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RTF Template

Landesdirektion Sachsen

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	DE_SN_01/L24.2-5115/1046
2. Name of Authorisation Holder	:	Klinikum St. Georg gGmbH
3. Address(es) of Site(s)	:	Delitzscher Strasse 141, Leipzig, Sachsen, 04129, Germany

4. Legally registered address of Authorisation Holder	:	Delitzscher Straße 141, Leipzig, 04129, 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	:	2018-04-26
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: Klinikum St. Georg gGmbH, Zentrum für Klinische Chemie, Mikrobiologie und Transfusionsmedizin, Institut fuer Transfusionsmedizin und Klinische Haemostaseologie

, Delitzscher Strasse 141, Leipzig, Sachsen, 04129, 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

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.2. Medicinal products derived from blood

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): The authorisation includes the wholesale distribution of whole blood, plasma and blood cells of human origin in accordance with Directive 2002/98/EC.

Die Erlaubnis umfasst auch den Großhandel mit Vollblut, Plasma und Blutzellen menschlichen Ursprungs gemäß Richtlinie 2002/98/EG.

*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_SN_01/L24.2-5115/1046
	Page 1

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