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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_2023_5373/1 - Kade/02
2. Name of Authorisation Holder	:	DR. KADE Pharmazeutische Fabrik GmbH (ORG-100002034 / LOC-100003522)
3. Address(es) of Site(s)	:	Rigistrasse 2, Marienfelde, Berlin, 12277, Germany Mariendorfer Damm 3, Tempelhof, Berlin, 12099, Germany

4. Legally registered address of Authorisation Holder	:	Rigistrasse 2, Marienfelde, Berlin, 12277
5. Scope of authorisation (complete for each site under 4)	:	ANNEX 1
6. Legal basis of authorisation	:	§ 52a (1) Arzneimittelgesetz - AMG (Medicinal Products Act)
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2023-07-21
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: DR. KADE Pharmazeutische Fabrik GmbH

(ORG-100002034 / LOC-100003522)

, Rigistrasse 2, Marienfelde, Berlin, 12277, 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

2.5. Other activities(s): external storage in a contracted companyexterne Lagerung in einem beauftragten Betrieb

Any restrictions or clarifying remarks (for all users): The authorisation is based on the floor plans 1 and 2 from 5th of June 2023.

Die Erlaubnis beruht auf den Grundrissplänen 1 und 2 vom 5. Juni 2023.

Name and address of the site: DR. KADE Pharmazeutische Fabrik GmbH

(ORG-100002034 / LOC-100080134)

, Mariendorfer Damm 3, Tempelhof, Berlin, 12099, 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

2.5. Other activities(s): external storage in a contracted companyexterne Lagerung in einem beauftragten Betrieb

Any restrictions or clarifying remarks (for all users): The authorisation is based on the floor plans 1 and 2 from 5th of June 2023.

Die Erlaubnis basiert auf den Grundrissplänen vom 5. Juni 2023.

*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_BE_01_WDA_2023_5373/1 - Kade/02
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