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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2026-03-02
    		•
    RTF Template


    Health Products Regulatory Authority

    UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

    Human medicinal products


    1. Authorisation Number

    :

    W12398/00001

    2. Name of Authorisation Holder

    :

    Glaxosmithkline Trading Services Limited

    (ORG-100004045 / LOC-100023139)

    3. Address(es) of Site(s)

    :

    12 Riverwalk, Citywest Business Campus, Dublin 24, D24 YK11, Ireland 




    4. Legally registered address of Authorisation Holder

    :

    12 Riverwalk, Citywest Business Campus, Dublin 24, D24 YK11

    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

    :

    2026-02-10

    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: Glaxosmithkline Trading Services Limited

    (ORG-100004045 / LOC-100023139)

    , 12 Riverwalk, Citywest Business Campus, Dublin 24, D24 YK11, Ireland   



    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*

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

    2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

       2.1. Procurement 

       2.3. Supply 

       2.4. Export 


    3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

       3.2. Products requiring low temperature handling 

         3.2.1. Temperatures between 2 to 8 °C 

       3.3. Other products: (please specify here or make a reference to Annex 5) N/A




    Any restrictions or clarifying remarks (for all users):  Not all contract wholesale distribution sites listed in Annex 2 are authorised to hold all of the medicinal product categories listed in Annex 1. ,3.3.01 Prescription only medicinal products,3.3.02 Medicinal products for general sale,3.3.03 Over the counter medicinal products for sale through pharmacies only,3.3.04 Unauthorised medicinal products,3.3.05 Vaccines,3.3.11 Exempt medicinal products,3.3.12 Biological products,3.3.15 Medicinal products derived from blood,3.3.16 Immunological medicinal products



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






    Reason for Withdrawing:

    Superseeded







    Union Format for a Wholesale Distribution Authorisation

    W12398/00001


    Page 1





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