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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	:	482245
2. Name of Authorisation Holder	:	Janssen-Cilag Pharma GmbH (ORG-100002240 / LOC-100008010)
3. Address(es) of Site(s)	:	Vorgartenstrasse 206b, Leopoldstadt, Vienna, 1020, Austria

4. Legally registered address of Authorisation Holder	:	Vorgartenstrasse 206b, Leopoldstadt, Vienna, 1020, 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	:	2010-12-02
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: Janssen-Cilag Pharma GmbH

(ORG-100002240 / LOC-100008010)

, Vorgartenstrasse 206b, 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

3.1. Narcotic or psychotropic products**

3.2.1. Temperatures between 2 to 8 °C

3.2.2. Other temperatures: (please specify) Temperatur / temperature ≤-120°C Temperatur / temperature ≤-120°C

3.3. Other products: (please specify here or make a reference to Annex 5) CAR-T Zellprodukt CAR-T Zellprodukt

Any restrictions or clarifying remarks (for all users): Janssen-Cilag Pharma GmbH; Eingeschränkt auf den Bürobetrieb / Restricted to office operations

Janssen-Cilag Pharma GmbH; Eingeschränkt auf den Bürobetrieb / Restricted to office operations

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

Union Format for a Wholesale Distribution Authorisation	482245
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