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RTF Template


Trade and Industry Inspection Agency of State of Lower Saxony – Oldenburg

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION


1. Authorisation Number

:

DE_NI_04_WDA_2021_0007 / 41403-16/32

2. Name of Authorisation Holder

:

B. Braun Gesundheitsserivce GmbH

3. Address(es) of Site(s)

:

Gewerbepark Ebbendorf 14, Hilter, Niedersachsen, 49176, Germany 




4. Legally registered address of Authorisation Holder

:

Gewerbepark Ebbendorf 14, Hilter, Niedersachsen, 49176, Germany

5. Scope of authorisation (complete for each site under 4)

:

ANNEX 1

6. Legal basis of authorisation

:


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

:

Confidential, Confidential

8. Signature

:


9. Date

:

2021-07-14

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: B. Braun Gesundheitsservice GmbH

, Gewerbepark Ebbendorf 14, Hilter, Niedersachsen, 49176, Germany   




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 



Any restrictions or clarifying remarks (for all users):  Parenteral nutrition
Skin- and Hand Disinfectant
Infusion solutions

To Annex5:  Name and address of the external warehouse in the subcontract:
Heinrich Koch International Spedition GmbH & Co. KG
Am Tie 11, 49086 Osnabrück

Parenterale Ernährung
Haut- und Hände Desinfektionsmittel
Infusionslösungen

Anlage 5: Name und Anschrift des Externen Lagers im Lohnauftrag :

Heinrich Koch Internationale Spedition GmbH & Co. KG
Am Tie 11, 49086 Osnabrück



*Art 5 of Directive 2001/83/EC or Art 83 of Regulation EC/726/2004

**Without prejudice to further authorisations as may be required according to national legislation













Union Format for a Wholesale Distribution Authorisation

DE_NI_04_WDA_2021_0007 / 41403-16/32


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