Fri 23 Oct 2026 01:05:48 BST
Search Company
*

Active Substance
New Active Substance
Search Site
--
*

Create Site
--
*
*
*
*
*
*
Update Site
Current data stored in EudraGMDP databaseCurrent data stored in OMS
--
Characters remaining:4000/4000
New Active Substance Importation
Active Substance*
Active Substance (English):
Active Substance (NL):
NCA Reference Key:
3rd Country Manufacturer
3rd Country ManufacturerOMS Location IdentifierOMS Organisation IdentifierLegal AddressNCA Reference KeyConfidentialEditDelete
No records found.

3rd Country Distributor
3rd Country DistributorOMS Location IdentifierOMS Organisation IdentifierLegal AddressNCA Reference KeyConfidentialEditDelete
No records found.

Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2025-10-13
  • RTF Template


    Landesamt Fuer Soziale Dienste Schleswig Holstein

    UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

    Human medicinal products


    1. Authorisation Number

    :

    DE_SH_01_WDA_2024_0001 (LOC-10006223)

    2. Name of Authorisation Holder

    :

    Bay Pharma GmbH

    (ORG-100014232 / LOC-100062223)

    3. Address(es) of Site(s)

    :

    Marienthaler Strasse 17, Eckernfoerde, Schleswig-Holstein, 24340, Germany 




    4. Legally registered address of Authorisation Holder

    :

    Marienthaler Strasse 17, Eckernfoerde, Schleswig-Holstein, 24340

    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

    :

    2024-01-12

    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: Bay Pharma GmbH

    (ORG-100014232 / LOC-100062223)

    , Marienthaler Strasse 17, Eckernfoerde, Schleswig-Holstein, 24340, Germany   



    Human medicinal products


    1. MEDICINAL PRODUCTS

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


    2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

       2.1. Procurement 

       2.3. Supply 

       2.4. Export 


    3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

       3.3. Cold chain products(requiring low temperature handling) 




    Any restrictions or clarifying remarks (for all users):  Outsourced activities:

    The pilocarpine hydrochloride tablets are stored on behalf of Hommel Pharma GmbH & Co. KG at the following address: Auf dem Quellberg 8, 48249 Dülmen, Germany.

    ----------------------------------------------------------------------------------------------------Ausgegliederte Tätigkeiten:

    Die Lagerung von Pilocarpinhydrochlorid-Tabletten wird im Auftrag durch die Firma Hommel Pharma GmbH & Co. KG in der Betriebsstätte Auf dem Quellberg 8, 48249 Dülmen, durchgeführt.








    Reason for Withdrawing:

    New WDA








    Union Format for a Wholesale Distribution Authorisation

    DE_SH_01_WDA_2024_0001 (LOC-10006223)


    Page 1





    Loading, please wait