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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2025-06-13
    		•
    RTF Template


    Federal Agency For Medicines And Health Products

    UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

    Human medicinal products


    1. Authorisation Number

    :

    11 H

    2. Name of Authorisation Holder

    :

    Prothya Biosolutions Belgium

    (ORG-100040470 / LOC-100066454)

    3. Address(es) of Site(s)

    :

    Hanenstraat 148, Buggenhout, 9255, Belgium 




    4. Legally registered address of Authorisation Holder

    :

    De Tyraslaan 109, Brussels, 1120

    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

    :

    2024-02-21

    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: Prothya Biosolutions Belgium

    (ORG-100016221 / LOC-100024995)

    , Hanenstraat 148, Buggenhout, 9255, Belgium   



    Human medicinal products


    1. MEDICINAL PRODUCTS

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

    2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

       2.2. Holding 


    3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

         3.1.2. Medicinal products derived from blood 

       3.3. Cold chain products(requiring low temperature handling) 




    Any restrictions or clarifying remarks (for all users):  3.3 Authorized temperature for the cold chain : ≤ -18 °C

    3.3 Toegestane temperatuur voor de koude bewaring : ≤ -18 °C






    Reason for Withdrawing:

    WDA withdrawn requested by firm







    Union Format for a Wholesale Distribution Authorisation

    11 H


    Page 1





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