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RTF Template

Regierung Von Oberfranken

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	DE_BY_05_WDA_2026_ROF-SG55.2-2675.3-125-3-3
2. Name of Authorisation Holder	:	Blutspendedienst des Bayerischen Roten Kreuzes gGmbH (ORG-100023581 / LOC-100103681)
3. Address(es) of Site(s)	:	Heimerichstrasse 57, St. Johannis, Nuremberg, Bavaria, 90419, Germany

4. Legally registered address of Authorisation Holder	:	Kistlerhofstrasse 140, Thalkirchen-Obersendling, Munich, 81379
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	:	2026-07-01
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: Blutspendedienst des Bayerischen Roten Kreuzes gGmbH

(ORG-100023581 / LOC-100032730)

, Heimerichstrasse 57, St. Johannis, Nuremberg, Bavaria, 90419, 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

2.2. Holding

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.3. Other products: (please specify here or make a reference to Annex 5) Medicinal products derived from blood, Cold chain products (requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): Only medicinal products from blood, test sera and test Antigens.

Nur Arzneimittel aus Blut, Testsera und Testantigene.

Union Format for a Wholesale Distribution Authorisation	DE_BY_05_WDA_2026_ROF-SG55.2-2675.3-125-3-3
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