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Food Supplement Registration in Cambodia

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Food Supplement Registration in Cambodia

Regulatory Authority

The Ministry of Health, Cambodia and Department of Drugs and Food (DDF) 

Timeline

Within 100 days

The Cambodia Pharmaceutical Online Registration System (CamPORS), sponsored by WHO, was inaugurated on August 1, 2019, by the Cambodian Ministry of Health. CamPORS is a digital transformation effort that aims to make registering Therapeutic Drugs, Cosmetics, Health Supplements, Health Supporting Products, Medical Devices, Traditional Medicine, and Brand & Label Clearance more efficient, transparent, and simple.

Document Required for Health Supplement Registration

                    I.        Administrative Document

    1. Application form (Annex I)
    2. Free Sale certificate (Letter Head of Drug Regulatory Authority: DRA)
    3. GMP or ISO Certificate
    4. Hygienic certificate
    5. Product Information (Annex II)

                   I I.        Technical Documents

  1. Unit Formula and Batch Formula
  2. Manufacturing Process –in process control
  3. Control Procedure of Raw Materials
  • Active ingredient(s) and Inactive ingredients.
  • Certificate of analysis of active ingredient(s) with its specifications
  1. Control Procedure of the finished product (Certificate of analysis of the finished product with its specifications.)
  2. Storage condition of the finished product and its predicted expiry date.
  3. Stability study

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