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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2025-11-14
  • RTF Template


    Agency for Medicinal Products and Medical Devices for Croatia

    UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION


    1. Authorisation Number

    :

    UP/I-530-01/14-01/66; 381-13-04/162-14-02

    2. Name of Authorisation Holder

    :

    MEDICAL INTERTRADE društvo s ograničenom odgovornošću za vanjsku trgovinu i za trgovinu na veliko i malo neprehrambenim proizvodima

    3. Address(es) of Site(s)

    :

    A. G. Matoša 16, Solin, 21210, Croatia 




    4. Legally registered address of Authorisation Holder

    :

    Dr. Franje Tuđmana 3, Sveta Nedelja, 10431, Croatia

    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

    :

    2014-07-07

    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: MEDICAL INTERTRADE d.o.o.

    , A. G. Matoša 16, Solin, 21210, Croatia   




    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

       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

         3.1.1. 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) 

       3.4. Other products: Please see restrictions or clarifying remarks (for all users)




    Any restrictions or clarifying remarks (for all users):  Medicinal products from section 3.3 that require cold chain storage are kept at a very cold place 2 to 8 ºC and at a cold place 8 to 15 ºC.

    Medicinal products from section 3.4. are: Homeopathic products, Vaccines, Parallel wholesale distribution, Parallel imported medicinal products, Traditional herbal medicinal products.








    Reason for Withdrawing:

    Licence withdrawn at the request of the wholesale licence holder, administrative decision act: UP/I-530-03/25-07/07, 381-13-08/382-25-02, dated 4 November 2025.








    Union Format for a Wholesale Distribution Authorisation

    UP/I-530-01/14-01/66; 381-13-04/162-14-02


    Page 1





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