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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2024-11-15
    		•
    RTF Template


    State Institute for Drug Control

    UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION


    1. Authorisation Number

    :

    2816/4/INS/05

    2. Name of Authorisation Holder

    :

    Zdravotnické zásobování Morava, spol. s r.o.

    3. Address(es) of Site(s)

    :

    TEMA, spol. s r.o., Valchařská 36, Brno, 614 00, Czech Republic 




    4. Legally registered address of Authorisation Holder

    :

    Zeiberlichova 34, Brno, 644 00, Czech Republic

    5. Scope of authorisation (complete for each site under 4)

    :

    ANNEX 1

    6. Legal basis of authorisation

    :


    7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation

    :

    Confidential, Confidential

    8. Signature

    :


    9. Date

    :

    2005-04-15

    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: Zdravotnické zásobování Morava, spol. s r.o.

    , TEMA, spol. s r.o., Valchařská 36, Brno, 614 00, Czech Republic   




    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

    2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

       2.1. Procurement 

       2.2. Holding 

       2.3. Supply 


    3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

       3.3. Cold chain products(requiring low temperature handling) 




    Any restrictions or clarifying remarks (for all users):  site was closed 2010-10-31

    sklad byl zrušen 31.10.2010



    *Art 5 of Directive 2001/83/EC or Art 83 of Regulation EC/726/2004

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






    Reason for Withdrawing:

    Annulment







    Union Format for a Wholesale Distribution Authorisation

    2816/4/INS/05


    Page 1





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