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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2025-01-14
    		•
    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

    :

    801-13/2024-5

    2. Name of Authorisation Holder

    :

    MESSER SLOVENIJA podjetje za proizvodnjo in distribucijo tehnicnih plinov d.o.o.

    (ORG-100001619 / LOC-100008379)

    3. Address(es) of Site(s)

    :

    Jugova Ulica 20, Ruse, 2342, Slovenia 




    4. Legally registered address of Authorisation Holder

    :

    Jugova Ulica 20, Ruse, 2342

    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

    :

    2024-04-22

    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: MESSER SLOVENIJA podjetje za proizvodnjo in distribucijo tehnicnih plinov d.o.o.

    (ORG-100001619 / LOC-100008379)

    , Jugova Ulica 20, Ruse, 2342, Slovenia   



    Human medicinal products


    1. MEDICINAL PRODUCTS

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

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

    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

       3.2. Medicinal gases 




    Any restrictions or clarifying remarks (for all users):  Warehouse at:
    -MESSER SLOVENIJA d.o.o., Brnčičeva ulica 27, Ljubljana – Črnuče,1231, Slovenia
    -MESSER SLOVENIJA d.o.o., Jugova ulica 20, Ruše, 2342, Slovenia
    -MESSER SLOVENIJA d.o.o., Na pristavi 2, Šempeter pri Gorici, 5290, Slovenia
    -MESSER SLOVENIJA d.o.o., Perhavčeva 29, Maribor, 2000, Slovenia
    -MESSER SLOVENIJA d.o.o., Dobja vas 125 F, Ravne na Koroškem, 2390, Slovenia
    -MESSER SLOVENIJA d.o.o., Leskovec 15, Celje, 3000, Slovenia
    -MESSER SLOVENIJA d.o.o., Cesta svobode 31, Brežice, 8250, Slovenia
    -MESSER SLOVENIJA d.o.o., Nemčavci 69, Murska Sobota, 9000, Slovenia
    -MESSER SLOVENIJA d.o.o., DC Novo Mesto, Gosjakova ulica 1, Novo Mesto, 8000, Slovenia

    WDA is valid until 1. 1. 2028.






    Reason for Withdrawing:

    New WDA.







    Union Format for a Wholesale Distribution Authorisation

    801-13/2024-5


    Page 1





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