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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2025-11-21
  • RTF Template


    Landesamt Fuer Soziale Dienste Schleswig Holstein

    UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

    Human medicinal products


    1. Authorisation Number

    :

    DE_SH_01_WDA_2023_0018

    2. Name of Authorisation Holder

    :

    Dental Bauer GmbH

    (ORG-100034543 / LOC-100054788)

    3. Address(es) of Site(s)

    :

    Kronshagener Weg 105, Schreventeich, Kiel, Schleswig-Holstein, 24116, Germany 




    4. Legally registered address of Authorisation Holder

    :

    Ernst-Simon-Strasse 12, Derendingen, Tuebingen, Baden-Wuerttemberg, 72072

    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

    :

    2023-12-12

    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: Dental Bauer GmbH

    (ORG-100034543 / LOC-100078094)

    , Kronshagener Weg 105, Schreventeich, Kiel, Schleswig-Holstein, 24116, Germany   



    Human medicinal products


    1. MEDICINAL PRODUCTS

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


    2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

       2.1. Procurement 

       2.3. Supply 



    Any restrictions or clarifying remarks (for all users):  Re 1: Finished medicinal products for
    dentists in accordance with § 47 Para. 1 No. 7 AMG.
    Outsourced activities: Storage of medicinal products
    Contract company:
    Dental-Union GmbH
    Site address:
    Gutenbergring 7-9, 63110 Rodgau, Germany
    GLS Logistics GmbH & Co Dental Handel KG
    Falderbaumstraße 7b, 34123 Kassel, Germany

    Zu 1.: Fertigarzneimittel für Zahnärzte nach § 47 Abs. 1 Nr. 7 AMG
    Ausgegliederte Tätigkeiten: Lagerung der Arzneimittel
    Beauftragte Firmen:
    Dental-Union GmbH
    Betriebsstätte:
    Gutenbergring 7-9, 63110 Rodgau
    GLS Logistik GmbH & Co Dental Handel KG
    Falderbaumstraße 7b, 34123 Kassel








    Reason for Withdrawing:

    Deregistration of pharmaceutical wholesaler








    Union Format for a Wholesale Distribution Authorisation

    DE_SH_01_WDA_2023_0018


    Page 1





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