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    8.0 Registration Processes
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    8.0 Registration Processes

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    Infant, Follow-up, Young Child Formula
    Indonesia


    This section provides information on any product notification or registration and manufacturing site registration processes.

    8.1 Product Notification

    N/A

    8.2 Product Registration

    Infant, Follow-up, and Young Child Formula 

    Products must be registered with BPOM/NADFC [1]. The required documents are: [2]

    1. Certificate of analysis 
    2. Ingredient list
    3. Manufacturing process
    4. Production code information
    5. Expired date information
    6. Raw materials specification 
    7. Label design
    8. Health certificate/ Free sale certificate (for imported)
    9. Letter of authorization (for imported)
    10. Good Manufacturing Practice Certificate/HACCP/ISO 22000 
    11. Product photo

    The registration fee is Rp.3.000.000 while the estimated timeline is 30 working days. Please note that the actual registration process could take longer. It is conducted via https://e-reg.pom.go.id/. The user needs to be registered (can be a local importer or distributor).

    8.3 Other Notes or Requirements

    None

    8.4 Manufacturing Site Registration

    Infant, Follow-up, and Young Child Formula [1]

    On product registration documents, it is required to state the name and address of the manufacturing site. GMP/HACCP/ISO 22000 certificate will be required for product registration. There is no manufacturing site registration procedure.

    8.4.1 Standard/Rules for Manufacturing Site

    Infant Formula [3]

    BPOM Decree No. HK.03.1.23.12.11.10720 Year 2011 for powder describes Good Manufacturing Practices. It refers to the Codex Code of Hygienic Practice for Powdered Formulae for Infants and Young Children. It was developed as there was a concern about powdered infant formula with Enterobacteriaceae sakazakii in 2011 in Indonesia.

    Both local and import manufacturing site need to apply for Good Food Safety Practice, this can be proved by certificate of GMP/HACCP/ISO 22000.

    8.4.2 Other Notes or Requirements for Manufacturing Site Registration

    None

    8.5 References

    1. FAQ Food Registration
    http://registrasipangan.pom.go.id/index.php/page/umum 


    2. BPOM Guidelines Foods Registration (E-Book 3)
    http://registrasipangan.pom.go.id/index.php/page/download 


    3. Regulation Of The Head Of The Drug And Food Control Agency Of The Republic Of Indonesia Number Hk.03.1.23.12.11.10720 Year 2011 Concerning Guidelines For Production Of Good Processed Food For Infant Formula And Advanced Formula For Powder

    https://standarpangan.pom.go.id/dokumen/peraturan/202x/PERATURAN_KEPALA_BADAN_PENGAWAS_OBAT_DAN_MAKANAN_REPUBLIK_INDONESIA_NOMOR_HK.03.1.23.12.11.10720_TAHUN_2011_TENTANG_PEDOMAN_CARA_PRODUKSI_PANGAN_OLAHAN_YANG_BAIK_UNTUK_FORMULA_BAYI_DAN_FORMULA_LANJUTAN_BENTUK_BUBUK.pdf 

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