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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2026-01-05
    		•
    RTF Template


    State Institute For Drug Control

    UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

    Human medicinal products


    1. Authorisation Number

    :

    sukls513770/2025

    2. Name of Authorisation Holder

    :

    Emedito s.r.o.

    (ORG-100017790 / LOC-100036519)

    3. Address(es) of Site(s)

    :

    warehouse is in Boženy Němcové 1025/9, Blansko, 678 01, Czechia 




    4. Legally registered address of Authorisation Holder

    :

    J. Lady 1906/16, Blansko, 678 01

    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

    :

    2025-12-16

    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: Emedito s.r.o.

    , warehouse is in Boženy Němcové 1025/9, Blansko, 678 01, Czechia   



    Human medicinal products


    1. MEDICINAL PRODUCTS

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

    2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

       2.1. Procurement 

       2.2. Holding 

       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 










    Reason for Withdrawing:

    annulment







    Union Format for a Wholesale Distribution Authorisation

    sukls513770/2025


    Page 1





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