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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2025-11-26
  • RTF Template


    Norwegian Medical Products Agency

    UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

    Human medicinal products


    1. Authorisation Number

    :

    25/03738-4

    2. Name of Authorisation Holder

    :

    Rema Distribusjon Norge AS

    (ORG-100016934 / LOC-100058645)

    3. Address(es) of Site(s)

    :

    Myraasdalen 15, Vinterbro, 1407, Norway 




    4. Legally registered address of Authorisation Holder

    :

    Myraasdalen 15, Vinterbro, 1407, 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

    :

    2025-04-01

    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: Rema Distribusjon Norge AS

    (ORG-100016934 / LOC-100058645)

    , Myraasdalen 15, Vinterbro, 1407, Norway   



    Human medicinal products


    1. MEDICINAL PRODUCTS

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


    2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

       2.1. Procurement 

       2.2. Holding 

       2.3. Supply 

       2.5. Other activities(s): (please specify) Only sale of medicinal products outside pharmacies (LUA outlet)



    Any restrictions or clarifying remarks (for all users):  The authorisation only applies to medicinal products permitted sold outside pharmacies (LUA), cf. Regulations of 14 August 2003 on sale etc. of certain over-the-counter medicinal products outside pharmacies.








    Reason for Withdrawing:

    Replaced by a updated version








    Union Format for a Wholesale Distribution Authorisation

    25/03738-4


    Page 1





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