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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2025-05-14
  • RTF Template


    National Authority Of Medicines And Health Products

    UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

    Human medicinal products


    1. Authorisation Number

    :

    A011/24/H/001/2024

    2. Name of Authorisation Holder

    :

    Canapac Lda.

    (ORG-100050257 / LOC-100087723)

    3. Address(es) of Site(s)

    :

    Rua 3b Lote 48, Zona Industrial De Cantanhede, Cantanhede, 3060-197, Portugal 




    4. Legally registered address of Authorisation Holder

    :

    Rua 3b Lote 48, Zona Industrial De Cantanhede, Cantanhede, 3060-197, 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

    :

    2024-06-19

    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: Canapac Lda.

    (ORG-100050257 / LOC-100087723)

    , Rua 3b Lote 48, Zona Industrial De Cantanhede, Cantanhede, 3060-197, Portugal   



    Human medicinal products


    1. MEDICINAL PRODUCTS

       1.1. with a Marketing Authorisation in EEA country(s)

       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 



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

    Updating of the Annex 5 regarding the inclusion of Substances and preparations based on cannabis
    plant for medicinal purposes approved as finished products.








    Reason for Withdrawing:

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








    Union Format for a Wholesale Distribution Authorisation

    A011/24/H/001/2024


    Page 1





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