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RTF Template

Regierung Von Oberbayern

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	DE_BY_04_WDA_2025/ROB-55Ph- 2678.Ph_3-514-19-11
2. Name of Authorisation Holder	:	Regeneron GmbH (ORG-100048605 / LOC-100089435)
3. Address(es) of Site(s)	:	Pettenkoferstrasse 18, Ludwigsvorstadt-Isarvorstadt, Munich, Bavaria, 80336, Germany

4. Legally registered address of Authorisation Holder	:	Pettenkoferstrasse 18, Ludwigsvorstadt-Isarvorstadt, Munich, Bavaria, 80336
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	:	2025-07-07
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: Regeneron GmbH

(ORG-100048605 / LOC-100089435)

, Pettenkoferstrasse 18, Ludwigsvorstadt-Isarvorstadt, Munich, Bavaria, 80336, 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

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

3.2.2. Other temperatures: (please specify) medicines requiring refrigeration

Union Format for a Wholesale Distribution Authorisation	DE_BY_04_WDA_2025/ROB-55Ph- 2678.Ph_3-514-19-11
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