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RTF Template

Austrian Federal Office For Safety In Health Care

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	482383
2. Name of Authorisation Holder	:	Exeltis Austria GmbH (ORG-100036953 / LOC-100058382)
3. Address(es) of Site(s)	:	Judenplatz 7/2, Innere Stadt, Vienna, 1010, Austria

4. Legally registered address of Authorisation Holder	:	Judenplatz 7/2, Innere Stadt, Vienna, 1010, Austria
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	:	2013-04-03
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: Exeltis Austria GmbH

(ORG-100036953 / LOC-100058382)

, Judenplatz 7/2, Innere Stadt, Vienna, 1010, 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

2.2. Holding

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2.1. Temperatures between 2 to 8 °C

Any restrictions or clarifying remarks (for all users): Exeltis Austria GmbH; ad 2.2: Eingeschränkt auf die Lagerung von Ärztemustern an anderen Adressen, als der in der eigenen Betriebsbewilligung genannten Adresse (Außendienstmitarbeiter:innen) / restriced to the storage of medicinal samples at addresses other than the address specified in the Wholesale Distribution Authorisation (sales representatives)

Exeltis Austria GmbH; ad 2.2: Eingeschränkt auf die Lagerung von Ärztemustern an anderen Adressen, als der in der eigenen Betriebsbewilligung genannten Adresse (Außendienstmitarbeiter:innen) / restriced to the storage of medicinal samples at addresses other than the address specified in the Wholesale Distribution Authorisation (sales representatives)

Union Format for a Wholesale Distribution Authorisation	482383
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