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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	:	483076
2. Name of Authorisation Holder	:	Sigmapharm Arzneimittel GmbH (ORG-100007909 / LOC-100011680)
3. Address(es) of Site(s)	:	Pasettistrasse 76, Brigittenau, Vienna, 1200, Austria

4. Legally registered address of Authorisation Holder	:	Leystrasse 129, Brigittenau, Vienna, 1200
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	:	1998-06-29
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: Sigmapharm Arzneimittel GmbH

(ORG-100007909 / LOC-100065996)

, Pasettistrasse 76, Brigittenau, Vienna, 1200, Austria

Human medicinal products

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.2. Holding

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

3.2.2. Other temperatures: (please specify) Temperaturen zwischen -15 bis -25°C / Temperatures between -15 to -25 °C Temperaturen zwischen -15 bis -25°C / Temperatures between -15 to -25 °C

Any restrictions or clarifying remarks (for all users): Sigmapharm Arzneimittel GmbH - Außenlager Vereinigte Eisfabriken und Kühlhallen in Wien, reg. Gen. mbH; Eingeschränkt auf die Lagerung von Arzneimitteln / Restricted to the holding of medicinal products

Sigmapharm Arzneimittel GmbH - Außenlager Vereinigte Eisfabriken und Kühlhallen in Wien, reg. Gen. mbH; Eingeschränkt auf die Lagerung von Arzneimitteln / Restricted to the holding of medicinal products

Union Format for a Wholesale Distribution Authorisation	483076
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