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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_2024/ROB-55Ph- 2678.Ph_2-15-53-4
2. Name of Authorisation Holder	:	Biogen GmbH (ORG-100001588 / LOC-100028013)
3. Address(es) of Site(s)	:	Riedenburger Strasse 7, Bogenhausen, Munich, Bavaria, 81677

4. Legally registered address of Authorisation Holder	:	Riedenburger Strasse 7, Bogenhausen, Munich, Bavaria, 81677
5. Scope of authorisation (complete for each site under 4)	:	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 wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2024-01-31
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: Biogen GmbH

(ORG-100001588 / LOC-100028013)

, Riedenburger Strasse 7, Bogenhausen, Munich, Bavaria, 81677

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

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

3.4. Other products: Medicinal products requiring refrigeration

Any restrictions or clarifying remarks (for all users): 2.1/2.3: Picking, customer qualification and transportation are carried out by the external service provider Arvato SE (see Appendix 2)

zu 2.1/2.3: Kommissionierung, Kundenqualifizierung und Transport erfolgen durch die externe
Dienstleisterin Arvato SE (s. Anlage 2)

*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_BY_04_WDA_2024/ROB-55Ph- 2678.Ph_2-15-53-4
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