Table Of Contents (TOC) for EGYPT

EGYPT         

Authority

MOH, Drug policy and planning center

website

if any

DOSSIER REQUIRMENTS

S.No

Documents

Page No

1.

Certificate of Pharmaceutical Product (CPP), including composition per unit dose; issued by the Health Authorities and legalized by the Egyptian Consulate in the country of origin.

2.

GMP Certificate for the manufacturer; issued by the Health Authorities and legalized by the Egyptian Consulate in the country of origin.

3.

Letter of Authorization; legalized by the Egyptian Consulate in the country of origin.  

4.

Price Certificate; declaring public price in the country of origin and Fob Price to Egypt; legalized by the Egyptian Consulate in the country of origin.

5.

Composition per unit dose, declaring the specification reference for all ingredients (active/inactive).

6.

Analysis Certificate; each for the finished product and the active ingredient(s).

7.

Specification Reference for each ingredient as declared in the composition sheet (hard copy).     

8.

Patients Information Leaflet; Outer Label; Inner Label (maquette is accepted).    

9.

Stability Reports for at least three bathes; and Validation Method.

10.

Legalized FDA, WHO, or EMEA Certificates (if available).