Approval Letter for Changes to Quasi-Drug Marketing Authorization

  1. Micro, Small, and Medium Enterprises (UMKU) Details
    Parameter: All
    Authority: Minister/Head of the Agency
    Requirements:
    1. Proof of payment of Non-Tax State Revenue (PNBP)
      2. Duration: -
    2. Standards, Criteria, and Procedures for the Registration of Quasi-Medicines
      3. Duration: -
    3. Standards for Safety and Quality Requirements of Quasi-Medicines
      4. Duration: -
    4. Compendial standards that can be used as references: Indonesian Pharmacopoeia/Herbal Indonesian Pharmacopoeia, International Compendial/Standards, and/or other reference analysis methods
      5. Duration: -
  2. Obligations:
    1. Ensure the safety, efficacy, quality, and labeling of Quasi-Medicines
      2. Duration: -
    2. Complete the registration documents
      3. Duration: -
Sector: Drugs and Food
Status: Available
Belongs to:
21012
21022
46441
46443
47723
47999

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