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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2026-01-14
    		•
    RTF Template


    National Center For Public Health And Pharmacy

    UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

    Human medicinal products


    1. Authorisation Number

    :

    HU-D-SANO

    2. Name of Authorisation Holder

    :

    SANOFI-AVENTIS Zrt.

    (ORG-100001087 / LOC-100070396)

    3. Address(es) of Site(s)

    :

    Building Dc5, Campona Utca 1, Budapest XXII, 1225, Hungary 




    4. Legally registered address of Authorisation Holder

    :

    Vaci Ut 133 E Ep Em 3, Budapest, 1138

    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

    :

    2024-02-15

    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: SANOFI-AVENTIS Zrt.

    (ORG-100001087 / LOC-100001001)

    , Building Dc5, Campona Utca 1, Budapest XXII, 1225, Hungary   



    Human medicinal products


    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

       1.3. without a Marketing Authorisation in the EEA and intended for exportation

    2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

       2.1. Procurement 

       2.2. Holding 

       2.3. Supply 

       2.4. Export 


    3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

         3.1.1. Narcotic or psychotropic products 

         3.1.3. Immunological medicinal products 

       3.3. Cold chain products(requiring low temperature handling) 




    Any restrictions or clarifying remarks (for all users):  2. Authorised Wholesale Distribution Operation:
    2.2 Room temperature (15-25 °C) store-house locations:

    3. Medicinal products with additional requirements:
    3.3.Cold temperature (2-8 °C) store-house locations:

    Name(s) of responsible person(s)    Diploma No.
    Dr. Turbucz Béla                                   93/SE-GYTK-GYO/2017 (Pharmacist)
    Boros Anikó Jolán                                 68/1983 ( Chemical plant engineer)






    Reason for Withdrawing:

    The WD licence was withdrawn because a new modified licence was issued.







    Union Format for a Wholesale Distribution Authorisation

    HU-D-SANO


    Page 1





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