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RTF Template

Department of Occupational Health and Safety, Customer Protection and Health

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	G3-5423/dension/01/17.05.2016
2. Name of Authorisation Holder	:	Dension Dental GmbH & Co. KG
3. Address(es) of Site(s)	:	Uhlandstr. 53, Cottbus, Brandenburg, 03050, Germany

4. Legally registered address of Authorisation Holder	:	Berliner Straße 40, Offenbach, 63065, Germany
5. Scope of authorisation	:	ANNEX 1
6. Legal basis of authorisation	:
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2016-05-17
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: Dension Dental GmbH & Co. KG Betriebsstätte Cottbus

, Uhlandstr. 53, Cottbus, Brandenburg, 03050, Germany

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): The wholesale takes place in rooms according to the sketch plans Nr. Dension 1 ogf 2014-08-06
The company site disposes of no storerooms. The medicaments are sent by the mother's company in Offenbach directly to the dentists. Taken back medicaments are sent by the customer directly to the mother's company in Offenbach.

Der Großhandel wird in den Räumen gem. dem vorliegenden Lageplan Nr. Dension 1 vom 06.08.2014 durchgeführt.

Die Betriebsstätte verfügt über keine Lagerräume., Die Arzneimittel werden von der Mutterfirma in Offenbach direkt an die Zahnärzte gesandt. Zurückgenommene Arzneimittel werden vom Kunden direkt an die Mutterfirma in Offenbach gesandt.

Union Format for a Wholesale Distribution Authorisation	G3-5423/dension/01/17.05.2016
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