Ministry of Health
Central Administration for
Pharmaceutical Affairs
General Registration Department
Department of Biological Products
Registration
‫وزارة اﻟﺼﺤﺔ‬
‫اﻹدارة اﻟﻤﺮﻛﺰﯾﺔ ﻟﻠﺸﺌﻮن اﻟﺼﯿﺪﻟﯿﺔ‬
‫اﻹدارة اﻟﻌﺎﻣﺔ ﻟﻠﺘﺴﺠﯿﻞ‬
‫إدارة ﺗﺴﺠﯿﻞ اﻟﻤﺴﺘﺤﻀﺮات اﻟﺤﯿﻮﯾﺔ‬
Additional requirements for re-registration
checklist:
1- Declaration letter from the License holder signed and stamped stating the
following
- list of variations that the product has undergone since its last registration
- Date of variation implementation
- Status of variation in the Egyptian Authority (Approved / Submitted / Not
Submitted) with date of approval/submission
2- Approvals on the variations from the Health authority in the country of origin
3- Application for variation for each variation submitted describing before and
after variation
4- Last lot release report from NORCB
5- Recent Report from the inspection department at CAPA revealing that the
line of production of that product is valid (for local products) most recent
6- Last report of inspection of CAPA on the manufacturing facility (in case of
imported from non-reference country)
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Tel.: +202 – 23684288 +202 – 23648769 +202 – 23640368 Ext.:1305
Website: www.eda.mohp.gov.eg
Version: 1.1
Fax: +202 - 23684194
Email: biologicals@eda.mohp.gov.eg