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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2025-10-23
  • RTF Template


    National Agency For The Safety Of Medicine And Health Products

    UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION


    1. Authorisation Number

    :

    2021_205_3

    2. Name of Authorisation Holder

    :

    MELISANA PHARMA

    3. Address(es) of Site(s)

    :

    8 Avenue des Minimes, VINCENNES, 94300, France 




    4. Legally registered address of Authorisation Holder

    :

    8 avenue des Minimes, VINCENNES, 94300, France

    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

    :

    2021-12-14

    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: MELISANA PHARMA

    , 8 Avenue des Minimes, VINCENNES, 94300, France   




    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):  -
    Exploitant (Public Health Code Article R.5124-2 3°)
    "Exploitation" of medicinal products other than investigational medicinal products : 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: Mr Said Ioughlissen, deputy head of the pharmaceutical product inspection and counterfeiting fight department. The ANSM does not issue hard copy of this authorisation.
    ---

    Etablissement exploitant (code de la santé publique art. R.5124-2 3°)
    Exploitation de médicaments autres que les médicaments expérimentaux,  : 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: M. Said Ioughlissen, chef adjoint 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:

    replaced with 2025_230_3








    Union Format for a Wholesale Distribution Authorisation

    2021_205_3


    Page 1





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