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RTF Template

Landesamt Fuer Gesundheit Und Soziales

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	DE_BE_01_WDA_2025_5373/1 – Bioprojet Deutschland GmbH/02
2. Name of Authorisation Holder	:	Bioprojet Deutschland GmbH (ORG-100035026 / LOC-100055541)
3. Address(es) of Site(s)	:	Bismarckstrasse 63, Steglitz, Berlin, 12169, Germany

4. Legally registered address of Authorisation Holder	:	Bismarckstrasse 63, Steglitz, Berlin, 12169
5. Scope of authorisation	:	ANNEX 1
6. Legal basis of authorisation	:	Art. 77(1) of Directive 2001/83/EC § 52a (1) Arzneimittelgesetz AMG (German Medicinal Products Act)
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2025-04-04
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: Bioprojet Deutschland GmbH

(ORG-100035026 / LOC-100055541)

, Bismarckstrasse 63, Steglitz, Berlin, 12169, 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) External storage in a contracted company.Externe Lagerung in einem beauftragten Betrieb.

Any restrictions or clarifying remarks (for all users): This authorisation is based on the floor plan dated 2024-11-07.
There is no physical handling of medicinal products at the site.

Diese Erlaubnis basiert auf dem Grundrissplan vom 07.11.2024.
In der Betriebsstätte erfolgt kein physischer Umgang mit Arzneimitteln.

Union Format for a Wholesale Distribution Authorisation	DE_BE_01_WDA_2025_5373/1 – Bioprojet Deutschland GmbH/02
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