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RTF Template

Austrian Federal Office For Safety In Health Care

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	482897
2. Name of Authorisation Holder	:	Dentsply Sirona Europe GmbH (ORG-100036965 / LOC-100058415)
3. Address(es) of Site(s)	:	Sirona Strasse 1, Himmelreich, Wals-Siezenheim, Salzburg, 5071, Austria

4. Legally registered address of Authorisation Holder	:	Sirona Strasse 1, Himmelreich, Wals-Siezenheim, Salzburg, 5071, Austria
5. Scope of authorisation	:	ANNEX 1
6. Legal basis of authorisation	:	Art. 77(1) of Directive 2001/83/EC
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2019-02-19
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: Dentsply Sirona Europe GmbH

(ORG-100036965 / LOC-100058415)

, Sirona Strasse 1, Himmelreich, Wals-Siezenheim, Salzburg, 5071, Austria

Human 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

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2.1. Temperatures between 2 to 8 °C

Any restrictions or clarifying remarks (for all users): Dentsply Sirona Europe GmbH; Eingeschränkt auf den Bürobetrieb / Restricted to office operations

Dentsply Sirona Europe GmbH; Eingeschränkt auf den Bürobetrieb / Restricted to office operations

Union Format for a Wholesale Distribution Authorisation	482897
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