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RTF Template

Austrian Agency For Health And Food Safety

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products and Veterinary medicinal products

1. Authorisation Number	:	481921
2. Name of Authorisation Holder	:	Sandoz GmbH (ORG-100000546 / LOC-100000450)
3. Address(es) of Site(s)	:	Biochemiestrasse 10, Kundl, 6250, Austria

4. Legally registered address of Authorisation Holder	:	Biochemiestrasse 10, Kundl, Tyrol, 6250
5. Scope of authorisation	:	ANNEX 1
6. Legal basis of authorisation	:	Art. 77(1) of Directive 2001/83/EC Art. 99 of Regulation (EU) 2019/6
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2003-09-30
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: Sandoz GmbH

(ORG-100000546 / LOC-100000450)

, Biochemiestrasse 10, Kundl, 6250, Austria

Human medicinal products

Veterinary medicinal products

1. MEDICINAL PRODUCTS

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

1.2. without a Marketing Authorisation or registration in the EEA and intended for EEA market*

1.3. without a Marketing Authorisation or registration in the EEA and intended for exportation

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

2.4. Export

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): Sandoz GmbH - Betriebsstätte / Manufacturing Site Anti Infectives & Chemical Operations FDF Kundl (AICO FDF Kundl); Diese Bewilligung umfasst für alle angeführten Arzneiformen den Einsatz von Penicillinen und Cephalosporinen. / The corresponding Authorisation includes the handling of penicillines and cephalosporines regarding all mentioned dosage forms. Probebetrieb betreffend folgende Verfahren bis zum 30.06.2028 / Regarding the following inspection cases valid until: 30.06.2028 INS-481921-100347702 INS-481921-100912770 INS-481921-104620227

Sandoz GmbH - Betriebsstätte / Manufacturing Site Anti Infectives & Chemical Operations FDF Kundl (AICO FDF Kundl); Diese Bewilligung umfasst für alle angeführten Arzneiformen den Einsatz von Penicillinen und Cephalosporinen. / The corresponding Authorisation includes the handling of penicillines and cephalosporines regarding all mentioned dosage forms. Probebetrieb betreffend folgende Verfahren bis zum 30.06.2028 / Regarding the following inspection cases valid until: 30.06.2028 INS-481921-100347702 INS-481921-100912770 INS-481921-104620227

*Art. 5 of Directive 2001/83/EC, Art. 83 of Regulation (EC) 726/2004 and Art. 110 of Regulation 2019/6.

Union Format for a Wholesale Distribution Authorisation	481921
	Page 1

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