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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 – Biotrade GmbH/02
2. Name of Authorisation Holder	:	Biotrade GmbH (ORG-100047356 / LOC-100078225)
3. Address(es) of Site(s)	:	Doebelner Strasse 5, Hellersdorf, Berlin, 12627, Germany

4. Legally registered address of Authorisation Holder	:	Doebelner Strasse 5, Hellersdorf, Berlin, 12627
5. Scope of authorisation	:	ANNEX 1
6. Legal basis of authorisation	:	Sect 52a para 1 des Gesetzes über den Verkehr mit Arzneimitteln - Arzneimittelgesetz (German Drug Law)
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2025-11-19
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: Biotrade GmbH

(ORG-100047356 / LOC-100078225)

, Doebelner Strasse 5, Hellersdorf, Berlin, 12627, 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

2.2. Holding

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

3.3. Other products: (please specify here or make a reference to Annex 5) blood products: only immuno-globulin

Any restrictions or clarifying remarks (for all users): The authorisation is based on floor plan 1 and 2 from 2025-7-15 (only yellow-labelled areas).

Die Erlaubnis beruht auf dem Grundrissplänen 1 und 2 vom 15.07.2025 und bezieht sich auf die gelb gekennzeichneten Bereiche.

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