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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2025-05-29
    		•
    RTF Template


    Agency For Medicinal Products And Medical Devices Of The Republic Of Slovenia

    UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

    Human medicinal products


    1. Authorisation Number

    :

    801-36/2024-5

    2. Name of Authorisation Holder

    :

    Astellas Pharma trzenje in distribucija farmacevtskih izdelkov d.o.o.

    (ORG-100005275 / LOC-100001895)

    3. Address(es) of Site(s)

    :

    Smartinska Cesta 53, Ljubljana, 1000, Slovenia 




    4. Legally registered address of Authorisation Holder

    :

    Smartinska Cesta 53, Ljubljana, 1000, Slovenia

    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

    :

    2024-09-27

    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: Astellas Pharma trzenje in distribucija farmacevtskih izdelkov d.o.o.

    (ORG-100005275 / LOC-100001895)

    , Smartinska Cesta 53, Ljubljana, 1000, Slovenia   



    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 

       2.4. Export 

       2.5. Other activities(s): Entry of medicinal products from EU to RS; Outwards of medicinal products from RS to EU


    3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

       3.3. Cold chain products(requiring low temperature handling) 




    Any restrictions or clarifying remarks (for all users):  Warehouse at Kemofarmacija, veletrgovina za oskrbo zdravstva, d.d., Cesta na Brdo 100, Ljubljana, 1000, Slovenija






    Reason for Withdrawing:

    New WDA.







    Union Format for a Wholesale Distribution Authorisation

    801-36/2024-5


    Page 1





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