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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2025-12-01
    		•
    RTF Template


    Icelandic Medicines Agency

    UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

    Veterinary medicinal products


    1. Authorisation Number

    :

    071

    2. Name of Authorisation Holder

    :

    Dyraheilsa ehf.

    (ORG-100049356 / LOC-100083957)

    3. Address(es) of Site(s)

    :

    Stadartungu 604, Akureyri, 6515, Iceland 




    4. Legally registered address of Authorisation Holder

    :

    Stadartungu 604, Akureyri, 6515, Iceland

    5. Scope of authorisation

    :

    ANNEX 1

    6. Legal basis of authorisation

    :

    Art. 99 of Regulation (EU) 2019/6

    7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation

    :

    Confidential, Confidential

    8. Signature

    :


    9. Date

    :

    2024-07-17

    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: Dyraheilsa ehf.

    (ORG-100049356 / LOC-100083957)

    , Stadartungu 604, Akureyri, 6515, Iceland   



    Veterinary medicinal products


    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 

       2.3. Supply 


    3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

         3.1.1. Narcotic or psychotropic products 

         3.1.3. Immunological medicinal products 

       3.3. Cold chain products(requiring low temperature handling) 




    Any restrictions or clarifying remarks (for all users):  1.2 Sale (Supply) of veterinary medicinal products exempted from MA by the Icelandic Medicines Agency is only approved for animals in Iceland.

    * Art 10 of The Icelandic veterinary medicinal product Act No 14/2022






    Reason for Withdrawing:

    Updated WDA issued.







    Union Format for a Wholesale Distribution Authorisation

    071


    Page 1





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