Approval Letter for Changes to Drug Marketing Authorization

  1. Micro, Small, and Medium Enterprises (UMKU) Details
    Parameter: All
    Authority: Minister/Head of the Agency
    Requirements:
    1. Standards and criteria for drug registration
      2. Duration: -
    2. Indonesian Pharmacopoeia standards and/or analysis methods, standards, and/or other requirements
      3. Duration: -
  2. Obligations:
    1. Ensure the safety, efficacy, quality, and labeling of drugs during the marketing authorization validity period
      2. Duration: -
    2. Implement Registration Variation Approvals
      3. Duration: -
    3. Report the quantity, batch numbers, and expiration dates of the last distributed batches to the Non-Ministerial Government Institution responsible for drug and food supervision
      4. Duration: -
Sector: Drugs and Food
Status: Available
Belongs to:
21012

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