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RTF Template

Regierungspraesidium Tuebingen Pharmazeutische Angelegenheiten

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	DE_BW_05_WDA_2024_0002
2. Name of Authorisation Holder	:	Laborbedarf Klobasa GmbH & Co.KG (ORG-100050992 / LOC-100089206)
3. Address(es) of Site(s)	:	Hermann-Koehl-Weg 5, Boefingen, Ulm, Baden-Wuerttemberg, 89075, Germany

4. Legally registered address of Authorisation Holder	:	Hermann-Koehl-Weg 5, Boefingen, Ulm, Baden-Wuerttemberg, 89075
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	:	2024-03-12
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: Laborbedarf Klobasa GmbH & Co.KG

(ORG-100050992 / LOC-100089206)

, Hermann-Koehl-Weg 5, Boefingen, Ulm, Baden-Wuerttemberg, 89075, Germany

Human medicinal products

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.3. Supply

Any restrictions or clarifying remarks (for all users): Ref 1.1: The range of medicinal products comprises only availaible in pharmacies injection and infusion solutions as well as solvents for the preparation/reconstitution (acc. section 4 subsection 31 Medicinal Products Act [AMG]) of medicinal products.
Ref. 2.1 and 2.3: Supply only by drop shipment.
This WDA is based on floor plans sent on 18th January 2024 and comprises the room "Buero" (dated on 28/12/2004).

Zu 1.1: Das Sortiment umfasst apothekenpflichtige Injektions- und Infusionslösungen sowie Lösungsmittel zur Herstellung/Rekonstitution von Arzneimitteln.
Zu 2.1 und 2.3: Handel erfolgt ausschließlich im Streckengeschäft (Handel ohne Lagerung).
Die Erlaubnis basiert auf dem am 18.01.2024 übersandten Grundrissplan und umfasst den Raum „Büro" (Stand: 28.12.2004).

Union Format for a Wholesale Distribution Authorisation	DE_BW_05_WDA_2024_0002
	Page 1

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