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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2025-06-24
    		•
    RTF Template


    Bulgarian Drug Agency

    UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION


    1. Authorisation Number

    :

    IV-Р-Т - EU - 137-1

    2. Name of Authorisation Holder

    :

    "ВАКСФАРМА" ЕООД/VAXFARMA EOOD

    3. Address(es) of Site(s)

    :

    район Красно село, ул. "Родопски извор"№30-32/, region Krasno selo, 30-32 Rodopski izvor str., гр. София/Sofia, 1680, Bulgaria 




    4. Legally registered address of Authorisation Holder

    :

    ж.к. "Младост", бл. 73, вх. 7, ет. 8, ап. 24, region Mladost, r.d. Mladost, bl.73, vh.7,et 8, app.24, гр. София/Sofia, 1784, Bulgaria

    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

    :

    2015-02-09

    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: "ВАКСФАРМА" ЕООД/VAXFARMA EOOD

    , район Красно село, ул. "Родопски извор"№30-32/, region Krasno selo, 30-32 Rodopski izvor str., гр. София/Sofia, 1680, Bulgaria   




    1. MEDICINAL PRODUCTS

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

       1.3. without a Marketing Authorisation in the EEA and intended for exportation

    2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

       2.1. Procurement 

       2.2. Holding 

       2.3. Supply 

       2.4. Export 


    3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

         3.1.3. Immunological medicinal products 

       3.3. Cold chain products(requiring low temperature handling) 










    Reason for Withdrawing:

    3OA-0361/20.06.2025

    3OA-0361/20.06.2025







    Union Format for a Wholesale Distribution Authorisation

    IV-Р-Т - EU - 137-1


    Page 1





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