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RTF Template

Austrian Agency For Health And Food Safety

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	482954
2. Name of Authorisation Holder	:	Die Ruster Apotheke KG (ORG-100048297 / LOC-100079934)
3. Address(es) of Site(s)	:	Oggauerstrasse 22, Rust, 7071, Austria

4. Legally registered address of Authorisation Holder	:	Oggauerstrasse 22, Rust, Burgenland, 7071
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	:	2019-07-25
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: Die Ruster Apotheke KG

(ORG-100048297 / LOC-100079934)

, Oggauerstrasse 22, Rust, 7071, 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

2.2. 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

3.3. Other products: (please specify here or make a reference to Annex 5) aus Blut gewonnene Arzneimittel; immunologische Arzneimittel aus Blut gewonnene Arzneimittel; immunologische Arzneimittel

Any restrictions or clarifying remarks (for all users): Die Ruster Apotheke KG; gültig bis: / valid until: 31.12.2028

Die Ruster Apotheke KG; gültig bis: / valid until: 31.12.2028

Union Format for a Wholesale Distribution Authorisation	482954
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