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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	:	481135
2. Name of Authorisation Holder	:	Kepler Universitaetsklinikum GmbH (ORG-100034521 / LOC-100059405)
3. Address(es) of Site(s)	:	Krankenhausstrasse 9, Linz, Oberoesterreich, 4020, Austria

4. Legally registered address of Authorisation Holder	:	Krankenhausstrasse 7a, Linz, Oberoesterreich, 4020, Austria
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	:	1999-08-16
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: Kepler Universitaetsklinikum GmbH

(ORG-100034521 / LOC-100054737)

, Krankenhausstrasse 9, Linz, Oberoesterreich, 4020, Austria

Human medicinal products

Veterinary 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

3.2.2. Other temperatures: (please specify) Temperaturen zwischen -20 bis -40 °C und -70 bis -90 °C / Temperatures between -20 to -40 °C and -7… Temperaturen zwischen -20 bis -40 °C und -70 bis -90 °C / Temperatures between -20 to -40 °C and -7…

Any restrictions or clarifying remarks (for all users): Kepler Universitätskliniken GmbH, Anstaltsapotheke; Keine / None

Kepler Universitätskliniken GmbH, Anstaltsapotheke; Keine / None

Union Format for a Wholesale Distribution Authorisation	481135
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