RegulinkedThe Ministry of Health (MOH) – Kuwait has issued Ministerial Decree No. (387) of 2025, establishing the regulatory requirements for the registration and circulation of herbal medicines, traditional herbal medicines, herbal natural supplements, and herbal teas in Kuwait.
The decree is issued by the Medicine and Medical Products Registration and Regulatory Administration and applies to all relevant products intended to be marketed or distributed in Kuwait.
🔍 What’s new:
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Establishes a dedicated regulatory framework for herbal medicines and herbal products, distinct from conventional pharmaceuticals.
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Defines product classification categories, including Herbal Medicines (HM), Traditional Herbal Medicines (THM), Herbal Natural Supplements (HNS), and Herbal Teas with medical claims.
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Introduces classification-based evidence requirements, distinguishing between products requiring clinical studies and those eligible for traditional-use evidence.
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Formalizes registration, renewal, variation, transfer of agency, suspension, and cancellation procedures.
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Publishes official annexes listing banned and restricted herbal ingredients, subject to ongoing updates.
💡 Why it matters:
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Provides regulatory clarity on how herbal products are assessed, classified, and approved in Kuwait.
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Clarifies compliance expectations related to claims, safety, quality, and efficacy evidence.
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Strengthens oversight of herbal products throughout their regulatory lifecycle.
📌 How ReguLinked can support you:
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Support interpretation and application of MD (389)/2025 requirements.
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Assist with product classification, registration, renewal, and variation submissions.
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Support review of claims, technical documentation, and compliance readiness.
📎 Official PDF: KUW -Registration of herbal medicines & herbal products
📨 Planning to Submit New, Renewal or Variation application in Kuwait?
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