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RTF Template

Hessian Office For Health And Care

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	DE_HE_01_WDA_2026_0020
2. Name of Authorisation Holder	:	Biotest GmbH & Co. KGaA (ORG-100006306 / LOC-100010709)
3. Address(es) of Site(s)	:	Landsteinerstrasse 6, Dreieichenhain, Dreieich, Hesse, 63303, Germany Daimlerstrasse 1, Dreieichenhain, Dreieich, Hesse, 63303, Germany Siemensstrasse 11, Dreieichenhain, Dreieich, Hesse, 63303, Germany

4. Legally registered address of Authorisation Holder	:	Landsteinerstrasse 5, Dreieichenhain, Dreieich, 63303
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	:	2026-06-15
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: Biotest GmbH & Co. KGaA

(ORG-100006306 / LOC-100103109)

, Landsteinerstrasse 6, Dreieichenhain, Dreieich, Hesse, 63303, Germany

Human medicinal products

1. MEDICINAL PRODUCTS

1.1. with a Marketing Authorisation or registration in EEA country(s)

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.2. Holding

2.5. Other activities(s): (please specify) Storage by a contracted storage company (see Annex 5)Lagerung durch einen beauftragten Lagerbetrieb (siehe Anlage 5)

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.3. Other products: (please specify here or make a reference to Annex 5) 3.1.2 Medicinal products derived from blood 3.3 Cold chain products (requiring low temperature handling)

Name and address of the site: Biotest GmbH & Co. KGaA

(ORG-100006306 / LOC-100062992)

, Daimlerstrasse 1, Dreieichenhain, Dreieich, Hesse, 63303, 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

2.4. Export

2.5. Other activities(s): (please specify) Storage by a contracted storage company (see Annex 5)Lagerung durch einen beauftragten Lagerbetrieb (siehe Anlage 5)

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)

Name and address of the site: Biotest GmbH & Co. KGaA

(ORG-100006306 / LOC-100062993)

, Siemensstrasse 11, Dreieichenhain, Dreieich, Hesse, 63303, Germany

Human medicinal products

1. MEDICINAL PRODUCTS

1.1. with a Marketing Authorisation or registration in EEA country(s)

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.2. Holding

2.3. Supply

2.4. Export

2.5. Other activities(s): (please specify) Storage by a contracted storage company (see Annex 5)Lagerung durch einen beauftragten Lagerbetrieb (siehe Anlage 5)

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)

Union Format for a Wholesale Distribution Authorisation	DE_HE_01_WDA_2026_0020
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