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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2025-09-08
  • 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

    :

    2022_259_1_2_3_4

    2. Name of Authorisation Holder

    :

    Creapharm Industry

    (ORG-100011783 / LOC-100018312)

    3. Address(es) of Site(s)

    :

    29 Rue Leon Faucher, Reims, 51100, France 




    4. Legally registered address of Authorisation Holder

    :

    29 Rue Leon Faucher, Reims, 51100

    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

    :

    2022-11-04

    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: Creapharm Industry

    (ORG-100011783 / LOC-100018312)

    , 29 Rue Leon Faucher, Reims, 51100, 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

       2.2. Holding 

       2.3. Supply 

       2.4. Export 

       2.5. Other activities(s): Exploitation


    3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

       3.3. Cold chain products(requiring low temperature handling) 




    Any restrictions or clarifying remarks (for all users):  -
    Exploitant (Public Health Code Article R.5124-2 n°3°) :
    wholesale distribution, advertising, information, pharmacovigilance, batch follow-up and recall of medicinal products other than investigational medicinal products; may concerns all or part of the medicinal products with additional requirements; only storage is limited to the categories cited in 3;

    Dépositaire (Public Health Code Article R.5124-2 n°4°): storage, wholesale distribution of medicinal products, not owned by the company, by order and on behalf of exploitants of medicinal products or products mentioned in Article L.4211-1 3° or manufacturers or importers of products mentioned in Article L.4211-1 2°.

    Signatory: Mrs Florence Descamps-Delesalle, head of pharmaceutical product inspection and counterfeiting fight department ---  The ANSM does not issue hard copy of this authorisation.
    ---

    Établissement exploitant (code de la santé publique art. R.5124-2 n°3°) : vente en gros ou cession à titre gratuit, publicité, information, pharmacovigilance, suivi et retrait des lots de médicaments autres que les médicaments expérimentaux ; concerne tout ou partie des médicaments ayant des exigences particulières; seul le stockage est limité aux catégories citées en 3.

    Établissement dépositaire (code de la santé publique art. R.5124-2 n°4°) : stockage, distribution en gros et en l'état de médicaments dont il n'est pas propriétaire, d'ordre et pour le compte d'exploitants de médicaments ou de produits cités à l'article L.4211-1 3° ou de fabricants ou importateurs de produits cités à l'article L.4211-1 2°.

    Signataire : Mme Florence Descamps-Delesalle, chef 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 authorisation 2025_225_1_2_3

    remplacée par l'autorisation 2025_225_1_2_3








    Union Format for a Wholesale Distribution Authorisation

    2022_259_1_2_3_4


    Page 1





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