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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2025-10-01
    		•
    RTF Template


    Austrian Federal Office For Safety In Health Care

    UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

    Human medicinal products and Veterinary medicinal products


    1. Authorisation Number

    :

    484263

    2. Name of Authorisation Holder

    :

    Engel-Apotheke Mag. Dr. Rebitzer KG

    (ORG-100041842 / LOC-100068993)

    3. Address(es) of Site(s)

    :

    Linzer Gasse 5, Salzburg, 5020, Austria 




    4. Legally registered address of Authorisation Holder

    :

    Linzer Gasse 5, Salzburg, 5020, Austria

    5. Scope of authorisation

    :

    ANNEX 1

    6. Legal basis of authorisation

    :

    Art. 77(1) of Directive 2001/83/EC
    Art. 99 of Regulation (EU) 2019/6

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

    :

    Confidential, Confidential

    8. Signature

    :


    9. Date

    :

    2023-03-09

    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: Engel-Apotheke Mag. Dr. Rebitzer KG

    (ORG-100041842 / LOC-100068993)

    , Linzer Gasse 5, Salzburg, 5020, Austria   



    Human medicinal products

    Veterinary medicinal products


    1. MEDICINAL PRODUCTS

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

    2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

       2.1. Procurement 

       2.2. Holding 

       2.3. Supply 

       2.4. Export 


    3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

         3.2.1. Temperatures between 2 to 8 °C 




    Any restrictions or clarifying remarks (for all users):  ENGEL-APOTHEKE Mag. Dr. Rebitzer KG; Probebetrieb bis: / valid until: 09/2025

    ENGEL-APOTHEKE Mag. Dr. Rebitzer KG; Probebetrieb bis: / valid until: 09/2025






    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

    484263


    Page 1





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