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RTF Template

Regierungsprasidium Karlsruhe

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	DE_BW_03_WDA_2024_0005
2. Name of Authorisation Holder	:	Staehle & Co. GmbH (ORG-100052370 / LOC-100092218)
3. Address(es) of Site(s)	:	Bleichstrasse 4, Suedweststadt, Pforzheim, Baden-Wuerttemberg, 75173, Germany

4. Legally registered address of Authorisation Holder	:	Bleichstrasse 4, Suedweststadt, Pforzheim, Baden-Wuerttemberg, 75173, Germany
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
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2024-07-23
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: Staehle & Co. GmbH

(ORG-100052370 / LOC-100092218)

, Bleichstrasse 4, Suedweststadt, Pforzheim, Baden-Wuerttemberg, 75173, 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

Any restrictions or clarifying remarks (for all users): Only includes the trade in skin and hand disinfectants and infusion solutions in accordance with Sect. 47 para 1 AMG (German Medicinal Products Act). Supply of medicinal products by the distribution center Co-med GmbH & Co. KG, 66265 Heusweiler, Germany.

Umfasst ausschließlich den Handel mit Haut- und Händedesinfektionsmitteln und Infusionslösungen nach § 47 Abs. 1 AMG. Auslieferung der Arzneimittel erfolgt über das Versandlager Co-med GmbH & Co. KG, 66265 Heusweiler, Deutschland.

*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_03_WDA_2024_0005
	Page 1

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