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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2025-07-28
    		•
    RTF Template


    An tÚdarás Rialála Táirgí Sláinte

    UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION


    1. Authorisation Number

    :

    W12639/00001

    2. Name of Authorisation Holder

    :

    Ascot Laboratories (Ireland) Limited

    3. Address(es) of Site(s)

    :

    Westcoast House, Belgard Road, Tallaght, Dublin, -, D24 Y6DF, Ireland 




    4. Legally registered address of Authorisation Holder

    :

    The Georgian Collection, 12 Merrion Square North, Dublin 2, -, D02 H798, 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

    :

    2021-04-01

    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: Ascot Laboratories (Ireland) Limited

    , Westcoast House, Belgard Road, Tallaght, Dublin, -, D24 Y6DF, Ireland   




    1. MEDICINAL PRODUCTS

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

       1.2. without a Marketing Authorisation in the EEA and intended for EEA market

       1.3. without a Marketing Authorisation in the EEA and intended for exportation

    2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

       2.1. Procurement 

       2.3. Supply 


    3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

       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 products 3.4.2 Medicinal products for general sale 3.4.4 Unauthorised medicinal products 3.4.11 Exempt medicinal products






    Reason for Withdrawing:

    Superseded







    Union Format for a Wholesale Distribution Authorisation

    W12639/00001


    Page 1





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