Egyptian Drug Authority

 
Services > Registration > Veterinary

The Veterinary Registration Department
The veterinary registration department is a branch of the registration division at CAPA. 

The main goal of the department is the regulation of veterinary medicines which is an important part of wider efforts in society to promote the health and wellbeing of animal populations. Veterinary medicines play a vital role, both in caring for animals and in protecting public health (for example when used to ensure that food products of animal origin are safe or to prevent the spread of animal-borne diseases). It is therefore important to ensure the availability of high-quality, safe and effective medicines for veterinary use. 

In simple terms, the regulation of medicines involves deciding whether or not new medicines developed by the pharmaceutical industry is suitable to be placed on the market, and whether they continue to be safe for use once they are on the market.

* Any medicine should be registered at the Ministry of Health and given MOH Registration Number before it can be traded. 

  New contacts for veterinary Department


Guidelines for Submission of Soft File: 

    Applicant sends an appointment request to vet2@eda.mohealth.gov.eg
    CAPA will send back an email to inform the applicant with the date and time for application submission.
    CAPA will receive a maximum 10 applications per day, 3 days per week (no submission meetings on Thursday & Monday).
    If the company representative was late 15 minute after the pre-determined appointment, the meeting will be cancelled and the company has
       to ask for another appointment.
    Accepting the application doesn't guarantee a market authorization, only when the company receives the final authorization.
    Application file might be rejected at any stage and the reason of rejection will be given to the applicant. 

Useful Links:

    Request Inqury Requirements
    Steps for request inquiry submission
    SOPs for Naming
    New registration flow diagram
    Veterinary Drug New Registration Workflow
    Veterinary Drug Re-Registration Workflow
    Veterinary Registered Products in 2009-2014
    Technical & Scientific Committee decisions concerning Veterinary Products
    List of reference countries
    List of references for submission of new request inquiry form
    Scientific Insert


Different Requirements for veterinary medicine registration & re-registration steps:
 
    Documents required for soft file submission of new product (Arabic version)
    Documents required for soft file submission of re-reg product (Arabic version)
    Documents required for soft file submission of new product (English version)
    Documents required for soft file submission of re-reg product (English version)
    Documents required for hard file submission of new product
    Documents required for hard file submission of re-reg product
    Requirements for changing manufacturing site
    Requirements for changing license holder of veterinary product
 
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