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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2025-04-16
  • RTF Template


    Landesamt für Gesundheit und Soziales Mecklenburg-Vorpommern - Arzneimittelüberwachungs- und -prüfstelle

    UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

    Human medicinal products


    1. Authorisation Number

    :

    01.22/410.0410

    2. Name of Authorisation Holder

    :

    Cannaphytica Biomed GmbH

    (ORG-100035263 / LOC-100068740)

    3. Address(es) of Site(s)

    :

    Hagenower Strasse 73, Gartenstadt, Schwerin, Mecklenburg-Western-Pommerania, 19061, Germany 




    4. Legally registered address of Authorisation Holder

    :

    Hagenower Strasse 73, Gartenstadt, Schwerin, Mecklenburg-Western-Pommerania, 19061

    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

    :

    2022-03-23

    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: Cannaphytica Biomed GmbH

    (ORG-100035263 / LOC-100068740)

    , Hagenower Strasse 73, Gartenstadt, Schwerin, Mecklenburg-Western-Pommerania, 19061, 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 

       2.4. Export 

       2.5. Other activities(s): Transport, storage and distribution by commissioned company (see annex 2)Transport, Lagerung und Distribution durch beauftragten Betrieb (siehe Anlage 2)


    3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

         3.1.1. Narcotic or psychotropic products 




    Any restrictions or clarifying remarks (for all users):  ref 1.1: Trade in cannabis products only
    ref 3.1.1:  Subject to authorisation according to para 3 German Narkotic Act

    zu 1.1.: nur Handel mit Cannabisprodukte
    zu 3.1.1: vorbehaltlich einer entsprechenden Erlaubnis nach § 3 Betäubungsmittelgesetz








    Reason for Withdrawing:

    The wholesale company does not fulfil the requirements of good distribution practice in accordance with Article 84 of Directive 2001/83/EC. The wholesale distribution authorisation was ordered to be suspended until 30.05.2025.

    Das Großhandelsunternehmen erfüllt nicht die Anforderungen der guten Vertriebspraxis gemäß Artikel 84 der Richtlinie 2001/83/EG. Für die Großhandelserlaubnis wurde das Ruhen bis zum 30.05.2025 angeordnet.








    Union Format for a Wholesale Distribution Authorisation

    01.22/410.0410


    Page 1





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