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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	:	484291
2. Name of Authorisation Holder	:	Vetviva Richter GmbH (ORG-100045530 / LOC-100075028)
3. Address(es) of Site(s)	:	Durisolstrasse 14, Lichtenegg, Wels, Oberoesterreich, 4600, Austria

4. Legally registered address of Authorisation Holder	:	Durisolstrasse 14, Lichtenegg, Wels, Oberoesterreich, 4600, 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	:	2023-02-15
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: Vetviva Richter GmbH

(ORG-100045530 / LOC-100075028)

, Durisolstrasse 14, Lichtenegg, Wels, Oberoesterreich, 4600, 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*

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1. Narcotic or psychotropic products**

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

Any restrictions or clarifying remarks (for all users): Vetviva Richter GmbH; Übernahme sämtlicher Aktivitäten in Zusammenhang mit der Herstellung und Kontrolle von Arzneimitteln der Richter Pharma AG am Standort Durisolstraße 14 durch VetViva Richter GmbH. Die Räumlichkeiten, Ausrüstung und Prozesse werden unverändert weitergeführt. / Transfer of all Manufacturing and Quality Control activites at the site Durisolstraße 14 from Richter Pharma AG to VetViva Richter GmbH. The manufacturing site, all manufacturing operations and production lines remain unchanged. Probebetrieb bis zum: / valid until: 31.12.2027

Vetviva Richter GmbH; Übernahme sämtlicher Aktivitäten in Zusammenhang mit der Herstellung und Kontrolle von Arzneimitteln der Richter Pharma AG am Standort Durisolstraße 14 durch VetViva Richter GmbH. Die Räumlichkeiten, Ausrüstung und Prozesse werden unverändert weitergeführt. / Transfer of all Manufacturing and Quality Control activites at the site Durisolstraße 14 from Richter Pharma AG to VetViva Richter GmbH. The manufacturing site, all manufacturing operations and production lines remain unchanged. Probebetrieb bis zum: / valid until: 31.12.2027

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

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

Union Format for a Wholesale Distribution Authorisation	484291
	Page 1

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