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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	:	482119
2. Name of Authorisation Holder	:	UCB Pharma Ges.m.b.H. (ORG-100005874 / LOC-100102688)
3. Address(es) of Site(s)	:	Gertrude-Froehlich-Sandner-Strasse 2-4, Favoriten, Vienna, 1100, Austria

4. Legally registered address of Authorisation Holder	:	Gertrude-Froehlich-Sandner-Strasse 2-4, Favoriten, Vienna, 1100
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	:	2009-06-26
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: UCB Pharma Ges.m.b.H.

(ORG-100005874 / LOC-100102688)

, Gertrude-Froehlich-Sandner-Strasse 2-4, Favoriten, Vienna, 1100, 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

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1. Narcotic or psychotropic products**

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

Any restrictions or clarifying remarks (for all users): UCB Pharma Ges.m.b.H.; Eingeschränkt auf den Bürobetrieb / Restricted to office operations Eingeschränkt auf den Betriebsstandort: Gertrude-Fröhlich-Sandner-Straße 2-4 / Turm 9, 1100 Wien, Büro Nr. 902, Nr. 908 und Nr. 909 / Restricted to operating location: Gertrude-Fröhlich-Sandner-Straße 2-4 / Turm 9, 1100 Wien, Office No. 902, No. 908 and No. 909

UCB Pharma Ges.m.b.H.; Eingeschränkt auf den Bürobetrieb / Restricted to office operations Eingeschränkt auf den Betriebsstandort: Gertrude-Fröhlich-Sandner-Straße 2-4 / Turm 9, 1100 Wien, Büro Nr. 902, Nr. 908 und Nr. 909 / Restricted to operating location: Gertrude-Fröhlich-Sandner-Straße 2-4 / Turm 9, 1100 Wien, Office No. 902, No. 908 and No. 909

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

Union Format for a Wholesale Distribution Authorisation	482119
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