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Product classification is the first essential step in bringing any pharmaceutical product into the UAE. Conducted by the Ministry of Health and Prevention (MoHAP), this process determines a product’s regulatory pathway by evaluating its type, composition, and use.
All pharmaceutical, medical devices, healthcare-related and at times cosmeceutical products or products intended for human use must undergo classification by the MoHAP.
Classification provides clarity on:
Classification results are issued within 5-10 working days after submission, ensuring efficiency and clarity for manufacturers. These timelines are, however, subject to change, and so it is important to keep up with updated regulations and guidelines.
The Product Classification Certificate outlines key product details including the Name and Form of the Product, Committee M. Number, Manufacturer Country, and MoHAP assigned classification. The certificate is valid for 3 years.
It is important to note that any changes to the product, such as packaging or formulation, would require reclassification.
Product Classification precedes Product Registration, and both processes sit with the MoHAP.
How a product is classified by the MoHAP determines whether it goes on to be reviewed for approval by the MoHAP itself or whether it should go through the approval process overseen by other entities instead.
While classification determines the product’s regulatory standing, registration is a separate process reserved for the comprehensive review and assessment of conventional medicines/products before they can become officially listed and marketed in the UAE.
Understanding these distinctions ensures a smooth entry into the UAE healthcare market.
As the licensing partner of several international brands, HealthNet MEA submits and manages both Product Classification and Product Registration applications on behalf of pharmaceutical and medical device manufacturers who have no physical presence in the UAE.
For more information on this and collaborative opportunities, contact us at support@healthnetmea.ae