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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2024-11-26
    		•
    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

    :

    801-42/2024-4

    2. Name of Authorisation Holder

    :

    PROMED trgovanje in trzenje z medicinskim materialom d.o.o.

    (ORG-100015369 / LOC-100068221)

    3. Address(es) of Site(s)

    :

    Leskoskova Cesta 9 E, Ljubljana, 1000, Slovenia 




    4. Legally registered address of Authorisation Holder

    :

    Leskoskova Cesta 9 E, 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: PROMED trgovanje in trzenje z medicinskim materialom d.o.o.

    (ORG-100015369 / LOC-100068221)

    , Leskoskova Cesta 9 E, 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

         3.1.1. Narcotic or psychotropic products 

         3.1.2. Medicinal products derived from blood 

         3.1.3. Immunological medicinal products 

       3.3. Cold chain products(requiring low temperature handling) 




    Any restrictions or clarifying remarks (for all users):  WDA is valid until 31. 10. 2024.

    Warehouse at:
    - PROMED trgovanje in trženje z medicinskim materialom, d. o. o., Leskoškova cesta 9D, 1000 Ljubljana
    - Medical Intertrade d.o.o., Brodišče 12, 1236 Trzin






    Reason for Withdrawing:

    New WDA.







    Union Format for a Wholesale Distribution Authorisation

    801-42/2024-4


    Page 1





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