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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2025-02-12
    		•
    RTF Template


    Ministerie van Volksgezondheid Welzijn en Sport

    UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

    Human medicinal products


    1. Authorisation Number

    :

    4767 G

    2. Name of Authorisation Holder

    :

    Mosadex C.V.

    (ORG-100018009 / LOC-100026795)

    3. Address(es) of Site(s)

    :

    De Grift 3, Nieuwleusen, 7711 EP, Netherlands 

    Nieuwenhuizenweg 19, Leiden, 2314 XP, Netherlands 

    Business Park Stein 192, Elsloo Lb, 6181 MA, Netherlands 




    4. Legally registered address of Authorisation Holder

    :

    Business Park Stein 192, Elsloo Lb, 6181 MA, Netherlands

    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

    :

    2024-10-24

    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: Mosadex C.V.

    (ORG-100018009 / LOC-100036295)

    , De Grift 3, Nieuwleusen, 7711 EP, Netherlands   



    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

         3.1.2. Medicinal products derived from blood 

         3.1.3. Immunological medicinal products 

       3.3. Cold chain products(requiring low temperature handling) 




    Name and address of the site: Mosadex C.V.

    (ORG-100018009 / LOC-100067013)

    , Nieuwenhuizenweg 19, Leiden, 2314 XP, Netherlands   



    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

         3.1.1. Narcotic or psychotropic products 

         3.1.2. Medicinal products derived from blood 

         3.1.3. Immunological medicinal products 

       3.3. Cold chain products(requiring low temperature handling) 




    Name and address of the site: Mosadex C.V.

    (ORG-100018009 / LOC-100026795)

    , Business Park Stein 192, Elsloo Lb, 6181 MA, Netherlands   



    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

         3.1.1. Narcotic or psychotropic products 

         3.1.2. Medicinal products derived from blood 

         3.1.3. Immunological medicinal products 

       3.3. Cold chain products(requiring low temperature handling) 










    Reason for Withdrawing:

    withdrawn per 1 januari 2025

    ingetrokken per 1 januari 2025







    Union Format for a Wholesale Distribution Authorisation

    4767 G


    Page 1





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