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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2025-04-14
  • 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

    :

    2023_270_3

    2. Name of Authorisation Holder

    :

    InfectoPharm France

    (ORG-100049500 / LOC-100084831)

    3. Address(es) of Site(s)

    :

    685 Rue Juliette Recamier, Chaponnay, 69970, France 




    4. Legally registered address of Authorisation Holder

    :

    685 Rue Juliette Recamier, Chaponnay, 69970

    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

    :

    2023-10-09

    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: InfectoPharm France

    (ORG-100049500 / LOC-100084831)

    , 685 Rue Juliette Recamier, Chaponnay, 69970, France   



    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


    2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

       2.3. Supply 

       2.4. Export 

       2.5. Other activities(s): Exploitation



    Any restrictions or clarifying remarks (for all users):  Etablissement exploitant (code de la santé publique art. R.5124-2 3°)
    Exploitation de médicaments autres que les médicaments expérimentaux, de générateurs, trousses et précurseurs (art. L.4211-1 3°) : vente en gros ou cession à titre gratuit, publicité, information, pharmacovigilance, suivi et retrait des lots; peut concerner tout ou partie des médicaments ayant des exigences particulières

    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.

    Exploitant (Public Health Code Article R.5124-2 3°)
    "Exploitation"of medicinal products other than investigational medicinal products, generators, kits and precursors (Article L.4211-1 3 °): wholesale and distribution free of charge, advertising, information, pharmacovigilance, batch follow-up and recall; may concern all or part of the medicinal products with additional requirements.

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








    Reason for Withdrawing:

    replaced by WDA n°2025_138_3

    remplacée pat la WDA n°2025_138_3








    Union Format for a Wholesale Distribution Authorisation

    2023_270_3


    Page 1





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