
d.      Name and address of the manufacturer
e.      Name and address of the contract giver/contract acceptor (if any)
f.       Name and address of the licensor/licensee (if any)
g.      Size, content volume, and net weight
h.      Qualitative and quantitative composition of ingredients
i.       Quantitative composition of additives
j.       Product efficacy claims
k.      Directions for use/method of use
l.       Contraindications, side effects, and precautionary warnings (if any)
m.     BPOM product distribution number
n.      Batch number/code
o.      Expiration date
p.      Storage conditions
q.      QR code
r.       Special information (if any)
s.      Information on sweeteners, coloring agents, preservatives, and flavorings

Processing Time & Required Documents

Processing Time : 8 Months

Required Documents :

1.      Administrative documents
a.      BPOM account information (username and password)
b.      Company documents (Business Registration Certificate NIB, Tax ID NPWP, Articles of Association, Ministry of Justice approval, information about directors)
c.      Manufacturer’s GMP certificate
d.      BPOM warehouse inspection report
e.      Letter of Authorization / Letter of Appointment (valid for at least 3 years at the time of product registration)

2.      Pre-application required documents
a.      Main ingredients (per batch)
b.      Letter of authorization for the person responsible for product registration
c.      Statement letter declaring the authenticity of documents
d.      Certificate of Free Sale or Certificate of Pharmaceutical Product issued by the competent authority in the country of origin and notarized/authenticated by the Indonesian Embassy in China
e.      Appointment letter from the manufacturer in the country of origin
f.       Product manufacturing method (production flowchart)
g.      Certificate of Analysis for raw materials
h.      Certificate of Analysis for finished products
i.       Specifications and testing methods for finished products
j.       Product packaging specifications
k.      Product batch number/code
l.       Safety test report from a laboratory recognized in Indonesia
m.     Capsule shell analysis certificate, BSE-TSE free certificate, and halal certificate issued by an authorized institution
n.      Chloramphenicol test (if required)
o.      Stability test report
p.      Packaging design (requires sworn translation)
q.      Safety or efficacy proof report
r.       Toxicity test results report
s.      Source and procurement process of raw materials (if applicable)
t.       Halal certificate for raw materials from non-marine animals (if applicable)
u.      Photos of the product and original packaging