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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	:	481767
2. Name of Authorisation Holder	:	Splipharm Arzneiwaren Handels GmbH (ORG-100020641 / LOC-100042591)
3. Address(es) of Site(s)	:	Joergerstrasse 14/3-4, Waehring, Vienna, 1180, Austria

4. Legally registered address of Authorisation Holder	:	Joergerstrasse 14/3-4, Waehring, Vienna, 1180
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	:	1900-01-01
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: Splipharm Arzneiwaren Handels GmbH

(ORG-100020641 / LOC-100042591)

, Joergerstrasse 14/3-4, Waehring, Vienna, 1180, 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

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): Splipharm Arzneiwaren Handels GmbH; Probebetrieb bis 12/2027 für die Verfahren: / valid until 12/2027 for: INS-481767-101910430

Splipharm Arzneiwaren Handels GmbH; Probebetrieb bis 12/2027 für die Verfahren: / valid until 12/2027 for: INS-481767-101910430

Union Format for a Wholesale Distribution Authorisation	481767
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