Thu 22 Oct 2026 19:55:47 BST
Search Company
*

Active Substance
New Active Substance
Search Site
--
*

Create Site
--
*
*
*
*
*
*
Update Site
Current data stored in EudraGMDP databaseCurrent data stored in OMS
--
Characters remaining:4000/4000
New Active Substance Importation
Active Substance*
Active Substance (English):
Active Substance (NL):
NCA Reference Key:
3rd Country Manufacturer
3rd Country ManufacturerOMS Location IdentifierOMS Organisation IdentifierLegal AddressNCA Reference KeyConfidentialEditDelete
No records found.

3rd Country Distributor
3rd Country DistributorOMS Location IdentifierOMS Organisation IdentifierLegal AddressNCA Reference KeyConfidentialEditDelete
No records found.

Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2025-07-09
  • 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_146_5

    2. Name of Authorisation Holder

    :

    Compagnie D'Exploitation Et De Repartition Pharmaceutiques De Rouen

    (ORG-100025161 / LOC-100055339)

    3. Address(es) of Site(s)

    :

    Boulevard De La Liane, Boulogne Sur Mer, 62200, France 




    4. Legally registered address of Authorisation Holder

    :

    39 Rue Des Augustins, Rouen, 76000

    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

    :

    2022-06-10

    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 Pharmaceutiques De Rouen

    (ORG-100025161 / LOC-100041725)

    , Boulevard De La Liane, Boulogne Sur Mer, 62200, 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

       2.1. Procurement 

       2.2. Holding 

       2.3. Supply 

       2.4. Export 


    3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

         3.1.1. Narcotic or psychotropic products 

         3.1.2. Medicinal products derived from blood 

         3.1.3. Immunological medicinal products 

         3.1.4. Radiopharmaceuticals (including radionuclide kits) 

       3.2. Medicinal gases 

       3.3. Cold chain products(requiring low temperature handling) 




    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 Florence Descamps-Delesalle, head of 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 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_019_5

    remplacée par l'autorisation 2025_019_5








    Union Format for a Wholesale Distribution Authorisation

    2022_146_5


    Page 1





    Loading, please wait