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RTF Template

Department of drug and pharmacy supervision

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	DE_ST_01_WDA_2018_032
2. Name of Authorisation Holder	:	C. Klöss Dental GmbH & Co. Betriebs KG
3. Address(es) of Site(s)	:	Krausenstraße 23, Halle (Saale), 06112, Germany

4. Legally registered address of Authorisation Holder	:	Weitzesweg 22 - 24, Bad Vilbel, 61118, 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	:	2018-09-12
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: C. Klöss Dental GmbH & Co. Betriebs KG

, Krausenstraße 23, Halle (Saale), 06112, 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): - National legal basis of the authorisation: Section 52a (1) German Drug Law (AMG)
- only drop-shipping, autorised wholesale distributer: Dental-Union GmbH, Gutenbergring 7-9, 63110 Rodgau / Nieder-Roden, Germany
- ref. 1.1: only skin and hand disinfectants, infusion solutions according to § 47 para. 1 no. 2 c) AMG and medicines for use by dentists according to § 47 para. 1 no. 7 AMG
- ref. 2.3: delivery only to doctors and dentists
- wholesale activities only in the rooms according to the present site plan dated 22.01.2009

- Nationale Rechtsgrundlage für die Erlaubnis: § 52a Abs. 1 des Arzneimittelgesetzes (AMG)
- nur Streckengeschäfte, beauftragter Betrieb: Dental-Union GmbH, Gutenbergring 7-9, 63110 Rodgau / Nieder-Roden, Deutschland
- zu 1.1: nur Haut- und Händedesinfektionsmittel, Infusionslösungen nach § 47 Abs. 1 Nr. 2 c) AMG und Arzneimittel zur Anwendung durch Zahnärzte nach § 47 Abs. 1 Nr. 7 AMG
- zu 2.3: Abgabe nur an Ärzte und Zahnärzte
-Großhandelstätigkeiten nur in den Räumen gemäß vorliegenden Lageplan vom 22.01.2009

Union Format for a Wholesale Distribution Authorisation	DE_ST_01_WDA_2018_032
	Page 1

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