Egyptian Drug Authority

Services > Registration > Variation

Variation Department

Variation department is classified under General directorate of registration-Human drug registration department, Established since October 2010. 

It's concerned with evaluating and assessing variations (minor or major changes) for pharmaceutical products, food supplements or veterinary products. 

  (19/03/2013), Variation committee decision for addition or replacement of sources for Raw Materials (API)

Guidance for variation
Provides supportive information on how to present an application to implement a change to a prequalified product.

  Pharmaceutical Products Variation Guidelines 2019 
  Last updated variation checklist 
  Regulations for the transition period of the supplier proposal 
  Guidelines for the addition or change of supplier 
  Links for online reservation for variation department 

The above Link will be available for receiving the pharmaceutical companies' suggestions concerning the supplier guidelines till 1/11/2013

Contact us:
Submission of request:
Wednesday from 12:00 pm – 2:30 pm (weekly) 


Tel. +202-2364288 +202-23640368 +202-23640368
Ext. 1204
Fax. +202-23684194
Monday from 11:00 am – 1:00 pm (weekly)