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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	:	482084
2. Name of Authorisation Holder	:	Rokitan GmbH (ORG-100001987 / LOC-100003335)
3. Address(es) of Site(s)	:	Grosse Mohrengasse 10, Leopoldstadt, Vienna, 1020, Austria

4. Legally registered address of Authorisation Holder	:	Grosse Mohrengasse 10, 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	:	2010-02-09
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: Rokitan GmbH

(ORG-100001987 / LOC-100003335)

, Grosse Mohrengasse 10, 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

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): Rokitan GmbH; Eingeschränkt auf den Bürobetrieb / Restricted to office operations

Rokitan GmbH; Eingeschränkt auf den Bürobetrieb / Restricted to office operations

Union Format for a Wholesale Distribution Authorisation	482084
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