Medicinal Product Support in Indonesia

Medicinal Products Regulatory Support in Indonesia – Overview

The Indonesian pharmaceutical market, the largest in Southeast Asia, is growing rapidly due to its large population, rising middle class, and expanding economy. Government initiatives like the national health insurance program are driving higher demand for healthcare services. BPOM oversees approvals, requiring local MAH representation, eCTD dossiers, GMP compliance, and price clearance. Freyr Solutions guides companies through the regulatory journey from strategy and dossier preparation to submissions and authority interactions ensuring efficient, compliant market access.

Medicinal Product Classification in Indonesia

BPOM classifies medicinal products into four main categories:

1. Traditional Medicines (Obat Tradisional)

• Composition: Crafted from natural ingredients such as herbs, roots, and spices (e.g., jamu).
• Usage: Primarily for general wellness, digestion, and immunity.
• Regulation: Must be registered with BPOM. While they do not replace medical treatment for serious conditions, they are legally recognized and regulated.

2. Over-the-Counter (OTC) Medicines

• Categories:
  • Obat Bebas (Green Label): e.g., paracetamol, vitamins.
  • Obat Bebas Terbatas (Blue Label): e.g., cough syrup, antihistamines.
• Access: Available without a prescription.
• Regulation: Must be registered with BPOM. While they can be purchased without a prescription, misuse should be avoided.

3. Prescription Medicines (Obat Keras)

• Identification: Marked with a red "K" symbol.
• Access: Requires a doctor's prescription (e.g., antibiotics, insulin, blood pressure medication).
• Regulation: Strictly regulated; misuse can lead to serious health risks, such as antibiotic resistance.

4. Medically Controlled Substances (Narcotics & Psychotropics)

• Identification: Marked with a red "N" symbol.
• Access: Strictly regulated due to addiction risks (e.g., morphine, codeine).
• Regulation: Only available in hospitals or licensed pharmacies with a special prescription. Illegal to possess without authorization.

Medicinal Product Drug Registration & Approval

BPOM governs the registration, pricing, and marketing authorization of all medicinal and pharmaceutical products in Indonesia. Its objective is to ensure that only safe, effective, and high-quality medicines reach the market, whether locally manufactured or imported.

Key Steps in the Process:

1. Classification / Pre-assessment
   Before submitting a full registration, companies often need a product classification letter from BPOM. This determines the regulatory pathway.
2. MAH & Local Agent / Warehouse Licensing
   The Marketing Authorization Holder (MAH), whether local or foreign via an Indonesian agent, must be registered/licensed with BPOM. Also, the importing/distribution must be via BPOM-licensed medical warehouse.
3. Submission of Dossier
   The applicant submits a dossier (in many cases in eCTD format) which includes modules covering quality, safety, and efficacy. Required documents typically include: GMP certificate of manufacturer, certificate of free sale or Certificate of Pharmaceutical Product (CPP), full formulation detail, manufacturing site details, labelling and leaflet artwork, and often Halal certificate for relevant products.
4. Technical Review & Committee Deliberation
   BPOM assigns a technical committee to review the dossier. If acceptable, the dossier is forwarded to a ministerial/higher committee for final approval. Additional lab analysis, sample testing, or clarifications may be requested.
5. Issuance of Registration Certificate
   Once approved, BPOM issues a registration certificate. For general sale products (limited medicinal use), the certificate is valid for five years. Locally manufactured product certificates often have a one-year validity for certain certificates like pharmaceutical site licensing.
6. Renewal & Amendments
   Registrations must be renewed (every 5 years for general sale/product registration). Any minor or major changes (formulation, manufacturing site, labelling, etc.) need submission of amendments or variations for approval.
7. Post-Approval / Obligations
   After registration, BPOM requires compliance with quality (GMP), batch release, labelling standards, pharmacovigilance (safety reporting), possibly periodic re-inspection, and ensuring that any changes are pre-approved.