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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2026-06-23
    		•
    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_120_3

    2. Name of Authorisation Holder

    :

    Symatese Aesthetics

    (ORG-100054081 / LOC-100095675)

    3. Address(es) of Site(s)

    :

    Lotissement Le Fief D Outreville, 8 Rue Emile Louyot, Bornel, 60540, France 




    4. Legally registered address of Authorisation Holder

    :

    Lotissement Le Fief D Outreville, 8 Rue Emile Louyot, Bornel, 60540

    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

    :

    2025-05-09

    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: Symatese Aesthetics

    (ORG-100054081 / LOC-100095675)

    , Lotissement Le Fief D Outreville, 8 Rue Emile Louyot, Bornel, 60540, France   



    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*

    2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

       2.2. Holding 

       2.3. Supply 

       2.4. Export 

       2.5. Other activities(s): (please specify) Exploitation


    3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

       3.2. Products requiring low temperature handling 

         3.2.1. Temperatures between 2 to 8 °C 




    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, 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;
    only storage is limited to the categories mentioned in 3.

    Signatory: Mrs Bénédicte Bertholom, deputy director - Inspection division.
    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, 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 ;
    seul le stockage est limité aux catégories citées en 3.

    Signataire : Mme Bénédicte Bertholom, directrice adjointe - Direction de l'inspection.
    L'ANSM ne délivre pas de copie papier de cette autorisation.



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






    Reason for Withdrawing:

    replaced by Decision 2026_073_3

    remplacée par la décision 2026_073_3







    Union Format for a Wholesale Distribution Authorisation

    2025_120_3


    Page 1





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