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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2025-04-02
    		•
    RTF Template


    National Authority Of Medicines And Health Products

    UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

    Human medicinal products


    1. Authorisation Number

    :

    A019/20/H/003/2023

    2. Name of Authorisation Holder

    :

    Servier Portugal Especialidades Farmaceuticas Lda.

    (ORG-100003511 / LOC-100077111)

    3. Address(es) of Site(s)

    :

    Eira Park Armazem B4, Lugar Do Penedo De Talaide, Rio De Mouro, 2635-631, Portugal 

    Estrada Nacional 9 Km 17, Fervenca, Terrugem Snt, 2709-504, Portugal 




    4. Legally registered address of Authorisation Holder

    :

    Torre Oriente Avenida Colegio Militar 37f, Fracoes B Piso 6, Lisbon, 1500-180

    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

    :

    2023-07-12

    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: Servier Portugal Especialidades Farmaceuticas Lda.

    (ORG-100003511 / LOC-100065287)

    , Eira Park Armazem B4, Lugar Do Penedo De Talaide, Rio De Mouro, 2635-631, 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 


    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.

    Complete Legal Address: Torre Oriente, Avenida Colégio Militar, n.º 37 F, Piso 6, Frações B e C - 1500-180 Lisboa.

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


    Name and address of the site: Servier Portugal Especialidades Farmaceuticas Lda.

    (ORG-100003511 / LOC-100069989)

    , Estrada Nacional 9 Km 17, Fervenca, Terrugem Snt, 2709-504, 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 


    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.

    Complete Legal Address: Torre Oriente, Avenida Colégio Militar, n.º 37 F, Piso 6, Frações B e C - 1500-180 Lisboa.

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






    Reason for Withdrawing:

    Updating WDA by removing one of the sites (based on the cessation of distribution activity on that
    site).







    Union Format for a Wholesale Distribution Authorisation

    A019/20/H/003/2023


    Page 1





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