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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2026-04-22
  • RTF Template


    Federal Agency For Medicines And Health Products

    UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

    Human medicinal products


    1. Authorisation Number

    :

    1574 H

    2. Name of Authorisation Holder

    :

    Pharma Base

    (ORG-100015901 / LOC-100024633)

    2.a. Alternative name of authorisation holder (optional)

    :

    Pharma Base N.V.

    3. Address(es) of Site(s)

    :

    Seinhuisstraat 7 Bus 1, Genk, 3600, Belgium 

    3.a. Additional details on units inspected of site(s) address(es) (optional) (All authorised sites should be listed if not covered by separate authorisations)

    :

    Bus 1-2 




    4. Legally registered address of Authorisation Holder

    :

    Seinhuisstraat 7 Bus 1, Genk, Limburg, 3600

    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

    :

    2026-03-23

    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: Pharma Base N.V.

    (ORG-100015901 / LOC-100024633)

    , Seinhuisstraat 7 Bus 1, Genk, 3600, Belgium   


    Additional details on units inspected of site(s) address(es) (optional) (All authorised sites should be listed if not covered by separate authorisations): Bus 1-2


    Human medicinal products


    1. MEDICINAL PRODUCTS

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


    2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

       2.2. Holding 

       2.3. Supply 


    3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

       3.1. Narcotic or psychotropic products** 

       3.2. Products requiring low temperature handling 

         3.2.1. Temperatures between 2 to 8 °C 





    **Without prejudice to further authorisations as may be required according to national legislation.






    Reason for Withdrawing:

    due to inspector note








    Union Format for a Wholesale Distribution Authorisation

    1574 H


    Page 1





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