01.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.
02. 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).
