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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2026-05-01
    		•
    RTF Template


    Ministerie van Volksgezondheid Welzijn en Sport

    UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

    Human medicinal products


    1. Authorisation Number

    :

    16270 G

    2. Name of Authorisation Holder

    :

    Neurocrine Netherlands B.V.

    (ORG-100012376 / LOC-100019422)

    3. Address(es) of Site(s)

    :

    Van Heuven Goedhartlaan 935 A, Amstelveen, 1181 LD, Netherlands 




    4. Legally registered address of Authorisation Holder

    :

    Van Heuven Goedhartlaan 935 A, Amstelveen, 1181 LD, Netherlands

    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

    :

    2024-11-18

    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: Neurocrine Netherlands B.V.

    (ORG-100012376 / LOC-100019422)

    , Van Heuven Goedhartlaan 935 A, Amstelveen, 1181 LD, Netherlands   



    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 

       2.3. Supply 

       2.4. Export 




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






    Reason for Withdrawing:

    withdrawn per 1 may 2026

    ingetrokken per 1 mei 2026







    Union Format for a Wholesale Distribution Authorisation

    16270 G


    Page 1





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