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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2025-04-23
    		•
    RTF Template


    Norwegian Medical Products Agency

    UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

    Human medicinal products


    1. Authorisation Number

    :

    25/08662-4

    2. Name of Authorisation Holder

    :

    Norwegian Institute Of Public Health

    (ORG-100025050 / LOC-100039882)

    3. Address(es) of Site(s)

    :

    Myrens Verksted 6 J, Oslo, 0473, Norway 




    4. Legally registered address of Authorisation Holder

    :

    Lovisenberggata 8, Oslo, 0456, 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

    :

    2025-04-10

    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: Norwegian Institute Of Public Health

    (ORG-100025050 / LOC-100078340)

    , Myrens Verksted 6 J, Oslo, 0473, Norway   



    Human 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) Direct distribution to professional end-users


    3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

       3.2. Products requiring low temperature handling 

         3.2.1. Temperatures between 2 to 8 °C 

         3.2.2. Other temperatures: (please specify) Below minus 15 °C

       3.3. Other products: (please specify here or make a reference to Annex 5) Med. prod. derived from blood | Immunological med. prod. | Storage of unrel. vaccines in quarantine




    Any restrictions or clarifying remarks (for all users):  Section 1.2 applies only to: 1) 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 who have been granted such exemption. 2) Monkeypox vaccine exempted from requirement for an MA, and procured from Bavarian Nordic A/S, Denmark, through the European Commision's Directorate HERA. | Section 2.2 also applies to holding on behalf of other companies (third party storage). Third party storage applies only to Covid19 vaccines. | Section 2.4 only applies to Covid19 vaccines. | Section 2.5 applies to the delivery of vaccines, immunoglobulins and sera to health establish., professional end-users and hospitals. This includes requisition via subsidized prescript.| The authorisation also applies to a site at Vitusapotek Jernbanetorget, Jernbanetorget 4b, OSLO, NO-0154, Norway. For more details regarding this site, see current WDA.



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






    Reason for Withdrawing:

    Replaced by updated version.







    Union Format for a Wholesale Distribution Authorisation

    25/08662-4


    Page 1





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