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RTF Template

Landesdirektion Sachsen

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	DE_SN_01/L24.2-5117/222
2. Name of Authorisation Holder	:	CSB PHARMA GmbH
3. Address(es) of Site(s)	:	Wüstenbrander Schulstraße 11, Hohenstein-Ernstthal, 09337, Germany

4. Legally registered address of Authorisation Holder	:	Wüstenbrander Schulstraße 11, Hohenstein-Ernstthal, 09337, 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	:	2019-03-14
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: CSB PHARMA GmbH

, Wüstenbrander Schulstraße 11, Hohenstein-Ernstthal, 09337, Germany

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Medicinal gases

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): In relation to medicinal products which should be stored at "cold" or "freezing" conditions, this authorisation is valid only under the terms specified in the official letter issued by Landesdirektion Sachsen on 28 November 2014.

Diese Erlaubnis gilt in Bezug auf kühl oder tiefgekühlt zu lagernde Arzneimittel nur unter der im Bescheid der Landesdirektion Sachsen vom 28. November 2014 enthaltenen Auflage.

*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/L24.2-5117/222
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