registration

Our Registration Department Deals with the Supreme Board of Drugs and Medical Appliances - MOH ensuring that all the regulatory requirements are complied with. This enables the Division to quickly bring out Pharmaceutical products & Medical appliances into Yemen Healthcare market.

• 1. Registration Requirements for Manufacturer with SBDMA:

WHO GMP / cGMP / US FDA /EMIA (legalized by the Yemeni embassy). Site Master file. Agent’s distribution agreement legalized by the Yemeni embassy Products catalogue Note: GMP inspection will be required if the company is not registered in GCC. This will be required after getting the initial approval for company registration.

• 2. Product dossier should include the following documents:
• A. Administrative documents:
  
  • i. Free sales Certificate / COPP legalized by the Yemeni embassy
  • ii. Product’s GMP or Manufacturing License legalized by the Yemeni embassy. ​

• B. Pharmaceutical documents:
  • 1- Product’s Name.
  • 2- Manufacturer’s name
  • 3- Price- CIF Sana’a airport
  • 4- Composition
  • 5- Manufacturing process
  • 6- Analysis Certificate
  • 7- Insert Leaflet
  • 8- Finished/Standard/Reference sample (for registration & Analyses Required Qty:
    
    • a. Tablets and caps=100 tabs/caps 
    • b. Vial/amp=60vials/amp 
  • 9- Method of Analyses
  • 10- Stability Report 
  • 11- Stability study on Shelf for 3 batches
  • 12- Accelerated Stability study for 3 batches
  • Bioequivalence Study (for Orals only and as determined by MOH at the initial stage of product registration depending on the type of the product).