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RTF Template

Landesamt Fuer Soziales Jugend Und Versorgung

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	DE_RP_01_WDA_2025/3112-0189/251001
2. Name of Authorisation Holder	:	Novo Nordisk Pharma GmbH (ORG-100002710 / LOC-100081623)
3. Address(es) of Site(s)	:	Isaac-Fulda-Allee 24, Gonsenheim, Mainz, 55124, Germany

4. Legally registered address of Authorisation Holder	:	Isaac-Fulda-Allee 24, Gonsenheim, Mainz, 55124
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	:	2025-10-01
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: Novo Nordisk Pharma GmbH

(ORG-100002710 / LOC-100081623)

, Isaac-Fulda-Allee 24, Gonsenheim, Mainz, 55124, 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

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.3. Other products: (please specify here or make a reference to Annex 5) Medicines for the therapy areas diabetes, obesity, blood clotting disorders, growth disorders and p Arzneimittel für die Therapiebereiche Diabetes, Adipositas, Blutgerinnungs- u. Wachstumsstörungen,

Any restrictions or clarifying remarks (for all users): Storage, distribution and order processing are performed by PharmLog Pharma Logistik GmbH, Siemensstrasse 1 and Edisonstrasse 25, D-59199 Boenen. Customer service is provided by Vilua Vitartis Service GmbH, Gützkower Landstr. 36-40, 17489 Greifswald and for archiving Iron Mountain GmbH - Location Butzbach, Magnapark Unit 1, Kirchgoens, D-35510 Butzbach, was commissioned.

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Lagerung, Distribution und Auftragsbearbeitung erfolgen über die Firma PharmLog Pharma Logistik GmbH, Siemensstraße 1 und Edisonstraße 25, 59199 Bönen. Der Kundenservice erfolgt durch die Firma Vilua Vitartis Service GmbH, Gützkower Landstr. 36-40, 17489 Greifswald und für die Archivierung wurde die Firma Iron Mountain GmbH - Standort Butzbach, Magnapark Unit 1, Kirchgöns, 35510 Butzbach, beauftragt.

Union Format for a Wholesale Distribution Authorisation	DE_RP_01_WDA_2025/3112-0189/251001
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