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RTF Template

Landesamt Fuer Gesundheit Und Soziales

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	DE_BE_01_WDA_2023_5373/1dentalbauer/02
2. Name of Authorisation Holder	:	Dental Bauer GmbH & Co.KG
3. Address(es) of Site(s)	:	Königsallee 56, Berlin, 14193, Germany

4. Legally registered address of Authorisation Holder	:	Ernst-Simon-Str. 12, Tübingen, 72072
5. Scope of authorisation	:	ANNEX 1
6. Legal basis of authorisation	:	Art. 77(1) of Directive 2001/83/EC § 52a (1) Arzneimittelgesetz AMG (german drug law )
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2023-12-01
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

, Königsallee 56, Berlin, 14193, 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): External storage in a contracted companyz.B. externe Lagerung in einem beauftragten Betrieb

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): Exclusively wholesale as part of the drop shipping business with medicinal products acc. Section 47 (1) No. 7 of the German Medicines Act, disinfectants and medical oxygen. There is no physical handling of medicinial products on this site.
On 2.1: GLS Logistik GmbH & Co Dental Handel KG, Richard-Goosen-Straße 10, 43123 Kassel
On 2.3: carried out by GLS Logistik GmbH & Co Dental Handel KG, Richard-Goosen-Straße 10, 43123 Kassel, exclusively to persons authorized to practice dentistry

Ausschließlich Großhandel im Rahmen des Streckengeschäftes mit Arzneimitteln gem. § 47 Abs. 1 Nr. 7 Arzneimittelgesetz, Desinfektionsmitteln und medizinischem Sauerstoff. In der Betriebsstätte erfolgt kein physischer Umgang mit Arzneimitteln.
Zu 2.1 auschließlich bei der GLS Logistik GmbH & Co Dental Handel KG, Richard-Goosen-Straße 10, 43123 Kassel
Zu 2.3: erfolgt durch die ausschließlich durch die GLS Logistik GmbH & Co Dental Handel KG, Richard-Goosen-Straße 10, 43123 Kassel, ausschließlich an zur Ausübung der Zahnheilkunde berechtigte Personen

Union Format for a Wholesale Distribution Authorisation	DE_BE_01_WDA_2023_5373/1dentalbauer/02
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