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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2025-09-11
    		•
    RTF Template


    National Institute of Pharmacy and Nutrition

    UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION


    1. Authorisation Number

    :

    HU-D-WORW

    2. Name of Authorisation Holder

    :

    Wörwag Pharma Kft.

    3. Address(es) of Site(s)

    :

    Akácos, Hrsz.: 0221/12 A1 épület, Fót, 2151, Hungary 




    4. Legally registered address of Authorisation Holder

    :

    Montevideo utca 5., Budapest, 1037, Hungary

    5. Scope of authorisation

    :

    ANNEX 1

    6. Legal basis of authorisation

    :


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

    :

    Confidential, Confidential

    8. Signature

    :


    9. Date

    :

    2020-06-19

    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: Wörwag Pharma Kft.

    , Akácos, Hrsz.: 0221/12 A1 épület, Fót, 2151, Hungary   




    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):  Room temperature (15-25°C) store-house storage locations:
    A001 → A005, A006-B, A006-C, A007-A → A0059-E, B001-A → B0015-A, B001-B → B047-A

    Drugs, which requires special storage, condition (2°C-8°C), storage locations:
    Z001 - Z006

    Name(s) of responsible person(s)

          Dr. Maller László 59/2004 Pharmacist
          Dr. Zalahán Annamária 255/1985 Pharmacist






    Reason for Withdrawing:

    New one issued, new legal address







    Union Format for a Wholesale Distribution Authorisation

    HU-D-WORW


    Page 1





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