Egyptian Drug Authority

Services > Registration > Cosmetics

Department of Registration of Cosmetic Products

The Department is responsible for registration of cosmetic products including (Local – Toll – Imported – under license) according to:

·  All The Ministerial Decrees governing the registration of cosmetics in Egypt.

·  The Regulations set by the Technical Committee for pharmaceutical products.

·  The Regulations of European Directive 76/768 EEC

·  The Regulations of The FDA

·  The Regulations of COLIPA

·  Publication list ( CIR )

Registration process of cosmetics starts by sending soft file for the product via e-mail by the company requiring registration, comments will be sent via email by the registration team, a complete hard copy is required to be submitted at our front office in CAPA.

    Notes :

1.  The applicant company should send the company profile before submitting a new registration file.

2. The company will send the soft file request to the following: 
     * Imported from reference countries: 
     * Imported from non-reference countries: 
     * Toll: 
     * Local:  

Application form

     N.B. Maximum number of files to be submitted by each company per week will be as follows:
    ·  3 files for toll, and under license products.

    ·  5 files for local products.

    ·  10 files for imported products.

3.  submission of files will take place 5 days weekly ( each section according to its schedule)

    SOP for pre-submission
    Old Registration System
    Documents required for registration
         - Imported From Reference Countries-Finished
         - Imported
         - Local
         - Toll
         - Under license:
            - Toll/Under License from reference Countries
            - Local/Under License from reference Countries
         - Re-registration
    New Registration System 
    Registration Of New Cosmetic Products Containing The Same Pre-Registered Formula 
    New Rules of Variation
    Transfer of manufacturing
    Transfer of ownership
    Company Profile for Factories
    Company Profile for Toll Pharmaceutical Manufacturer
    Company Profile for Agents
    How To Send A Soft Copy For A New Imported Cosmetic Product From Reference Countries
    Registration Committee Decisions (2018)
    Registration Committee Decisions (2017)
    Registration Committee Decisions (2016)