1.      Traditional medicine (Obat Tradisional) refers to substances containing plant, animal, or mineral materials that have been used for generations in treatment, including herbal preparations for relieving physical pain.

2.      The main requirements for applying for BPOM traditional medicine registration are as follows:

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

–        The company must have a BPOM-approved warehouse in Indonesia (the warehouse address must be included in the company’s NIB).

–        Have a full-time PJT technical supervisor in Indonesia with at least a Bachelor’s degree in Pharmacy.

3.      Traditional medicines circulating in Indonesia can be classified into the following categories:

4.      The BPOM distribution number for traditional medicines is valid for 5 years and can be extended as long as the product data remains unchanged. If there are any changes in the data, an amendment or modification must be made first.

5.      The label information required on the packaging of traditional medicines includes:
a.      Product name
b.      Form/shape
c.      Packaging size (dimensions, content volume, net weight)
d.      Quantitative and qualitative composition
e.      Mark indicating whether it is herbal, science-based herbal, or clinically-based herbal medicine
f.       Manufacturer’s name and address
g.      Importer’s name and address
h.      Licensor/licensee’s name and address (if applicable)
i.       Contract grantor/recipient’s name and address (if applicable)
j.       BPOM product distribution number
k.      Product batch number
l.       Expiry date
m.     Efficacy claims
n.      Usage instructions/methods
o.      Side effects, precautionary warnings, contraindications, pharmacological effects (if any)
p.      Storage conditions
q.      QR code or 2D barcode
r.       Special information (if any)
s.      Information on sweeteners, colorants, preservatives, and flavorings