Indonesia Pharmaceutical Registration and Approval
In the Association of Southeast Asian countries (ASEAN), Indonesia has the biggest pharmaceutical market. The Indonesian National Agency of Drug and Food Control (BPOM) regulates the drug registration process in Indonesia. To import drugs into Indonesia, the importer must first obtain a Letter of Import (called SKI) from BPOM. Local companies, agents or distributors must complete the registration process before the products are allowed to be cleared through Indonesian customs.
For drug registration in Indonesia, drugs are classified into 4 categories including OTC products with warning labels (Category W), Narcotics (Category O), over the counter (OTC) products (Category F), and prescription drugs (Category G).
The process of obtaining the SKI FOR DRUG REGISTRATION IN INDONESIA is outlined below.
1. Register online by visiting http://www.ebpom.pom.go.id or http://eservice.insw.go.id.
2. Upload THE required original documents to one of the two websites above. Required documents include a letter of application, a Business Identification Number which can act as the Importer Identification Number, a letter of responsibility, a Trading Business License, a Tax ID, a power OF attorney letter for importing, Harmonized System (HS) codes of the imported products, and for SKI of drugs, a Pharmaceutical Industry License.
3. Complete the electronic payment
4. Submit the electronic documents such as certificate of analysis, declaration letter from the manufacturer in the country of origin, distribution approval license, proof of payment, etc.
5. When applying for vaccine and serum importation, it is necessary to provide the following documents: a batch/lot release certificate issued by the relevant authority in the country of origin, a summary of the batch/lot protocol, and a certificate of analysis with information on the source of the active substance.
Individuals or organizations that can apply for a Drug Import Application in Indonesia are domestic manufacturers who have been authorized by foreign manufacturers. To be eligible, the domestic manufacturer must have a valid Good Manufacturing Practice (GMP) license. The GMP license of the domestic manufacturer must have been inspected within the last two years to be considered valid. In case the domestic manufacturer does not have authorization to market the same dosage form in Indonesia, or if there has been a change in the production facility for the same dosage form, they need to provide a Site Master File (SMF). If the SMF requires proof of GMP compliance, a Site Inspection may be carried out.
To learn more about how PBM can help you register your drug products in Indonesia, please contact us.