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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2025-08-13
  • RTF Template


    Medicines Authority

    UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

    Human medicinal products


    1. Authorisation Number

    :

    WL022 (1st Variation)

    2. Name of Authorisation Holder

    :

    Europharma Ltd.

    3. Address(es) of Site(s)

    :

    74 Europharma Medical Centre, Psaila Street, Birkirkara, BKR 9076, Malta 

    Triq l-Industrija, Qormi, N/A, Malta 




    4. Legally registered address of Authorisation Holder

    :

    Catalunya Buildings, Psaila Street, Birkirkara, BKR 9076

    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

    :

    2022-08-16

    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: Europharma Ltd.

    , 74 Europharma Medical Centre, Psaila Street, Birkirkara, BKR 9076, Malta   



    Human 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 

       2.2. Holding 

       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) 




    Name and address of the site: Europharma Ltd

    , Triq l-Industrija, Qormi, N/A, Malta   



    Human 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 

       2.2. Holding 

       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) 










    Reason for Withdrawing:

    superseded








    Union Format for a Wholesale Distribution Authorisation

    WL022 (1st Variation)


    Page 1





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