Sun 25 Oct 2026 01:52:38 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  • The WDA has been withdrawn, withdrawn date is: 2026-03-05
  • 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_045_1_3

    2. Name of Authorisation Holder

    :

    Serb

    (ORG-100001979 / LOC-100007802)

    3. Address(es) of Site(s)

    :

    40 Avenue George V, Paris, 75008, France 




    4. Legally registered address of Authorisation Holder

    :

    40 Avenue George V, Paris, 75008

    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

    :

    2022-04-22

    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: Serb

    (ORG-100001979 / LOC-100007802)

    , 40 Avenue George V, Paris, 75008, 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

         3.1.1. Narcotic or psychotropic products 




    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 Florence Descamps-Delesalle, head of 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, 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 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:

    abrogated by Decision R_2026_007

    abrogée par la décision R_2026_007








    Union Format for a Wholesale Distribution Authorisation

    2022_045_1_3


    Page 1





    Loading, please wait