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RTF Template

Landesamt Fuer Soziales Jugend Und Versorgung

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	DE_RP_01_WDA_2025/3112-0149/20250701
2. Name of Authorisation Holder	:	Alliance Healthcare Deutschland GmbH (ORG-100015186 / LOC-100097534)
3. Address(es) of Site(s)	:	Am Herrschaftsweiher 1, Ruchheim, Ludwigshafen Am Rhein, Rhineland-Palatinate, 67071, Germany Denisstrasse 32, Innenstadt, Kaiserslautern, Rhineland-Palatinate, 67663, Germany

4. Legally registered address of Authorisation Holder	:	Franklinstrasse 46-48, Bockenheim, Frankfurt Am Main, Hesse, 60486
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	:	2025-07-01
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: Alliance Healthcare Deutschland GmbH

(ORG-100015186 / LOC-100062575)

, Am Herrschaftsweiher 1, Ruchheim, Ludwigshafen Am Rhein, Rhineland-Palatinate, 67071, Germany

Human medicinal products

1. MEDICINAL PRODUCTS

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

1.2. without a Marketing Authorisation or registration in the EEA and intended for EEA market*

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

2.5. Other activities(s): (please specify) Drop Shipment/Streckengeschäft

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1. Narcotic or psychotropic products**

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) see remarks siehe Anmerkungen

Any restrictions or clarifying remarks (for all users): to 3.3: Medicinal products derived from blood; Immunological Medicinal products; Medicinal gases (in small cylinder format)

-------------------------------------------------------------------------------------------------------------
zu 3.3: Arzneimittel aus Blut; immunologische Arzneimittel; Medizinische Gase (im Kleinflaschenformat)

Name and address of the site: Alliance Healthcare Deutschland GmbH

(ORG-100015186 / LOC-100054778)

, Denisstrasse 32, Innenstadt, Kaiserslautern, Rhineland-Palatinate, 67663, Germany

Human medicinal products

1. MEDICINAL PRODUCTS

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

1.2. without a Marketing Authorisation or registration in the EEA and intended for EEA market*

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1. Narcotic or psychotropic products**

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) see remarks siehe Anmerkungen

Any restrictions or clarifying remarks (for all users): to 3.3: Medicinal products derived from blood; Immunological Medicinal products; Medicinal gases (in small cylinder format)

----------------------------------------------------------------------------------------------------------
zu 3.3: Arzneimittel aus Blut; immunologische Arzneimittel; Medizinische Gase (im Kleinflaschenformat)

*Art. 5 of Directive 2001/83/EC, Art. 83 of Regulation (EC) 726/2004 and Art. 110 of Regulation 2019/6.

**Without prejudice to further authorisations as may be required according to national legislation.

Union Format for a Wholesale Distribution Authorisation	DE_RP_01_WDA_2025/3112-0149/20250701
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