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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2025-08-13
  • RTF Template


    Ministry for Health

    UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

    Human medicinal products


    1. Authorisation Number

    :

    2022-04

    2. Name of Authorisation Holder

    :

    Knight Therapeutics Europe S.A.

    (ORG-100042752 / LOC-100070675)

    3. Address(es) of Site(s)

    :

    70 Route D'esch, Luxemburg, 1470, Luxembourg 




    4. Legally registered address of Authorisation Holder

    :

    70 Route D'esch, Luxemburg, 1470

    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

    :

    2022-12-20

    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: Knight Therapeutics Europe S.A.

    (ORG-100042752 / LOC-100070675)

    , 70 Route D'esch, Luxemburg, 1470, Luxembourg   



    Human medicinal products


    1. MEDICINAL PRODUCTS

       1.3. without a Marketing Authorisation in the EEA and intended for exportation


    2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

       2.1. Procurement 

       2.4. Export 









    Reason for Withdrawing:

    Ministerial decree from the 31 July 2025: suspended until new request from said Company for a modification of the terms of its authorization.








    Union Format for a Wholesale Distribution Authorisation

    2022-04


    Page 1





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