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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	:	482937
2. Name of Authorisation Holder	:	Octapharma Pharmazeutika Produktionsgesellschaft mbH (ORG-100000247 / LOC-100006057)
3. Address(es) of Site(s)	:	Pasettistrasse 76, Brigittenau, Vienna, 1200, Austria

4. Legally registered address of Authorisation Holder	:	Oberlaaer Strasse 235, Favoriten, Vienna, 1100
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	:	2019-04-15
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: Octapharma Pharmazeutika Produktionsgesellschaft mbH

(ORG-100000247 / LOC-100065540)

, Pasettistrasse 76, Brigittenau, Vienna, 1200, Austria

Human 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

2.2. Holding

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Products requiring low temperature handling

3.2.2. Other temperatures: (please specify) -20° C bis - 30° C -20° C bis - 30° C

Any restrictions or clarifying remarks (for all users): Octapharma Pharmazeutika Produktionsgesellschaft m.b.H. - Außenlager Vereinigte Eisfabriken und Kühlhallen in Wien reg. Gen. m. b. H.; Keine / none

Octapharma Pharmazeutika Produktionsgesellschaft m.b.H. - Außenlager Vereinigte Eisfabriken und Kühlhallen in Wien reg. Gen. m. b. H.; Keine / none

Union Format for a Wholesale Distribution Authorisation	482937
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