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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2025-04-24
  • RTF Template


    Federal Agency For Medicines And Health Products

    UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

    Human medicinal products


    1. Authorisation Number

    :

    1594 H

    2. Name of Authorisation Holder

    :

    ALL-in-1

    (ORG-100006002 / LOC-100003316)

    3. Address(es) of Site(s)

    :

    Molenberglei 36, Schelle, 2627, Belgium 




    4. Legally registered address of Authorisation Holder

    :

    Molenberglei 36, Schelle, 2627, Belgium

    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

    :

    2024-02-02

    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: ALL-in-1

    (ORG-100006002 / LOC-100003316)

    , Molenberglei 36, Schelle, 2627, Belgium   



    Human medicinal products


    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

       2.1. Procurement 

       2.2. Holding 

       2.3. Supply 

       2.4. Export 


    3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

       3.3. Cold chain products(requiring low temperature handling) 




    Any restrictions or clarifying remarks (for all users):  1.3.: Warehouse under the authority of the customs.
    3.3.: Authorized temperature for the cold chain: 2-8°C

    1.3.: Opslagplaats onder de bevoegdheid van de douane.
    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

    1594 H


    Page 1





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