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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2026-07-07
  • RTF Template


    National Agency For The Safety Of Medicine And Health Products

    UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION


    1. Authorisation Number

    :

    2021_215_1_2_4

    2. Name of Authorisation Holder

    :

    MERCK SANTE

    3. Address(es) of Site(s)

    :

    Zone Industrielle, 10 avenue du Maréchal de Lattre de Tassigny, MEYZIEU, 69330, France 




    4. Legally registered address of Authorisation Holder

    :

    37 rue Saint-Romain, LYON, 69008, France

    5. Scope of authorisation

    :

    ANNEX 1

    6. Legal basis of authorisation

    :


    7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation

    :

    Confidential, Confidential

    8. Signature

    :


    9. Date

    :

    2021-12-21

    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: MERCK SANTE - MEYZIEU

    , Zone Industrielle, 10 avenue du Maréchal de Lattre de Tassigny, MEYZIEU, 69330, France   




    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 


    3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

       3.3. Cold chain products(requiring low temperature handling) 




    Any restrictions or clarifying remarks (for all users):  Dépositaire (Public Health Code Article R.5124-2 4°)
    acting by order and on behalf of:
    - one or more "exploitants" of medicinal products other than investigational medicinal products, generators, kits and precursors (Article L.4211-1 3°),
    - one or more manufacturers or importers of dressing objects or articles presented as complying with the French pharmacopoeia mentioned in Article L.4211-1 2°,
    activity: storage with a view to the wholesale distribution without modification of medicines, products, objects or articles not owned by the company.

    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 dépositaire (code de la santé publique art. R.5124-2 4°) se livrant, d'ordre et pour le compte :
    -d'un ou plusieurs exploitants de médicaments, de générateurs, trousses ou précurseurs (art. L.4211-1 3°),
    -ou d'un ou plusieurs fabricants ou importateurs d'objets de pansement ou articles présentés comme conformes à la Pharmacopée cités à l'art. L.4211-1 2°,
    au stockage de ces médicaments ou produits, objets ou articles dont elle n'est pas propriétaire, en vue de leur distribution en gros et en l'état.

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








    Reason for Withdrawing:

    replaced with
    2026_116_1_2_4

    remplacer par 2026_116_1_2_4








    Union Format for a Wholesale Distribution Authorisation

    2021_215_1_2_4


    Page 1





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