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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_2026/ ROB-55Ph-2678.Ph_3-349-31-10
2. Name of Authorisation Holder	:	Kedrion Biopharma GmbH (ORG-100017217 / LOC-100026008)
3. Address(es) of Site(s)	:	Bahnhofstrasse 96, Graefelfing, Bavaria, 82166, Germany

4. Legally registered address of Authorisation Holder	:	Bahnhofstrasse 96, Graefelfing, Bavaria, 82166
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	:	2026-07-27
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: Kedrion Biopharma GmbH

(ORG-100017217 / LOC-100026008)

, Bahnhofstrasse 96, Graefelfing, Bavaria, 82166, 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

3.3. Other products: (please specify here or make a reference to Annex 5) Medicinal products derived from blood, immunological medicinal products

Any restrictions or clarifying remarks (for all users): Re 2.2: External storage provided by a storage service provider (see Annex 2)

zu 2.2: externe Lagerung durch Lagerdienstleister (s. Anlage 2)

Union Format for a Wholesale Distribution Authorisation	DE_BY_04_WDA_2026/ ROB-55Ph-2678.Ph_3-349-31-10
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