Process
Clearance of pharmaceuticals and other medical supplies in the United Arab Emirates (UAE) involves regulatory compliance of imported items. The key requirements for the clearance of may vary but a general sketch is detailed below:
1. Import License:
- Importers need to obtain an import license from the relevant health authorities, demonstrating compliance with local regulations.
2. Registration with Ministry of Health (MOH):
- Items must be registered with the UAE Ministry of Health and Prevention (MOHAP). The registration process involves submitting detailed documentation, including product information, manufacturing details, and clinical data.
3. GMP Compliance:
- Good Manufacturing Practices (GMP) certification is sometimes crucial for approval.
4. Quality Control and Testing:
- Certificates of Testing is often required from accredited laboratories.
5. Labeling Requirements:
- Pharmaceutical packaging must comply with specific labeling requirements set by UAE authorities. This includes providing clear and accurate information on product composition, usage instructions, and safety precautions in both Arabic and English, production & expiration dates etc.
6. Cold Chain Compliance:
- For temperature-sensitive pharmaceuticals, adherence to cold chain requirements is crucial.
7. Documentation:
- Detailed documentation is necessary for customs clearance. This includes the Certificate of Analysis, Certificate of Origin, product registration certificates, import permit, and other relevant paperwork as required by the UAE MOH authorities.
8. Pharmacovigilance Requirements:
- Compliance with pharmacovigilance regulations is essential. Companies must have systems in place to monitor and report any adverse effects associated with their pharmaceutical products in the UAE market.
Please consult with us before importing your pharmaceuticals, Medical, hospital supplies.
