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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2025-03-25
    		•
    RTF Template


    National Center For Public Health And Pharmacy

    UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

    Human medicinal products


    1. Authorisation Number

    :

    HU-D-AIRP

    2. Name of Authorisation Holder

    :

    Airpharm Hungary Kft.

    (ORG-100038671 / LOC-100060745)

    3. Address(es) of Site(s)

    :

    Lorinci Ut 61, Vecses, 2220, Hungary 




    4. Legally registered address of Authorisation Holder

    :

    Lorinci Ut 61, Vecses, 2220

    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

    :

    2023-11-14

    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: Airpharm Hungary Kft.

    (ORG-100038671 / LOC-100060745)

    , Lorinci Ut 61, Vecses, 2220, 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

       3.3. Cold chain products(requiring low temperature handling) 




    Any restrictions or clarifying remarks (for all users):  Authorized Wholesale Distribution Operation

    Room temperature store-house (15-25°C) storage locations
    Cold chain store-house (2-8°C) storage locations

    Name(s) of responsible person(s)   Diploma No.
    Dr. Takács Márta                96/1987  (pharmacist)






    Reason for Withdrawing:

    new WDA was given







    Union Format for a Wholesale Distribution Authorisation

    HU-D-AIRP


    Page 1





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