Certificate for Good Distribution Practice of Pharmaceuticals

UMKU Details

Parameter: All

Authority: Minister/Head of Agency

  1. Requirements:
    1. Evidence of PNBP payment Duration: -
    2. Certificate of Pharmaceutical Distribution/Branch Pharmaceutical Distribution Duration: -
    3. Good Distribution Practice (CDOB) Standards Duration: -
    4. Standards and Requirements for Good Distribution Practice (CDOB) Certification Duration: -
  2. Responsibilities:
    1. Submit an application for changes to the CDOB Certificate when making changes to distribution facilities and/or CDOB Certificate-related information Duration: -
    2. Conduct drug and medicinal material management in accordance with the Good Distribution Practice (CDOB) Standards Duration: -
    3. Submit an application for changes to the CDOB Certificate when making changes to distribution facilities and/or CDOB Certificate-related information Duration: -
    4. Submit periodic reports as required by regulations Duration: -
    5. Submit an application no later than 12 (twelve) months and no earlier than 6 (six) months before the expiration of the CDOB certificate's validity period Duration: -
Sector: Medicine and Food
Status: Available

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