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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2026-10-09
  • RTF Template


    Gobierno Del Pais Vasco

    UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

    Human medicinal products


    1. Authorisation Number

    :

    48810

    2. Name of Authorisation Holder

    :

    Suministros Dentales Anton S.L.

    (ORG-100040522 / LOC-100066558)

    3. Address(es) of Site(s)

    :

    Iberre Kalea 3 Mod 6, Poligono Industrial Zangroiz, Sondika, 48150, Spain 




    4. Legally registered address of Authorisation Holder

    :

    Iberre Kalea 3 Mod 6, Poligono Industrial Zangroiz, Sondika, 48150, Spain

    5. Scope of authorisation

    :

    ANNEX 1

    6. Legal basis of authorisation

    :

    Art. 77(1) of Directive 2001/83/EC
    Art. 99 of Regulation (EU) 2019/6
    Real Decreto 782/2013, de 11 de octubre

    7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation

    :

    Confidential, Confidential

    8. Signature

    :


    9. Date

    :

    2025-02-10

    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: Suministros Dentales Anton S.L.

    (ORG-100040522 / LOC-100066558)

    , Iberre Kalea 3 Mod 6, Poligono Industrial Zangroiz, Sondika, 48150, Spain   



    Human medicinal products


    1. MEDICINAL PRODUCTS

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


    2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

       2.1. Procurement 

       2.2. Holding 

       2.3. Supply 


    3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

       3.3. Other products: (please specify here or make a reference to Annex 5) Almacén monográfico de anestésicos locales / Dedicated warehouse of local anesthetics




    Any restrictions or clarifying remarks (for all users):  Almacén monográfico de medicamentos de uso humano grupo terapéutico N01BB anestésicos locales con indicación de anestesia dental.

    Almacén monográfico de medicamentos de uso humano grupo terapéutico N01BB anestésicos locales con indicación de anestesia dental.








    Reason for Withdrawing:

    This authorisation has been withdrawn.

    Esta autorización ha sido revocada.








    Union Format for a Wholesale Distribution Authorisation

    48810


    Page 1





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