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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2026-03-11
    		•
    RTF Template


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

    UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

    Human medicinal products and Veterinary medicinal products


    1. Authorisation Number

    :

    801-50/2024-13

    2. Name of Authorisation Holder

    :

    Grindeks Kalceks farmacevtska druzba d.o.o.

    (ORG-100053458 / LOC-100094466)

    3. Address(es) of Site(s)

    :

    Trdinova Ulica 4, Ljubljana, 1000, Slovenia 




    4. Legally registered address of Authorisation Holder

    :

    Trdinova Ulica 4, Ljubljana, 1000, Slovenia

    5. Scope of authorisation

    :

    ANNEX 1

    6. Legal basis of authorisation

    :

    Art. 77(1) of Directive 2001/83/EC
    Art. 99 of Regulation (EU) 2019/6

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

    :

    Confidential, Confidential

    8. Signature

    :


    9. Date

    :

    2025-03-18

    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: Grindeks Kalceks farmacevtska druzba d.o.o.

    (ORG-100053458 / LOC-100094466)

    , Trdinova Ulica 4, Ljubljana, 1000, Slovenia   



    Human medicinal products

    Veterinary medicinal products


    1. MEDICINAL PRODUCTS

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

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

    2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

       2.1. Procurement 

       2.2. Holding 

       2.3. Supply 

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


    3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

       3.1. Narcotic or psychotropic products** 

       3.2. Products requiring low temperature handling 

         3.2.1. Temperatures between 2 to 8 °C 




    Any restrictions or clarifying remarks (for all users):  Warehouse at Salus, Veletrgovina, d.o.o., Litostrojska cesta 46A, 1000 Ljubljana until 8. 11. 2027

    WDA is valid until 8. 11. 2027



    *Art. 5 of Directive 2001/83/EC, Art. 83 of Regulation (EC) 726/2004 and Art. 110 of Regulation 2019/6.

    **Without prejudice to further authorisations as may be required according to national legislation.






    Reason for Withdrawing:

    New WDA.







    Union Format for a Wholesale Distribution Authorisation

    801-50/2024-13


    Page 1





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