RegulinkedOMAN MOH issued new Circular No. 35/2026 introducing updated restrictions on the use of Ivy Leaf Extract in herbal medicines intended for pediatric populations.
🔍 What’s new:
The update includes age-related use limitations and a defined compliance timeline for manufacturers, importers, and local agents.
Key points include:
- Ivy Leaf Extract shall not be used in products intended for children under two (2) years of age.
- Use of Ivy Leaf Extract in products intended for children aged two (2) to less than four (4) years shall be limited to the approved dosage stated in the product leaflet.
- All companies, manufacturers, and local agents are required to comply with these requirements.
- Compliance must be achieved within a period not exceeding three (3) months from the date of issuance of the circular.
💡 Required Industry Action / Relevance:
Manufacturers, importers, and local agents should review affected herbal medicine portfolios, product labeling, dosage instructions, and pediatric indications to ensure alignment with the updated requirements.
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🔗 Official Circular (PDF): Circular No. 35-2026 – Use of Ivy Leaf Extract
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