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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2025-11-25
    		•
    RTF Template


    National Authority Of Medicines And Health Products

    UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

    Human medicinal products


    1. Authorisation Number

    :

    A035/14/H/008/2024

    2. Name of Authorisation Holder

    :

    Lisbomed Especialidades Farmaceuticas Lda.

    (ORG-100020849 / LOC-100093196)

    3. Address(es) of Site(s)

    :

    Rua Quinta Do Pinheiro 5, Alverca Do Ribatejo, 2615-184, Portugal 




    4. Legally registered address of Authorisation Holder

    :

    Alameda Bonifacio Lazaro Lozano 15 2 G, Oeiras, 2780-125, Portugal

    5. Scope of authorisation

    :

    ANNEX 1

    6. Legal basis of authorisation

    :

    Art. 77(1) of Directive 2001/83/EC
    National legal basis of authorisation: Art. 94.º of Decree-law 176/2006, of 30th August.

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

    :

    Confidential, Confidential

    8. Signature

    :


    9. Date

    :

    2024-09-18

    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: Lisbomed Especialidades Farmaceuticas Lda.

    (ORG-100020849 / LOC-100041690)

    , Rua Quinta Do Pinheiro 5, Alverca Do Ribatejo, 2615-184, Portugal   



    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

         3.1.2. Medicinal products derived from blood 

         3.1.3. Immunological medicinal products 

       3.3. Cold chain products(requiring low temperature handling) 




    Any restrictions or clarifying remarks (for all users):  WDA scope activity - Wholesale Distributor.

    Updating of the WDA Header regarding a change in the legal address of the Authorisation Holder.

    Complete site address: Quinta do Pinheiro, n.º 5 - 2615-184 Alverca do Ribatejo.






    Reason for Withdrawing:

    Updating of the WDA Header regarding a change in the legal address of the Authorisation Holder.







    Union Format for a Wholesale Distribution Authorisation

    A035/14/H/008/2024


    Page 1





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