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RTF Template

Austrian Federal Office For Safety In Health Care

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products and Veterinary medicinal products

1. Authorisation Number	:	482878
2. Name of Authorisation Holder	:	Sandoz GmbH (ORG-100000546 / LOC-100000450)
3. Address(es) of Site(s)	:	Sportplatzweg 13, Unterlangkampfen, Langkampfen, Tirol, 6336, 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	:	2019-03-04
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-100038806)

, Sportplatzweg 13, Unterlangkampfen, Langkampfen, Tirol, 6336, Austria

Human medicinal products

Veterinary medicinal products

1. MEDICINAL PRODUCTS

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

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 - Außenlager Schenker & Co AG; Keine / none

Sandoz GmbH - Außenlager Schenker & Co AG; Keine / none

Union Format for a Wholesale Distribution Authorisation	482878
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