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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2024-12-16
  • RTF Template


    French National Agency for Medicines and Health Products Safety

    UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION


    1. Authorisation Number

    :

    MD 16/251

    2. Name of Authorisation Holder

    :

    OCP REPARTITION

    3. Address(es) of Site(s)

    :

    40 rue de L'Epineuil, BP 9, SAINTES, 17100, France 




    4. Legally registered address of Authorisation Holder

    :

    2 rue Galien, SAINT OUEN, 93400, 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

    :

    2016-08-12

    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: OCP REPARTITION - SAINTES

    , 40 rue de L'Epineuil, BP 9, SAINTES, 17100, 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

       2.1. 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):  This site is authorized as a wholesale distributor. The wholesale distributor shall not export medicinal products when acting by order and on behalf of licensed pharmacists of pharmacy or structures mentioned in article D. 5125-24-16.

    Cet établissement est grossiste-répartiteur. Le grossiste-répartiteur ne doit pas distribuer de médicaments en dehors du territoire national quand il agit d'ordre et pour le compte de pharmaciens titulaires d'officine ou de structures mentionnées à l'article D. 5125-24-16.








    Reason for Withdrawing:

    replaced by Decision 2024_247_5

    remplacée par la décision 2024_247_5








    Union Format for a Wholesale Distribution Authorisation

    MD 16/251


    Page 1





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