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RTF Template

Landesdirektion Sachsen

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	DE_SN_01/L24-5117/48
2. Name of Authorisation Holder	:	Dental 2000 Full-Service-Center GmbH & Co. KG
3. Address(es) of Site(s)	:	Hohmannstraße 6, Leipzig, 04129, Germany

4. Legally registered address of Authorisation Holder	:	Grietgasse 11, Jena, 07743, Germany
5. Scope of authorisation (complete for each site under 4)	:	ANNEX 1
6. Legal basis of authorisation	:
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2015-07-21
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 2000 Full-Service-Center GmbH & Co. KG

, Hohmannstraße 6, Leipzig, 04129, Germany

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

Any restrictions or clarifying remarks (for all users): This authorisation does not cover the authorisation to any physical handling of medicinal products within the authorised site.

Diese Erlaubnis umfasst nicht die Erlaubnis zum körperlichen Umgang mit Arzneimitteln in der Betriebsstätte, für die die Erlaubnis erteilt wurde.

*Art 5 of Directive 2001/83/EC or Art 83 of Regulation EC/726/2004

**Without prejudice to further authorisations as may be required according to national legislation

Union Format for a Wholesale Distribution Authorisation	DE_SN_01/L24-5117/48
	Page 1

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