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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2026-03-09
    		•
    RTF Template


    Bulgarian Drug Agency

    UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

    Human medicinal products


    1. Authorisation Number

    :

    BG/WDA/MP-0393

    2. Name of Authorisation Holder

    :

    Maritsa International Ltd.

    (ORG-100048072 / LOC-100079511)

    3. Address(es) of Site(s)

    :

    Bulevard Maritsa 154, Plovdiv, 4000, Bulgaria 




    4. Legally registered address of Authorisation Holder

    :

    Bulevard Maritsa 154, Plovdiv, 4000

    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

    :

    2023-03-29

    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: Maritsa International Ltd.

    (ORG-100048072 / LOC-100079511)

    , Bulevard Maritsa 154, Plovdiv, 4000, Bulgaria   



    Human medicinal products


    1. MEDICINAL PRODUCTS

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

    2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

       2.1. Procurement 

       2.2. Holding 

       2.3. Supply 

       2.4. Export 


    3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

         3.1.2. 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 address of site is: 4003 Plovdiv, 145 Brezovsko shose Blvd






    Reason for Withdrawing:

    3OA-0147/05.03.2026

    3OA-0147/05.03.2026







    Union Format for a Wholesale Distribution Authorisation

    BG/WDA/MP-0393


    Page 1





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