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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2024-11-20
  • RTF Template


    Austrian Federal Office For Safety In Health Care

    UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

    Human medicinal products


    1. Authorisation Number

    :

    483081

    2. Name of Authorisation Holder

    :

    Henry Schein Medical Austria GmbH

    (ORG-100024708 / LOC-100079510)

    3. Address(es) of Site(s)

    :

    Schoenbrunner Strasse 297, Meidling, Vienna, 1120 




    4. Legally registered address of Authorisation Holder

    :

    Schoenbrunner Strasse 297, Meidling, Vienna, 1120

    5. Scope of authorisation (complete for each site under 4)

    :

    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 wholesaling authorisation

    :

    Confidential, Confidential

    8. Signature

    :


    9. Date

    :

    2020-07-09

    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: Henry Schein Medical Austria GmbH

    (ORG-100024708 / LOC-100079510)

    , Schoenbrunner Strasse 297, Meidling, Vienna, 1120   



    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):  Henry Schein Medical Austria GmbH; Keine / none

    Henry Schein Medical Austria GmbH; Keine / none



    *Art 5 of Directive 2001/83/EC or Art 83 of Regulation EC/726/2004

    **Without prejudice to further authorisations as may be required according to national legislation






    Reason for Withdrawing:

    The licence issued in accordance with § 63 para 1 or § 63a para 2 or 3 or § 65 para 1 shall become void if the operating licence holder relinquishes it (austrian medicinal products act).

    The licence issued in accordance with § 63 para 1 or § 63a para 2 or 3 or § 65 para 1 shall become void if the operating licence holder relinquishes it (austrian medicinal products act).








    Union Format for a Wholesale Distribution Authorisation

    483081


    Page 1





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