Mon 2 Nov 2026 12:14:06 BST
Search Company
*

Active Substance
New Active Substance
Search Site
--
*

Create Site
--
*
*
*
*
*
*
Update Site
Current data stored in EudraGMDP databaseCurrent data stored in OMS
--
Characters remaining:4000/4000
New Active Substance Importation
Active Substance*
Active Substance (English):
Active Substance (NL):
NCA Reference Key:
3rd Country Manufacturer
3rd Country ManufacturerOMS Location IdentifierOMS Organisation IdentifierLegal AddressNCA Reference KeyConfidentialEditDelete
No records found.
3rd Country Distributor
3rd Country DistributorOMS Location IdentifierOMS Organisation IdentifierLegal AddressNCA Reference KeyConfidentialEditDelete
No records found.
Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2025-10-01
    		•
    RTF Template


    Norwegian Medical Products Agency

    UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

    Human medicinal products


    1. Authorisation Number

    :

    24/20945-4

    2. Name of Authorisation Holder

    :

    Linde Gas AS

    (ORG-100017351 / LOC-100026147)

    3. Address(es) of Site(s)

    :

    Gamle Leirdals Vei 2, Oslo, 1081, Norway 




    4. Legally registered address of Authorisation Holder

    :

    Gjerdrums Vei 8, Oslo, 0484, Norway

    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

    :

    2024-09-25

    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 AS

    (ORG-100017351 / LOC-100055045)

    , Gamle Leirdals Vei 2, Oslo, 1081, Norway   



    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): Direct distribution to professional end-users


    3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

       3.2. Medicinal gases 




    Any restrictions or clarifying remarks (for all users):  The authorisation only covers medicinal gases. Section 1.2 applies only to medicinal products manufactured in, and imported from, PIC/S countries, that requires approval for compassionate use, named patient, according to current rules.These medicinal products are restricted to patients in Norway, for which such exemption has been granted. Section 2.5 grants the right to perform direct distribution to professional end-users of the medicinal products covered by the authorisation: To nursing homes, hospitals and other prescribers of medicinal products.






    Reason for Withdrawing:

    Replaced by updated version







    Union Format for a Wholesale Distribution Authorisation

    24/20945-4


    Page 1





    Loading, please wait