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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2025-07-02
  • RTF Template


    Norwegian Medicines Agency

    UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION


    1. Authorisation Number

    :

    7147-1

    2. Name of Authorisation Holder

    :

    Salfarm Scandinavia AS

    3. Address(es) of Site(s)

    :

    Fridtjof Nansens plass 4, OSLO, NO-0160, Norway 




    4. Legally registered address of Authorisation Holder

    :

    Fridtjof Nansens plass 4, OSLO, NO-0160, Norway

    5. Scope of authorisation

    :

    ANNEX 1

    6. Legal basis of authorisation

    :


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

    :

    Confidential, Confidential

    8. Signature

    :


    9. Date

    :

    2021-01-22

    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: Salfarm Scandinavia AS

    , Fridtjof Nansens plass 4, OSLO, NO-0160, Norway   




    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 

       2.3. Supply 


    3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

         3.1.1. Narcotic or psychotropic products 

         3.1.3. Immunological medicinal products 

       3.3. Cold chain products(requiring low temperature handling) 

       3.4. Other products: Free samples of medicinal products




    Any restrictions or clarifying remarks (for all users):  Medicinal products for use in animals only. | Section 1.2 covers medicinal product BotVax B vet exempted from marketing authorisation and approved for
    named patient use by the Norwegian Medicines Agency. Sale of Such products is restricted to patient in
    Norway only.
    Regarding BotVax B vet manufactured in the United States and imported from Denmark: Pursuant to the
    Norwegian regulation relating to the manufacture and imported of pharmaceuticals, section 3-1, last
    paragraph, this is accepted as an exemption from the regulation`s section 3-6, second paragraph.








    Reason for Withdrawing:

    Replaced by updated version.








    Union Format for a Wholesale Distribution Authorisation

    7147-1


    Page 1





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