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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2025-11-10
    		•
    RTF Template


    National Institute of Pharmacy and Nutrition

    UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION


    1. Authorisation Number

    :

    HU-D-MESH

    2. Name of Authorisation Holder

    :

    Merck Sharp & Dohme International Services B.V.

    3. Address(es) of Site(s)

    :

    Akron u. 1. Camel Park, Budaörs, 2040, Hungary 




    4. Legally registered address of Authorisation Holder

    :

    Wegalaan 34-36, HOOFDORP (Netherlands), 2132 JC, 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

    :

    2021-05-07

    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: Merck Sharp & Dohme International Services B.V.

    , Akron u. 1. Camel Park, Budaörs, 2040, 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
    2.2.1 Holding:
    Room temperature (15-25°C) store-house
    Cold chain (2-8°C) store-house

    Additional provisions based on national requirements.

    Name of responsible person:                        diploma No is:
    Dr. Szoboszlai Nóra                               14-51/2014. DE GYTK (pharmacist)






    Reason for Withdrawing:

    The WD licence was withdrawn because a new modified licence was issued.







    Union Format for a Wholesale Distribution Authorisation

    HU-D-MESH


    Page 1





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