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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2025-09-17
    		•
    RTF Template


    Norwegian Medical Products Agency

    UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

    Human medicinal products and Veterinary medicinal products


    1. Authorisation Number

    :

    25/03459-4

    2. Name of Authorisation Holder

    :

    VESO AS

    (ORG-100020499 / LOC-100093622)

    3. Address(es) of Site(s)

    :

    Delitoppen 3, Vestby, 1540, Norway 




    4. Legally registered address of Authorisation Holder

    :

    Stortingsgata 2, Oslo, 0158, Norway

    5. Scope of authorisation

    :

    ANNEX 1

    6. Legal basis of authorisation

    :

    Art. 77(1) of Directive 2001/83/EC
    Art. 99 of Regulation (EU) 2019/6

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

    :

    Confidential, Confidential

    8. Signature

    :


    9. Date

    :

    2025-02-13

    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: VESO AS

    (ORG-100020499 / LOC-100064212)

    , Delitoppen 3, Vestby, 1540, Norway   



    Human medicinal products

    Veterinary medicinal products


    1. MEDICINAL PRODUCTS

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

       1.2. without a Marketing Authorisation or registration 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): (please specify) Storage of unreleased med. prod, in quarantine. Direct distribution to professional end users.


    3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

       3.1. Narcotic or psychotropic products** 

         3.2.1. Temperatures between 2 to 8 °C 

         3.2.2. Other temperatures: (please specify) -70 to -90°C, or in liquid nitrogen

       3.3. Other products: (please specify here or make a reference to Annex 5) Invest. med. prod. | Free samples | Med. prod. derived from blood | Immunological prod.




    Any restrictions or clarifying remarks (for all users):  Section 1.2 covers only medicinal products manufactured in, and imported from, PIC/S countries, that requires approval for compassionate use, named patient, according to current rules, cf. Reg. relating to Medicines for Human Use, Section 2-5, and/or medicinal products having been granted exemption from Marketing Authorisation, cf. Reg. relating to Medicines for Human Use, section 2-8 and , cf. Reg. relating to Veterinary Medicinal Products Chapter 4 and Section 11-2, the Act relating to Medicinal Products section 2d, and Regulation 2019//6/EU articles 112-114.
    These medicinal products are restricted to patients and animals in Norway who have been granted such exemption. Section 2.4 covers only export of medicinal products for use in animals. Section 2.5.2 applies to direct distribution to prof. end users and only upon a prescription from a veterinarian or fish health biologist.



    *Art. 5 of Directive 2001/83/EC, Art. 83 of Regulation (EC) 726/2004 and Art. 110 of Regulation 2019/6.

    **Without prejudice to further authorisations as may be required according to national legislation.






    Reason for Withdrawing:

    Replaced by updated version.







    Union Format for a Wholesale Distribution Authorisation

    25/03459-4


    Page 1





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