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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2025-08-22
  • RTF Template


    National Agency for Medicines and Medical Devices of Romania

    UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION


    1. Authorisation Number

    :

    623D

    2. Name of Authorisation Holder

    :

    FARM GALAN SRL

    3. Address(es) of Site(s)

    :

    Aleea Constantin Brâncuşi nr.3, Mun. Craiova, Jud. Dolj, Cod poştal 200404, Romania 




    4. Legally registered address of Authorisation Holder

    :

    Calea Bucureşti nr. 35, bl. 21D, parter, Mun Craiova, Jud. Dolj, Cod poştal 200465, Romania

    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

    :

    2020-02-11

    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: FARM GALAN SRL

    , Aleea Constantin Brâncuşi nr.3, Mun. Craiova, Jud. Dolj, Cod poştal 200404, Romania   




    1. MEDICINAL PRODUCTS

       1.1. with a Marketing Authorisation in EEA country(s)


    2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

       2.1. Procurement 

       2.3. Supply 


    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 

       3.3. Cold chain products(requiring low temperature handling) 




    Any restrictions or clarifying remarks (for all users):  The current WDA is valid only if the terms of the storage and logistical services agreement (storage, handling, transport) signed with SC MSL LOGISTIC SERVICES DISTRIBUTION SRL.  are complied with.

    rezenta Autorizaţie de distribuţie angro este validă numai respectându-se prevederile contractului de custodie şi prestări servicii logistice (depozitare, manipulare, transport) încheiat cu SC MSL LOGISTIC SERVICES DISTRIBUTION SRL.








    Reason for Withdrawing:

    Suspended








    Union Format for a Wholesale Distribution Authorisation

    623D


    Page 1





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