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  • The WDA has been withdrawn, withdrawn date is: 2024-10-09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


    National Institute of Pharmacy and Nutrition

    UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION


    1. Authorisation Number

    :

    HU-D-PHAP

    2. Name of Authorisation Holder

    :

    PharmaPool Nagykereskedelmi Korlátolt Felelősségű Társaság

    3. Address(es) of Site(s)

    :

    Lőrinci utca 154. D. ép. 7-es; 17-es és 15-ös számú kapuk, Vecsés, 2220, Hungary 

    Lőrinci út 61. A épület, Vecsés, 2220, Hungary 




    4. Legally registered address of Authorisation Holder

    :

    Árbóc utca 6, Budapest, 1133, Hungary

    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

    :

    2021-07-27

    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: PharmaPool Nagykereskedelmi  Korlátolt Felelősségű Társaság

    , Lőrinci utca 154. D. ép. 7-es; 17-es és 15-ös számú kapuk, Vecsés, 2220, 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 



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

    Additional provisions based on national requirements.

    Name(s) of responsible person(s)             diploma No is:
    Dr. Kopári Zsolt                                      48/1993 (pharmacist)


    Name and address of the site: PharmaPool Nagykereskedelmi Korlátolt Felelősségű Társaság

    , Lőrinci út 61. A épület, Vecsés, 2220, 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):  2. Authorised Wholesale Distribution Operation
    2.2. Holding
    2.2.1. Room temperature (15-25°C) store-house storage
    2.2.2. Cooled temperature (8-15°C) fridge
    2.2.3. Cold temperature (2-8°C) cold chamber


    Additional provisions based on national requirements.

    Name(s) of responsible person(s)             diploma No is:
    Dr. Csiktusnádi-Kiss Gergely Antal            57/1992 (pharmacist)



    *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:

    a new WDA was given







    Union Format for a Wholesale Distribution Authorisation

    HU-D-PHAP


    Page 1





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