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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_2026_3112-0104/20260205
2. Name of Authorisation Holder	:	Bruns + Klein Dentalfachhandel GmbH
3. Address(es) of Site(s)	:	Im Metternicher Feld 5-7, Metternich, Koblenz, 56072, Germany

4. Legally registered address of Authorisation Holder	:	Im Metternicher Feld 5-7, Koblenz, 56072
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	:	2026-02-05
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: Bruns + Klein Dentalfachhandel GmbH

(ORG-100035064 / LOC-100055605)

, Im Metternicher Feld 5-7, Metternich, Koblenz, 56072, Germany

Human medicinal products

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.3. Other products: (please specify here or make a reference to Annex 5) Medical gases Medizinische Gase

Any restrictions or clarifying remarks (for all users): please refer to the german version.

.
Die Großhandelstätigkeit wird nur als Streckengeschäft mit der GLS Logistik GmbH & Co. Dental Handel KG, Richard-Roosen-Straße 10, 34123 Kassel, ausgeübt.

Zu Ziffer 1.1:
Die Tätigkeit ist beschränkt auf den Großhandel mit:

• Fertigarzneimitteln, die ausschließlich in der Zahnheilkunde verwendet werden und bei der Behandlung am Patienten angewendet werden (§ 47 Abs. 1 Nr. 6 AMG).
Die Lieferung erfolgt ausschließlich an Zahnärzte.

• zum äußeren Gebrauch bestimmte Desinfektionsmittel sowie Mund- und Rachendesinfektionsmittel (§ 44 Abs. 2 Nr. 5 AMG).
Die Lieferung erfolgt ausschließlich an Zahnärzte und Ärzte.

Zu Ziffer 3.3:
Die Lieferung erfolgt ausschließlich an Ärzte.

Union Format for a Wholesale Distribution Authorisation	DE_RP_01_WDA_2026_3112-0104/20260205
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