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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2025-04-09
    		•
    RTF Template


    Chief Pharmaceutical Inspectorate

    UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

    Human medicinal products


    1. Authorisation Number

    :

    GIF-N-411/715-1/MSH/13

    2. Name of Authorisation Holder

    :

    Farmak International Sp. z o.o.

    (ORG-100014384 / LOC-100020290)

    3. Address(es) of Site(s)

    :

    Piłsudskiego 141, Łódź, łódzkie, 92-318, Poland 




    4. Legally registered address of Authorisation Holder

    :

    Aleja Jana Pawla II 22, Warsaw, 00-133

    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

    :

    2024-01-26

    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: Hurtownia farmaceutyczna

    , Piłsudskiego 141, Łódź, łódzkie, 92-318, Poland   



    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) 

       3.4. Other products: 3.4.1-3.4.5










    Reason for Withdrawing:

    This WDA authorisation is no longer valid. It has historical value.

    To zezwolenie nie jest już aktualne. Ma wartość historyczną.







    Union Format for a Wholesale Distribution Authorisation

    GIF-N-411/715-1/MSH/13


    Page 1





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