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RTF Template

Ministry of Social Affairs, Health, Women and Family

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	DE_SL_01_WDA_2020_004/5011-061
2. Name of Authorisation Holder	:	Wirutec Rüsch Medical Vertriebs GmbH
3. Address(es) of Site(s)	:	Mellinweg 20, Sulzbach, 66280, Germany

4. Legally registered address of Authorisation Holder	:	Fichtenweg 3, Sulzbach, 66280, Germany
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	:	2020-04-27
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: Wirutec Rüsch Medical Vertriebs GmbH (Lager)

, Mellinweg 20, Sulzbach, 66280, Germany

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

Any restrictions or clarifying remarks (for all users): The pharmaceutical wholesaling business exclusively covers the purchase of catheter sets with enclosed medicinal products (Instillagel and Sepso J) from the company Wagner Klinikbedarf, the storage of these sets and the delivery to the hospital pharmacies in Mainz and Homburg.

The WDA also includes the Distribution of disinfectans.

Das Arzneimittelgroßhandelsgeschäft umfasst ausschließlich den Bezug von Katheter-Sets mit beigelegten Arzneimitteln (Instillagel und Sepso J) von der Fa. Wagner Klinikbedarf, die Lagerung dieser Sets sowie die Abgabe an die Krankenhausapotheken in Mainz und Homburg.

Darüber hinaus umfasst die GHE den Handel mit Desinfektionsmitteln.

*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	DE_SL_01_WDA_2020_004/5011-061
	Page 1

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