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RTF Template

Regierungsprasidium Tubingen - Referat 26: Ubrige Pharmazeutische Bereiche

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	DE_BW_05_WDA_2022_0003
2. Name of Authorisation Holder	:	dental bauer GmbH & Co. KG
3. Address(es) of Site(s)	:	Curiestrasse 4, Vaihingen, Stuttgart, Baden-Wuerttemberg, 70563, Germany Ernst-Simon-Strasse 12, Derendingen, Tuebingen, Baden-Wuerttemberg, 72072, Germany Jechtinger Strasse 10, St. Georgen, Freiburg Im Breisgau, Baden-Wuerttemberg, 79111, Germany

4. Legally registered address of Authorisation Holder	:	Ernst-Simon-Straße 12, Tübingen, 72072
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	:	2022-07-13
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: Dental Bauer GmbH & Co. KG

(ORG-100034543 / LOC-100064206)

, Curiestrasse 4, Vaihingen, Stuttgart, Baden-Wuerttemberg, 70563, 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

2.5. Other activities(s): drop shipmentStreckengeschäfte

Any restrictions or clarifying remarks (for all users): Ref 1.1: finished mecinal products used execlusively in the field of dentistry (section 47 subsection 1 number 7 Medicinal Products Act (AMG)) and hand- and skindisinfectants

Ref 2.1: procurement exclusively by Dental-Union GmbH, Gutenbergring 5, 7-9, 63110 Rodgau. Any physical handling of medicinal products is not allowed.

Ref 2.3: supply only by Dental-Union GmbH, Gutenbergring 7-9, 63110 Rodgau and exclusively to persons authorized to practice dentistry.

Ref 2.5: supply only by drop shipment

Zu 1.1: Handel mit Fertigarzneimitteln ausschließlich zur Zahnheilkunde (§ 47 Abs. 1 Nr. 7 Arzneimittelgesetz) und Haut- und Händedesinfektionsmitteln

Zu 2.1: Beschaffung ausschließlich durch Dental-Union GmbH, Gutenbergring 7-9, 63110 Rodgau. Der körperliche Umgang mit Arzneimitteln ist nicht erlaubt.

Zu 2.3: Lieferung (Abgabe) durch Dental-Union GmbH, Gutenbergring 5, 7-9, 63110 Rodgau und ausschließlich an zur Ausübung der Zahnheilkunde berechtigte Personen.

Zu 2.5: Handel erfolgt (teilweise) im Streckengeschäft (Handel ohne Lagerung)

Name and address of the site: Dental Bauer GmbH & Co. KG

(ORG-100034543 / LOC-100054788)

, Ernst-Simon-Strasse 12, Derendingen, Tuebingen, Baden-Wuerttemberg, 72072, 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

2.5. Other activities(s): drop shipmentStreckengeschäfte

Name and address of the site: Dental Bauer GmbH & Co. KG

(ORG-100034543 / LOC-100064199)

, Jechtinger Strasse 10, St. Georgen, Freiburg Im Breisgau, Baden-Wuerttemberg, 79111, 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

2.5. Other activities(s): drop shipmentStreckengeschäfte

Zu 1.1: Handel mit Fertigarzneimitteln ausschließlich zur Zahnheilkunde (§ 47 Abs. 1 Nr. 7 Arzneimittelgesetz) und Haut- und Händedesinfektionsmitteln

Zu 2.1: Beschaffung ausschließlich durch Dental-Union GmbH, Gutenbergring 5, 7-9, 63110 Rodgau. Der körperliche Umgang mit Arzneimitteln ist nicht erlaubt.

Zu 2.3: Lieferung (Abgabe) durch Dental-Union GmbH, Gutenbergring 7-9, 63110 Rodgau und ausschließlich an zur Ausübung der Zahnheilkunde berechtigte Personen.

Zu 2.5: Handel erfolgt (teilweise) im Streckengeschäft (Handel ohne Lagerung).

Union Format for a Wholesale Distribution Authorisation	DE_BW_05_WDA_2022_0003
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