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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2025-02-04
  • RTF Template


    Landesdirektion Sachsen LDS

    UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

    Human medicinal products


    1. Authorisation Number

    :

    DE_SN_01/26-5117/287/16

    2. Name of Authorisation Holder

    :

    Deutsche Medizinalcannabis GmbH

    (ORG-100033425 / LOC-100053134)

    3. Address(es) of Site(s)

    :

    Moritzburger Weg 1, Naunhof, Ebersbach, Saxony, 01561, Germany 




    4. Legally registered address of Authorisation Holder

    :

    Moritzburger Weg 1, Naunhof, Ebersbach, Saxony, 01561, Germany

    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

    :

    2022-01-27

    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: Deutsche Medizinalcannabis GmbH

    (ORG-100033425 / LOC-100053134)

    , Moritzburger Weg 1, Naunhof, Ebersbach, Saxony, 01561, Germany   



    Human medicinal products


    1. MEDICINAL PRODUCTS

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

       1.2. without a Marketing Authorisation in the EEA and intended for EEA market


    2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

       2.1. Procurement 

       2.3. Supply 

       2.4. Export 


    3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

         3.1.1. Narcotic or psychotropic products 




    Any restrictions or clarifying remarks (for all users):  This authorisation applies to the wholesale of cannabis products containing THC in the form of cannabis flowers and cannabis oil resin, whereby all activities associated with the physical handling of the medicinal products are carried out by authorised companies.
    Cannabis flowers and cannabis oil resin are bulk medicinal products as starting materials for prescription or ready-to-use medicinal products to be manufactured in pharmacies.

    (Note: at the time the authorisation was entered in the database, the signatory of the original authorisation, Mr Klaus Hartmann, was no longer available for electronic selection. Mr Tim Baumann was therefore selected as his successor in the database).

    Diese Erlaubnis gilt für den Großhandel mit THC-haltigen Cannabisprodukten in Form von Cannabisblüten und Cannabisölharz, wobei alle mit dem physischen Umgang mit den Arzneimitteln verbundenen Tätigkeiten von beauftragten Betrieben durchgeführt werden.
    Bei Cannabisblüten und Cannabisölharz handelt es sich um Bulk-Arzneimittel als Ausgangsstoffe für in Apotheken herzustellende Rezeptur- oder Defekturarzneimittel.

    (Anmerkung: zum Zeitpunkt der Eintragung der Erlaubnis in die Datenbank stand der Unterschriftsgeber der Original-Erlaubnis, Herr Klaus Hartmann, nicht mehr zur elektronischen Auswahl. Daher wurde Herr Tim Baumann als Nachfolger entsprechend in der Datenbank ausgewählt.)








    Reason for Withdrawing:

    has been replaced by a new wholesale distribution authorisation, dated January 10, 2025 (number DE_SN_01_WDA_2025_0003)

    Ist durch eine neue Großhandelserlaubnis, datiert vom 10. Januar 2025 mit der Nummer DE_SN_01_WDA_2025_0003, ersetzt worden.








    Union Format for a Wholesale Distribution Authorisation

    DE_SN_01/26-5117/287/16


    Page 1





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