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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2024-12-24
    		•
    RTF Template


    Ministerie van Volksgezondheid, Welzijn en Sport - Farmatec | CIBG - Cluster Beschikkingen

    UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

    Human medicinal products


    1. Authorisation Number

    :

    6840 G

    2. Name of Authorisation Holder

    :

    Specific Pharma A/S

    (ORG-100036241 / LOC-100057319)

    3. Address(es) of Site(s)

    :

    Victorialaan 15, 'S-HERTOGENBOSCH, 5213JG 




    4. Legally registered address of Authorisation Holder

    :

    Victorialaan 15, S Hertogenbosch, 5213 JG

    5. Scope of authorisation

    :

    ANNEX 1

    6. Legal basis of authorisation

    :

    Art. 77(1) of Directive 2001/83/EC

    7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation

    :

    Confidential, Confidential

    8. Signature

    :


    9. Date

    :

    2022-12-06

    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: Specific Pharma A/S

    (ORG-100036241 / LOC-100057319)

    , Victorialaan 15, 'S-HERTOGENBOSCH, 5213JG   



    Human medicinal products


    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

    2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

       2.1. Procurement 

       2.3. Supply 


    3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

         3.1.3. Immunological medicinal products 

       3.3. Cold chain products(requiring low temperature handling) 










    Reason for Withdrawing:

    withdrawn per 24-12-2024

    ingetrokken per 24-12-2024







    Union Format for a Wholesale Distribution Authorisation

    6840 G


    Page 1





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