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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2025-05-20
    		•
    RTF Template


    An tÚdarás Rialála Táirgí Sláinte

    UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION


    1. Authorisation Number

    :

    W12222/00001

    2. Name of Authorisation Holder

    :

    Takeda Products Ireland Limited

    3. Address(es) of Site(s)

    :

    3013 Lake Drive, Citywest Business Campus, Dublin 24, -, D24PPT3, Ireland 




    4. Legally registered address of Authorisation Holder

    :

    6th Floor, South Bank House, Barrow Street, Dublin 4, -, D04TR29, Ireland

    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

    :

    2018-03-26

    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: Takeda Products Ireland Limited

    , 3013 Lake Drive, Citywest Business Campus, Dublin 24, -, D24PPT3, Ireland   




    1. MEDICINAL PRODUCTS

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

    2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

       2.1. Procurement 

       2.3. Supply 


    3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

         3.1.2. Medicinal products derived from blood 

       3.3. Cold chain products(requiring low temperature handling) 

       3.4. Other products: Please see restrictions or clarifying remarks (for all users).




    Any restrictions or clarifying remarks (for all users):  3.4.1 Prescription only medicinal products3.4.3 Over the counter medicinal products for sale through pharmacies only3.4.13 Advance Therapeutic Medicinal products






    Reason for Withdrawing:

    Superseeded







    Union Format for a Wholesale Distribution Authorisation

    W12222/00001


    Page 1





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