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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2025-05-29
  • RTF Template


    National Authority of Medicines and Health Products, I.P.

    UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

    Human medicinal products


    1. Authorisation Number

    :

    A075/14/H/004/2022

    2. Name of Authorisation Holder

    :

    Gide Farma Produtos Farmaceuticos Lda.

    (ORG-100002350 / LOC-100001291)

    3. Address(es) of Site(s)

    :

    Rua Dos Tractores N 647, Jardia, Alto Estanqueiro-Jardia, 2870-607, Portugal 




    4. Legally registered address of Authorisation Holder

    :

    Estrada Do Casal Do Canas 6, Carnaxide, 2790-007

    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

    :

    2022-02-07

    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: Gide Farma Produtos Farmaceuticos Lda.

    (ORG-100002350 / LOC-100065079)

    , Rua Dos Tractores N 647, Jardia, Alto Estanqueiro-Jardia, 2870-607, Portugal   



    Human medicinal products


    1. MEDICINAL PRODUCTS

       1.1. with a Marketing Authorisation in EEA country(s)


    2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

       2.1. Procurement 

       2.2. Holding 

       2.3. Supply 

       2.4. Export 


    3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

       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 Authorised Site, regarding a toponymy change in the Address of the Site.

    Complete Site Address: Rua dos Tractores, n.º 647, Terminal 1 e 4, Alto do Estanqueiro-Jardia - 2870-607 Montijo.








    Reason for Withdrawing:

    Updating WDA, regarding a a renewal of the latest Inspection Date of the Certificate of GDP Compliance.








    Union Format for a Wholesale Distribution Authorisation

    A075/14/H/004/2022


    Page 1





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