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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2025-04-30
    		•
    RTF Template


    Medicines Authority

    UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

    Human medicinal products


    1. Authorisation Number

    :

    WDL054

    2. Name of Authorisation Holder

    :

    Associated Drug Co. Limited

    (ORG-100008651 / LOC-100073855)

    3. Address(es) of Site(s)

    :

    Triq L-Esportaturi, Zone 1, Central Business District, Birkirkara, CBD 1040, Malta 




    4. Legally registered address of Authorisation Holder

    :

    Triq L-Esportaturi, Zone 1, Central Business District, Birkirkara, CBD 1040

    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

    :

    2022-09-13

    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: Associated Drug Co. Limited

    (ORG-100008651 / LOC-100073855)

    , Triq L-Esportaturi, Zone 1, Central Business District, Birkirkara, CBD 1040, 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

       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 

         3.1.3. Immunological medicinal products 

       3.3. Cold chain products(requiring low temperature handling) 




    Any restrictions or clarifying remarks (for all users):  Wholesale operations are limited to ADC Building Level 0 and Level 1, Triq l-Esportaturi, Zone 1 Central Business District, Birkirkara CBD 1040, Malta






    Reason for Withdrawing:

    WDA was renewed







    Union Format for a Wholesale Distribution Authorisation

    WDL054


    Page 1





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