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RTF Template

Regierungspraesidium Tuebingen Leitstelle Arzneimittelueberwachung Baden-Wuerttemberg

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products and Veterinary medicinal products

1. Authorisation Number	:	DE_BW_01_WDA_2023_0001_Health Logistics
2. Name of Authorisation Holder	:	Health Logistics GmbH (ORG-100012025 / LOC-100022430)
3. Address(es) of Site(s)	:	Vichystrasse 14, Bruchsal, Baden-Wuerttemberg, 76646, Germany Werner-Von-Siemens-Strasse 2-6, Bruchsal, Baden-Wuerttemberg, 76646, Germany

4. Legally registered address of Authorisation Holder	:	Vichystrasse 14, Bruchsal, Baden-Wuerttemberg, 76646
5. Scope of authorisation (complete for each site under 4)	:	ANNEX 1
6. Legal basis of authorisation	:	Art. 77(1) of Directive 2001/83/EC Art. 99 of Regulation (EU) 2019/6
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2023-05-16
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: Health Logistics GmbH

(ORG-100012025 / LOC-100022430)

, Vichystrasse 14, Bruchsal, Baden-Wuerttemberg, 76646, Germany

Human medicinal products

Veterinary medicinal products

1. MEDICINAL PRODUCTS

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

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

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.1. Narcotic or psychotropic products

3.1.2. Medicinal products derived from blood

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): The authorisation is based on facility layouts submitted on 15.05.2023.

Die Erlaubnis basiert auf den Grundrissplänen übersandt am 15.05.2023.

Name and address of the site: Health Logistics GmbH

(ORG-100012025 / LOC-100079400)

, Werner-Von-Siemens-Strasse 2-6, Bruchsal, Baden-Wuerttemberg, 76646, Germany

Human medicinal products

Veterinary medicinal products

1. MEDICINAL PRODUCTS

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

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

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.1. Narcotic or psychotropic products

3.1.2. Medicinal products derived from blood

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): The authorisation is based on facility layouts submitted on 15.05.2023.
Office activities only at this site.

Die Erlaubnis basiert auf den Grundrissplänen übersandt am 15.05.2023.
An diesem Standort werden nur Bürotätigkeiten durchgeführt.

*Art 5 of Directive 2001/83/EC or Art 83 of Regulation EC/726/2004

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

Union Format for a Wholesale Distribution Authorisation	DE_BW_01_WDA_2023_0001_Health Logistics
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