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RTF Template

Austrian Medicines and Medical Devices Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	482205
2. Name of Authorisation Holder	:	VIVISOL Heimbehandlungsgeräte GmbH
3. Address(es) of Site(s)	:	Gewerbepark 13, Pfaffenhofen, 6405, Austria

4. Legally registered address of Authorisation Holder	:	Richard Strauss Straße 10, Wien, 1230, Austria
5. Scope of authorisation (complete for each site under 4)	:	ANNEX 1
6. Legal basis of authorisation	:
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2010-07-27
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: VIVISOL Heimbehandlungsgeräte GmbH

, Gewerbepark 13, Pfaffenhofen, 6405, Austria

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Medicinal gases

Any restrictions or clarifying remarks (for all users): Probebetrieb bis / valid until 12/2019

*Art 5 of Directive 2001/83/EC or Art 83 of Regulation EC/726/2004

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

Union Format for a Wholesale Distribution Authorisation	482205
	Page 1

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