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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2025-08-01
    		•
    RTF Template


    National Centre For Public Health And Pharmacy

    UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

    Human medicinal products


    1. Authorisation Number

    :

    HU-D-ATLA

    2. Name of Authorisation Holder

    :

    Atlas Pharma Kft.

    (ORG-100038672 / LOC-100096646)

    3. Address(es) of Site(s)

    :

    Erdomenti Ut 3, Budapest XV, 1152, Hungary 




    4. Legally registered address of Authorisation Holder

    :

    Erdomenti Ut 3, Budapest XV, 1152

    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

    :

    2025-05-21

    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: Atlas Pharma Kft.

    (ORG-100038672 / LOC-100096646)

    , Erdomenti Ut 3, Budapest XV, 1152, 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

       3.1. Narcotic or psychotropic products** 

       3.2. Products requiring low temperature handling 

         3.2.1. Temperatures between 2 to 8 °C 

       3.3. Other products: (please specify here or make a reference to Annex 5) see in restriction part.




    Any restrictions or clarifying remarks (for all users):  2. Authorised Wholesale Distribution Operation
    2.2.1 Holding:  
    Room temperature storehouse Ground floor (15-25°C)
    N-001-A-1 to N-086-G-1
    Room temperature storehouse gallery (15-25°C)
    Psychoactive storage: F-300-A-1 to  F-304-E-1
    Narcotic storehouse: Q-300-A-1 to Q-405-A-1
    2.2.2 Cold chain storehouse (2-8 °C) HK01: H-400-A-1 to H-417-D-3, NA: H-900-A-1 to H-900-D-3., HK02

    3. Medicinal products with additional requirements
    3.3 Other products
    3.3.1 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 is:
    Kovácsné dr. Szlatinai Mária          111/1994 (pharmacist)
    Dr Kispál Barna János                       1/2005 (pharmacist)



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

    **Without prejudice to further authorisations as may be required according to national legislation.






    Reason for Withdrawing:

    new one issued







    Union Format for a Wholesale Distribution Authorisation

    HU-D-ATLA


    Page 1





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