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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2025-07-28
  • RTF Template


    Federal Agency for Medicines and Health Products

    UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION


    1. Authorisation Number

    :

    1896 H

    2. Name of Authorisation Holder

    :

    DSV Air & Sea NV

    3. Address(es) of Site(s)

    :

    Bedrijvenzone Machelen Cargo 829A, Machelen, 1830, Belgium 

    Straatsburgdok-Zuidkaai 6, Antwerpen, 2030, Belgium 




    4. Legally registered address of Authorisation Holder

    :

    Schoonmansveld 40, Puurs-Sint-Amands, 2870, Belgium

    5. Scope of authorisation

    :

    ANNEX 1

    6. Legal basis of authorisation

    :


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

    :

    Confidential, Confidential

    8. Signature

    :


    9. Date

    :

    2021-09-10

    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: DSV Air & Sea NV

    , Bedrijvenzone Machelen Cargo 829A, Machelen, 1830, Belgium   




    1. MEDICINAL PRODUCTS

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

       1.3. without a Marketing Authorisation in the EEA and intended for exportation


    2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

       2.2. Holding 


    3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

       3.3. Cold chain products(requiring low temperature handling) 




    Any restrictions or clarifying remarks (for all users):  3.3.: Authorized temperature for the cold chain : 2-8°C

    3.3.: Toegestane temperatuur voor de koude bewaring : 2-8°C


    Name and address of the site: DSV Air & Sea NV

    , Straatsburgdok-Zuidkaai 6, Antwerpen, 2030, Belgium   




    1. MEDICINAL PRODUCTS

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

       1.3. without a Marketing Authorisation in the EEA and intended for exportation


    2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

       2.2. Holding 


    3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

       3.3. Cold chain products(requiring low temperature handling) 




    Any restrictions or clarifying remarks (for all users):  3.3.: Authorized temperature for the cold chain : 2-8°C

    3.3.: Toegestane temperatuur voor de koude bewaring : 2-8°C








    Reason for Withdrawing:

    old

    old








    Union Format for a Wholesale Distribution Authorisation

    1896 H


    Page 1





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