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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2026-10-26
  • RTF Template


    National Agency For The Safety Of Medicine And Health Products

    UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

    Human medicinal products


    1. Authorisation Number

    :

    2025_104_7

    2. Name of Authorisation Holder

    :

    Piex Societe Pharmaceutique D Import Export

    (ORG-100035797 / LOC-100056686)

    3. Address(es) of Site(s)

    :

    Zone D Amenagement Concerte Ecoparc 2, 2 Allee De La Butte A Colas, Heudebouville, 27400, France 




    4. Legally registered address of Authorisation Holder

    :

    Batiment A Zone D Activite De Courtaboeuf, 3-7 Avenue Du Cap Horn, Les Ulis, 91940, France

    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

    :

    2025-03-04

    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: Piex Societe Pharmaceutique D Import Export

    (ORG-100035797 / LOC-100094768)

    , Zone D Amenagement Concerte Ecoparc 2, 2 Allee De La Butte A Colas, Heudebouville, 27400, France   



    Human medicinal products


    1. MEDICINAL PRODUCTS

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

       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 



    Any restrictions or clarifying remarks (for all users):  -
    Wholesale distributor for export (Public Health Code Article R.5124-2 7°): purchasing and storage operations with a view to the export without modification, of:
    - medicinal products other than investigational medicinal products,
    - products, objects, articles, generators, kits or precursors mentioned in paragraphs 2° and 3° of Article L. 4211-1,
    - medicinal plants stipulated in paragraph 5° of Article L. 4211-1.

    Signatory: Mrs Solange Solbes, coordinator of pharmaceutical product inspection and counterfeiting fight department
    The ANSM does not issue hard copy of this authorisation.
    ---

    Etablissement distributeur en gros à l'exportation (code de la santé publique art. R.5124-2 7°) se livrant à l'achat et au stockage de médicaments autres que des médicaments expérimentaux, d'objets, articles, générateurs, trousses ou précurseurs mentionnés aux 2° et 3° de l'article L.4211-1, de plantes médicinales mentionnées au 5° de l'article L.4211-1, en vue de leur exportation en l'état.

    Signataire : Mme Solange Solbes, coordinatrice du Pôle inspection des produits pharmaceutiques et lutte contre les fraudes
    L'ANSM ne délivre pas de copie papier de cette autorisation.








    Reason for Withdrawing:

    site closed

    Decision R_2026_060

    fermeture
    decision  R_2026_060








    Union Format for a Wholesale Distribution Authorisation

    2025_104_7


    Page 1





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