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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2025-04-25
  • RTF Template


    Federal Agency For Medicines And Health Products

    UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

    Human medicinal products


    1. Authorisation Number

    :

    989 H

    2. Name of Authorisation Holder

    :

    EG

    (ORG-100002082 / LOC-100000522)

    3. Address(es) of Site(s)

    :

    Bus B22, Heizelesplanade S/n, Brussels, 1020, Belgium 




    4. Legally registered address of Authorisation Holder

    :

    Bus B22, Heizelesplanade S/n, Brussels, 1020

    5. Scope of authorisation

    :

    ANNEX 1

    6. Legal basis of authorisation

    :

    Art. 77(1) of Directive 2001/83/EC

    7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation

    :

    Confidential, Confidential

    8. Signature

    :


    9. Date

    :

    2023-09-26

    10. Annexes attached

    :

    Annex 1 Scope of wholesale distribution authorisation

    Annex 2 (Optional) Address(es) of contract wholesale distribution sites and their authorisation number

    Annex 3 (Optional) Name(s) of responsible person(s)

    Annex 4 (Optional) Date of Inspection on which authorisation was granted

    Annex 5 (Optional) Additional provisions based on national requirements


    ANNEX 1

    SCOPE OF WHOLESALE DISTRIBUTION AUTHORISATION



    Name and address of the site: EG

    (ORG-100002082 / LOC-100000522)

    , Bus B22, Heizelesplanade S/n, Brussels, 1020, Belgium   



    Human medicinal products


    1. MEDICINAL PRODUCTS

       1.1. with a Marketing Authorisation in EEA country(s)


    2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

       2.1. Procurement 

       2.2. Holding 

       2.3. Supply 


    3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

         3.1.1. Narcotic or psychotropic products 

       3.3. Cold chain products(requiring low temperature handling) 




    Any restrictions or clarifying remarks (for all users):  2.2.: Limited to the holding of medicinal samples and retention samples.
    3.3.: Authorized temperature for the cold chain : 2-8°C

    2.2.: Beperkt tot het houden van medische monsters en retentiestalen.
    3.3.: Toegestane temperatuur voor de koude bewaring : 2-8°C








    Reason for Withdrawing:

    made new WDA due to technical problems with update of the WDA








    Union Format for a Wholesale Distribution Authorisation

    989 H


    Page 1





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