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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2025-11-10
  • RTF Template


    National Authority Of Medicines And Health Products

    UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

    Human medicinal products


    1. Authorisation Number

    :

    A017/19/H/005/2024

    2. Name of Authorisation Holder

    :

    Ocp Portugal Produtos Farmaceuticos S.A.

    (ORG-100019830 / LOC-100028573)

    3. Address(es) of Site(s)

    :

    Zona Industrial Constantim 224, Vila Real, 5000-082, Portugal 

    Rua Coronel Edgar Pereira Da Costa Cardoso 3e 3a, Vila Franca De Xira, 2615-382, Portugal 

    Zona Industrial De Cotoas, Torres Novas, 2350-484, Portugal 

    Crestins, Rua Do Barreiro 179, Moreira, 4470-573, Portugal 

    Estrada Do Aerodromo 45, Viseu, 3515-342, Portugal 

    Lote 1d Ribeiro Meirinho, Loteamento Industrial Algarpark, Silves, 8375-071, Portugal 




    4. Legally registered address of Authorisation Holder

    :

    Rua Do Barreiro N 235, Crestins - Moreira, 4470-573 MAIA, 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

    :

    2024-10-16

    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: Ocp Portugal Produtos Farmaceuticos S.A.

    (ORG-100019830 / LOC-100090203)

    , Zona Industrial Constantim 224, Vila Real, 5000-082, Portugal   



    Human medicinal products


    1. MEDICINAL PRODUCTS

       1.1. with a Marketing Authorisation or registration 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

       3.1. Narcotic or psychotropic products** 

       3.2. Products requiring low temperature handling 

         3.2.1. Temperatures between 2 to 8 °C 

       3.3. Other products: (please specify here or make a reference to Annex 5) Immunological medicinal products.




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

    Updating of the Annex 1 of the WDA regarding a change in the WDA scope activity.


    Name and address of the site: Ocp Portugal Produtos Farmaceuticos S.A.

    (ORG-100019830 / LOC-100065356)

    , Rua Coronel Edgar Pereira Da Costa Cardoso 3e 3a, Vila Franca De Xira, 2615-382, Portugal   



    Human medicinal products


    1. MEDICINAL PRODUCTS

       1.1. with a Marketing Authorisation or registration 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

       3.1. Narcotic or psychotropic products** 

       3.2. Products requiring low temperature handling 

         3.2.1. Temperatures between 2 to 8 °C 

       3.3. Other products: (please specify here or make a reference to Annex 5) Immunological medicinal products.




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

    Updating the Annex 1 of the WDA regarding a change in the WDA scope activity.


    Name and address of the site: Ocp Portugal Produtos Farmaceuticos S.A.

    (ORG-100019830 / LOC-100065353)

    , Zona Industrial De Cotoas, Torres Novas, 2350-484, Portugal   



    Human medicinal products


    1. MEDICINAL PRODUCTS

       1.1. with a Marketing Authorisation or registration 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

       3.1. Narcotic or psychotropic products** 

       3.2. Products requiring low temperature handling 

         3.2.1. Temperatures between 2 to 8 °C 

       3.3. Other products: (please specify here or make a reference to Annex 5) Immunological medicinal products.




    Any restrictions or clarifying remarks (for all users):  WDA scope activity - Wholesale Distributor and 3 PL (Third Party Logistics Providers).

    Updating the Annex 1 of the WDA regarding a change in the WDA scope activity.


    Name and address of the site: Ocp Portugal Produtos Farmaceuticos S.A.

    (ORG-100019830 / LOC-100038468)

    , Crestins, Rua Do Barreiro 179, Moreira, 4470-573, Portugal   



    Human medicinal products


    1. MEDICINAL PRODUCTS

       1.1. with a Marketing Authorisation or registration 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

       3.1. Narcotic or psychotropic products** 

       3.2. Products requiring low temperature handling 

         3.2.1. Temperatures between 2 to 8 °C 

       3.3. Other products: (please specify here or make a reference to Annex 5) Immunological medicinal products.




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

    Updating the Annex 1 of the WDA regarding a change in the WDA scope activity.

    Complete Site Address: Rua do Barreiro, n.º 179, Fração F, G e H, Crestins-Moreira - 4470-573 Maia.


    Name and address of the site: Ocp - Portugal - Produtos Farmacêuticos S.A.

    (ORG-100019833 / LOC-100065354)

    , Estrada Do Aerodromo 45, Viseu, 3515-342, Portugal   



    Human medicinal products


    1. MEDICINAL PRODUCTS

       1.1. with a Marketing Authorisation or registration 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

       3.1. Narcotic or psychotropic products** 

       3.2. Products requiring low temperature handling 

         3.2.1. Temperatures between 2 to 8 °C 

       3.3. Other products: (please specify here or make a reference to Annex 5) Immunological medicinal products.




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

    Updating the Annex 1 of the WDA regarding a change in the WDA scope activity.


    Name and address of the site: Ocp Portugal Produtos Farmaceuticos S.A.

    (ORG-100019830 / LOC-100063923)

    , Lote 1d Ribeiro Meirinho, Loteamento Industrial Algarpark, Silves, 8375-071, Portugal   



    Human medicinal products


    1. MEDICINAL PRODUCTS

       1.1. with a Marketing Authorisation or registration 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

       3.1. Narcotic or psychotropic products** 

       3.2. Products requiring low temperature handling 

         3.2.1. Temperatures between 2 to 8 °C 

       3.3. Other products: (please specify here or make a reference to Annex 5) Immunological medicinal products.




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

    Updating the Annex 1 of the WDA regarding a change in the WDA scope activity.



    **Without prejudice to further authorisations as may be required according to national legislation.






    Reason for Withdrawing:

    Updating the Annex 1 of the WDA regarding an withdraw of the export activity in this site.








    Union Format for a Wholesale Distribution Authorisation

    A017/19/H/005/2024


    Page 1





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