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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_2025/3112-0159/20250520
2. Name of Authorisation Holder	:	Boehringer Ingelheim Pharma GmbH & Co. KG (ORG-100000199 / LOC-100004370)
3. Address(es) of Site(s)	:	Binger Strasse 173, Ingelheim Am Rhein, 55216, Germany

4. Legally registered address of Authorisation Holder	:	Binger Strasse 173, Ingelheim Am Rhein, 55216
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	:	2025-05-20
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: Boehringer Ingelheim Pharma GmbH & Co. KG

(ORG-100000199 / LOC-100004370)

, Binger Strasse 173, Ingelheim Am Rhein, 55216, Germany

Human medicinal products

1. MEDICINAL PRODUCTS

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

1.3. without a Marketing Authorisation or registration in the EEA and intended for exportation

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

Any restrictions or clarifying remarks (for all users): Contracted company for storage and distribution:
PharmLog Pharma Logistik GmbH, Siemensstrasse 1, 59199 Bönen with the operating facilities Siemensstrasse 1, 59199 Bönen and Edisonstrasse 25, 59199 Bönen.
The competent authority is aware of the current product list, dated February 07, 2025.

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Beauftragtes Unternehmen für Lagerung und Vertrieb:
PharmLog Pharma Logistik GmbH, Siemensstrasse 1, 59199 Bönen mit den Betriebsstätten Siemensstrasse 1, 59199 Bönen und Edisonstrasse 25, 59199 Bönen.
Die aktuelle Produktliste (Stand:07.02.2025) ist der zuständigen Behörde bekannt.

Union Format for a Wholesale Distribution Authorisation	DE_RP_01_WDA_2025/3112-0159/20250520
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