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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2024-10-09
    		•
    RTF Template


    State Institute for Drug Control

    UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION


    1. Authorisation Number

    :

    S136/0506/DIS 406

    2. Name of Authorisation Holder

    :

    Max-Pharm s.r.o.

    3. Address(es) of Site(s)

    :

    Chebská 1902/128, Aš, 352 01, Czech Republic 




    4. Legally registered address of Authorisation Holder

    :

    Chebská 1902/128, Aš, 352 01, 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

    :

    2006-07-12

    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: Max-Pharm s.r.o.

    , Chebská 1902/128, Aš, 352 01, Czech Republic   




    1. MEDICINAL PRODUCTS

       1.1. with a Marketing Authorisation 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

         3.1.3. Immunological medicinal products 

       3.3. Cold chain products(requiring low temperature handling) 




    Any restrictions or clarifying remarks (for all users):  site was closed 2009-08-06

    sklad byl uzavřen 6.8.2009



    *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

    S136/0506/DIS 406


    Page 1





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