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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2024-12-30
  • RTF Template


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

    UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION


    1. Authorisation Number

    :

    A007/21/H/001/2021

    2. Name of Authorisation Holder

    :

    Dplus, Sociedade Unipessoal, Lda.

    3. Address(es) of Site(s)

    :

    Parque Empresarial da Granja-Vialonga, n.º 17, 18, 19 e 20, Casal do Bagulho - Granja de Alpriate, Vila Franca de Xira, 2625-607 Vialonga, Portugal 




    4. Legally registered address of Authorisation Holder

    :

    Parque Empresarial da Granja, Armazém 18, Casal do Bagulho - Granja de Alpriate, Vila Franca de Xira, 2625-607 Vialonga, Portugal

    5. Scope of authorisation

    :

    ANNEX 1

    6. Legal basis of authorisation

    :


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

    :

    Confidential, Confidential

    8. Signature

    :


    9. Date

    :

    2021-03-02

    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: Dplus, Sociedade Unipessoal, Lda.

    , Parque Empresarial da Granja-Vialonga, n.º 17, 18, 19 e 20, Casal do Bagulho - Granja de Alpriate, Vila Franca de Xira, 2625-607 Vialonga, Portugal   




    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 

         3.1.4. Radiopharmaceuticals (including radionuclide kits) 

       3.3. Cold chain products(requiring low temperature handling) 

       3.4. Other products: Cytotoxic, Herbal and Homeopathic medicinal products.




    Any restrictions or clarifying remarks (for all users):  National legal basis of authorisation: Art. 94.º of Decree-law 176/2006, of 30th August.

    WDA scope activity - Wholesale Distributor.








    Reason for Withdrawing:

    Updating of the Annex 1 on the WDA regarding the inclusion of the reference to narcotic or
    psychotropic products.








    Union Format for a Wholesale Distribution Authorisation

    A007/21/H/001/2021


    Page 1





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