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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2026-02-05
  • RTF Template


    Finnish Medicines Agency

    UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

    Human medicinal products


    1. Authorisation Number

    :

    FIMEA/2023/003651

    2. Name of Authorisation Holder

    :

    Oy Bristol-Myers Squibb (Finland) Ab

    (ORG-100021517 / LOC-100070661)

    3. Address(es) of Site(s)

    :

    Tammasaarenkatu 3, Helsinki, 00180, Finland 




    4. Legally registered address of Authorisation Holder

    :

    Tammasaarenkatu 3, Helsinki, 00180

    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

    :

    2023-06-20

    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: Oy Bristol-Myers Squibb (Finland) Ab

    (ORG-100021517 / LOC-100070661)

    , Tammasaarenkatu 3, Helsinki, 00180, Finland   



    Human medicinal products


    1. MEDICINAL PRODUCTS

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


    2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

       2.1. Procurement 

       2.4. Export 

       2.5. Other activities(s): Export to other EEA countries and distribution of medicinal product samples


    3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

       3.3. Cold chain products(requiring low temperature handling) 

       3.4. Other products: Medicinal product samples




    Any restrictions or clarifying remarks (for all users):  Export outside the EEA is restricted only to medicinal products that are not used in humans or animals.








    Reason for Withdrawing:

    New WDA issued, Authorisation Number: FIMEA/2026/000209-2








    Union Format for a Wholesale Distribution Authorisation

    FIMEA/2023/003651


    Page 1





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