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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2025-07-17
  • RTF Template


    National Centre For Public Health And Pharmacy

    UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

    Human medicinal products


    1. Authorisation Number

    :

    HU-D-PHIQ

    2. Name of Authorisation Holder

    :

    Pharma-IQ Kft.

    (ORG-100049912 / LOC-100087124)

    3. Address(es) of Site(s)

    :

    Karolyi Sandor Ut 121, Budapest XV, 1151, Hungary 




    4. Legally registered address of Authorisation Holder

    :

    Bebo Karoly Utca 1, Budapest III, 1039, Hungary

    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

    :

    2024-12-12

    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: Pharma-IQ Kft.

    (ORG-100049912 / LOC-100087123)

    , Karolyi Sandor Ut 121, Budapest XV, 1151, Hungary   



    Human medicinal products


    1. MEDICINAL PRODUCTS

       1.1. with a Marketing Authorisation or registration in EEA country(s)

       1.2. without a Marketing Authorisation or registration in the EEA and intended for EEA market*

       1.3. without a Marketing Authorisation or registration 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

         3.2.1. Temperatures between 2 to 8 °C 

         3.2.2. Other temperatures: (please specify) Temperatures between 8 to 15 °C

       3.3. Other products: (please specify here or make a reference to Annex 5) detailed in Annex 1 remarks




    Any restrictions or clarifying remarks (for all users):  2.2. Holding:
    2.2.1.Room temperature (15-25°C) store-house
    R3-73-01 -> R3-78-04
    2.2 2. Drugs with special storage conditions (8 -15°C)
    H1-01-03; H1-02-03
    2.2.3 Cold chain (2-8°C) store-house
    GC-01-01- > GC-01-07
    3. Medicinal products with additional requirements :
    3.4 Other products:
    3.4.1 HomeoHomeopathic medicinal products
    3.4.2 Materials for preparation of „magistral formula" (human medicinal products)
    3.4.3 herbal and animal drugs
    3.4.4 Dialysing solutions (s.c. CAPD solutions) applying for continuous ambulant peritoneal dialysis.

    Additional provisions based on national requirements. 

    Name(s) of responsible person(s)                        Diploma No.

    Dr. Soós Andrea                                                   77/1979 (pharmacist)
    Dr. Schalkhammer Márta                                     83/2000 (pharmacist)



    *Art. 5 of Directive 2001/83/EC, Art. 83 of Regulation (EC) 726/2004 and Art. 110 of Regulation 2019/6.






    Reason for Withdrawing:

    Their wholesale activities have been discontinued.

    Megszüntették a nagykereskedelmi tevékenységüket.








    Union Format for a Wholesale Distribution Authorisation

    HU-D-PHIQ


    Page 1





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