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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2024-12-11
    		•
    RTF Template


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

    UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION


    1. Authorisation Number

    :

    A022/10/H/002/2018

    2. Name of Authorisation Holder

    :

    Propecuária - Veterinária e Farmacêutica, Lda.

    3. Address(es) of Site(s)

    :

    Rua Principal, Lote 12/15 C, Zona Industrial de Porto de Mós, Leiria, 2480-407 Porto de Mós, Portugal 




    4. Legally registered address of Authorisation Holder

    :

    Rua Principal, Lote 12/16 C, Zona Industrial de Porto de Mós, Leiria, 2480-407 Porto de Mós, 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

    :

    2018-11-08

    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: Propecuária - Veterinária e Farmacêutica, Lda.

    , Rua Principal, Lote 12/15 C, Zona Industrial de Porto de Mós, Leiria, 2480-407 Porto de Mós, 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

         3.1.1. Narcotic or psychotropic products 

         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 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.

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

    Updating of the Authorised Site, regarding a Toponymy change in the Address of the Site.

    The Authorisation number A022/10/H/002/2018 replaces the previous one with the Authorisation number A022/10/H/001/2018, of 2018-04-23






    Reason for Withdrawing:

    Updating of the WDA Header regarding a change in the legal name of the Authorisation Holder and a
    toponymy change in the legal address of the Authorisation Holder and in the Address of the Site.







    Union Format for a Wholesale Distribution Authorisation

    A022/10/H/002/2018


    Page 1





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