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RTF Template

Austrian Agency For Health And Food Safety

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	480025
2. Name of Authorisation Holder	:	Csl Behring GmbH (ORG-100002636 / LOC-100048685)
3. Address(es) of Site(s)	:	Austria Campus 6, Walcherstrasse 1a/Stiege 1, Leopoldstadt, Vienna, 1020, Austria

4. Legally registered address of Authorisation Holder	:	Austria Campus 6, Walcherstrasse 1a/Stiege 1, Leopoldstadt, Vienna, 1020
5. Scope of authorisation	:	ANNEX 1
6. Legal basis of authorisation	:	Art. 77(1) of Directive 2001/83/EC
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2002-04-23
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: CSL Behring GmbH

(ORG-100002636 / LOC-100048685)

, Austria Campus 6, Walcherstrasse 1a/Stiege 1, Leopoldstadt, Vienna, 1020, Austria

Human medicinal products

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

Any restrictions or clarifying remarks (for all users): CSL Behring GmbH; Eingeschränkt auf den Bürobetrieb / Restricted to office operations

CSL Behring GmbH; Eingeschränkt auf den Bürobetrieb / Restricted to office operations

Union Format for a Wholesale Distribution Authorisation	480025
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