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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2025-03-14
  • RTF Template


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

    UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

    Human medicinal products


    1. Authorisation Number

    :

    A005/23/H/001/2023

    2. Name of Authorisation Holder

    :

    Seacross (Europe) Unipessoal Lda.

    (ORG-100045917 / LOC-100075727)

    3. Address(es) of Site(s)

    :

    Parque Industrial De Vialonga 24 25 35 E 36, Granja, Vialonga, 2625-607, Portugal 




    4. Legally registered address of Authorisation Holder

    :

    Avenida Principal N 7, Semineira, Milharado, 2665-377

    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

    :

    2023-02-22

    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: Seacross (Europe) Unipessoal Lda.

    (ORG-100045917 / LOC-100077434)

    , Parque Industrial De Vialonga 24 25 35 E 36, Granja, Vialonga, 2625-607, 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

       3.4. Other products: Oncologic medicinal products




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

    Complete Site Address: Parque Empresarial Vialonga - Granja, n.º 24, 25, 35 e 36, Casal do Bagulho, Granja de Alpriate - 2625-607 Vialonga.








    Reason for Withdrawing:

    Updating the Annex 1 of the WDA.








    Union Format for a Wholesale Distribution Authorisation

    A005/23/H/001/2023


    Page 1





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