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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	:	482384
2. Name of Authorisation Holder	:	Phoenix Arzneiwarengrosshandlung GmbH (ORG-100016205 / LOC-100024982)
3. Address(es) of Site(s)	:	Dietersdorfer Strasse 10-18/H, Hagenbrunn, Niederoesterreich, 2201, Austria

4. Legally registered address of Authorisation Holder	:	Albert-Schweitzer-Gasse 3, Penzing, Vienna, 1140
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	:	2013-03-26
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: Phoenix Arzneiwarengrosshandlung GmbH

(ORG-100016205 / LOC-100041549)

, Dietersdorfer Strasse 10-18/H, Hagenbrunn, Niederoesterreich, 2201, Austria

Human medicinal products

Veterinary medicinal products

1. MEDICINAL PRODUCTS

1.1. with a Marketing Authorisation or registration in EEA country(s)

1.3. without a Marketing Authorisation or registration in the EEA and intended for exportation

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

3.2.2. Other temperatures: (please specify) Temperaturen zwischen -60 bis -80 °C und zwischen -15 bis -25°C / Temperatures between -60 to -80 °… Temperaturen zwischen -60 bis -80 °C und zwischen -15 bis -25°C / Temperatures between -60 to -80 °…

Any restrictions or clarifying remarks (for all users): PHOENIX Arzneiwarengroßhandlung GmbH; Für die Verfahren INS-482384-105418814 und INS-482384-105353961 Probebetrieb bis zum: /Regarding inspection cases INS-482384-105418814 and INS-482384-105353961 valid until: 31.12.2027

PHOENIX Arzneiwarengroßhandlung GmbH; Für die Verfahren INS-482384-105418814 und INS-482384-105353961 Probebetrieb bis zum: /Regarding inspection cases INS-482384-105418814 and INS-482384-105353961 valid until: 31.12.2027

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

Union Format for a Wholesale Distribution Authorisation	482384
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