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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2026-09-28
  • 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_016_5

    2. Name of Authorisation Holder

    :

    COMPAGNIE D'EXPLOITATION ET DE REPARTITION PHARMACEUTIQUE

    (ORG-100025161 / LOC-100055339)

    3. Address(es) of Site(s)

    :

    24 B Rue De La Charmeuse, Bavilliers, 90800, France 




    4. Legally registered address of Authorisation Holder

    :

    39-41 Rue Des Augustins, Rouen, 76000, 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

    :

    2025-03-11

    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: COMPAGNIE D'EXPLOITATION ET DE REPARTITION PHARMACEUTIQUE

    (ORG-100025161 / LOC-100094043)

    , 24 B Rue De La Charmeuse, Bavilliers, 90800, 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

       2.1. Procurement 

       2.2. Holding 

       2.3. Supply 

       2.4. Export 


    3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

       3.1. Narcotic or psychotropic products** 

       3.2. Products requiring low temperature handling 

         3.2.1. Temperatures between 2 to 8 °C 

         3.2.2. Other temperatures: (please specify) freezing - congélation

       3.3. Other products: (please specify here or make a reference to Annex 5) medicinal products derived from blood, immunological medicinal products, medicinal gases  --- médicaments dérivés du sang, médicaments immunologiques, gaz médicinaux




    Any restrictions or clarifying remarks (for all users):  -
    Wholesale distributor (Public Health Code Article R.5124-2 5°)
    Activity: purchasing and storage operations with a view to the wholesale distribution without modification of medicinal products other than investigational medicinal products;
    An activity can also been undertaken by order and on behalf of:
    - licensed pharmacists of pharmacy,
    - or structures mentioned in Article D. 5125-24-16
    for purchasing and storage operations of medicinal products other than investigational medicinal products, except for medicinal products which are refundable by mandatory health insurance schemes, with a view to their wholesale distribution without modification to licensed pharmacists of pharmacy on the national territory only.

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

    ----------

    Établissement grossiste-répartiteur (code de la santé publique art. R.5124-2 5°) se livrant à l'achat et au stockage de médicaments autres que des médicaments expérimentaux, en vue de leur distribution en gros et en l'état ;
    peut également se livrer, d'ordre et pour le compte de pharmaciens titulaires d'officine ou des structures mentionnées à l'article D.5125-24-16, à l'achat et au stockage de médicaments autres que des médicaments expérimentaux, à l'exception des médicaments remboursables par les régimes obligatoires d'assurance maladie, en vue de leur distribution en gros et en l'état et uniquement sur le territoire national.

    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.



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

    **Without prejudice to further authorisations as may be required according to national legislation.






    Reason for Withdrawing:

    replaced by WDA #2026_175_4_5

    remplacée par la WDA n°2026_175_4_5








    Union Format for a Wholesale Distribution Authorisation

    2025_016_5


    Page 1





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