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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2026-02-06
  • RTF Template


    Landesdirektion Sachsen

    UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

    Human medicinal products


    1. Authorisation Number

    :

    DE_SN_01_WDA_2022_0001

    2. Name of Authorisation Holder

    :

    SMS medipool GmbH

    3. Address(es) of Site(s)

    :

    An der Schachtbahn 18, Markranstädt, 04420, Germany 

    3.a. Additional details on units inspected of site(s) address(es) (optional) (All authorised sites should be listed if not covered by separate authorisations)

    :

    Diese Erlaubnis gilt nur für den Großhandel mit Desinfektionsmitteln und unter § 47 Abs. 1 Nr. 2 lit. c, d oder e AMG aufgeführten Arzneimittelk die weder kühl noch tiefgekühlt zu lagern sind 




    4. Legally registered address of Authorisation Holder

    :

    Therese-Giehse-Platz 2, Germering, 82110

    5. Scope of authorisation

    :

    ANNEX 1

    6. Legal basis of authorisation

    :

    § 52 a Absatz 1 des Gesetzes über den Verkehr mit Arzneimitteln (Arzneimittelgesetz - AMG) in gültiger Fassung

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

    :

    Confidential, Confidential

    8. Signature

    :


    9. Date

    :

    2022-09-14

    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: SMS medipool GmbH

    , An der Schachtbahn 18, Markranstädt, 04420, Germany   


    Additional details on units inspected of site(s) address(es) (optional) (All authorised sites should be listed if not covered by separate authorisations): Diese Erlaubnis gilt nur für den Großhandel mit Desinfektionsmitteln und unter § 47 Abs. 1 Nr. 2 lit. c, d oder e AMG aufgeführten Arzneimittelk die weder kühl noch tiefgekühlt zu lagern sind


    Human medicinal products


    1. MEDICINAL PRODUCTS

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


    2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

       2.1. Procurement 

       2.2. Holding 

       2.3. Supply 


    3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

       3.2. Medicinal gases 




    Any restrictions or clarifying remarks (for all users):  This authorisation for wholesale is limited to disinfectants and medicinal products listed under Section 47 para 1 number 2 letter (c), (d) or (e) of the AMG which do not need to be stored under "cool", "cold" or "freezer" conditions.

    Diese Erlaubnis gilt nur für den Großhandel mit Desinfektionsmitteln und unter § 47 Absatz 1 Nummer 2 Buchstabe c, d oder e AMG aufgeführten Arzneimitteln, die weder kühl noch tiefgekühlt zu lagern sind.








    Reason for Withdrawing:

    Waiver/return of wholesale distribution authorisation due to closure of the business premises in 04420 Markranstädt as of 31 December 2025

    Verzicht auf / Rückgabe der Großhandelserlaubnis wegen Schließung der Betriebsstätte in 04420 Markranstädt zum 31.12.2025








    Union Format for a Wholesale Distribution Authorisation

    DE_SN_01_WDA_2022_0001


    Page 1





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