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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2026-09-23
  • RTF Template


    State Institute For Drug Control

    UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

    Human medicinal products


    1. Authorisation Number

    :

    D-21/2023/1

    2. Name of Authorisation Holder

    :

    Linde Gas s.r.o.

    (ORG-100002596 / LOC-100009619)

    3. Address(es) of Site(s)

    :

    Tuhovska 3, Vajnory, Bratislava, 831 06, SLOVAKIA 

    Juzna Trieda 1598/82, Juh, Kosice, 040 01, SLOVAKIA 

    Majerska Cesta 3719/36, Majer, Banska Bystrica, 974 01, SLOVAKIA 

    Kraciny 1, Martin, 036 01, SLOVAKIA 




    4. Legally registered address of Authorisation Holder

    :

    Tuhovska 3, Vajnory, Bratislava, 831 06, SLOVAKIA

    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

    :

    2023-10-16

    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: Linde Gas s.r.o.

    (ORG-100002596 / LOC-100009619)

    , Tuhovska 3, Vajnory, Bratislava, 831 06, SLOVAKIA   



    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 


    3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

       3.2. Medicinal gases 




    Name and address of the site: Linde Gas s.r.o.

    (ORG-100002596 / LOC-100086537)

    , Juzna Trieda 1598/82, Juh, Kosice, 040 01, SLOVAKIA   



    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 


    3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

       3.2. Medicinal gases 




    Name and address of the site: Linde Gas s.r.o.

    (ORG-100002596 / LOC-100086442)

    , Majerska Cesta 3719/36, Majer, Banska Bystrica, 974 01, SLOVAKIA   



    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 


    3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

       3.2. Medicinal gases 




    Name and address of the site: Linde Gas s.r.o.

    (ORG-100002596 / LOC-100086466)

    , Kraciny 1, Martin, 036 01, SLOVAKIA   



    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 


    3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

       3.2. Medicinal gases 










    Reason for Withdrawing:

    withdrawal due to the revocation of a permit and the simultaneous issuance of a new permit

    stiahnutie z dôvodu zrušenia povolenia a súčasne vydania nového povolenia








    Union Format for a Wholesale Distribution Authorisation

    D-21/2023/1


    Page 1





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