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RTF Template


Regierungsprasidium Karlsruhe

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products


1. Authorisation Number

:

DE_BW_03_WDA_2026_0004

2. Name of Authorisation Holder

:

Becton Dickinson GmbH

(ORG-100034939 / LOC-100055403)

3. Address(es) of Site(s)

:

Tullastraße 8-12, Heidelberg, 69126, Germany 




4. Legally registered address of Authorisation Holder

:

Tullastrasse 8-12, Rohrbach, Heidelberg, 69126

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

:

2026-10-01

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: Becton Dickinson GmbH

, Tullastraße 8-12, Heidelberg, 69126, Germany   



Human medicinal products


1. MEDICINAL PRODUCTS

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


2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

   2.1. Procurement 

   2.3. Supply 

   2.5. Other activities(s): (please specify) holding as an outsourced activity in an external warehouse (see Annex 2)Lagerung in einem beauftragten Betrieb (siehe Anlage 2)



Any restrictions or clarifying remarks (for all users):  ref 1.1 For the product portfolio of Becton Dickinson GmbH only. There is no physical handling of medicinal products on the site.

zu 1.1 Nur für das Produktportfolio der Firma Becton Dickinson GmbH. In der Betriebsstätte erfolgt kein physischer Umgang mit Arzneimitteln.















Union Format for a Wholesale Distribution Authorisation

DE_BW_03_WDA_2026_0004


Page 1





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