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RTF Template

Regional Council Darmstadt

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	DE_HE_01_WDA_2021_0009
2. Name of Authorisation Holder	:	IKTZ Institut für Klinische Transfusionsmedizin und Zelltherapie Heidelberg gGmbH
3. Address(es) of Site(s)	:	IKTZ Heidelberg gGmbH c/o Labor des Kreiskrankenhauses Bergstraße, Viernheimer Straße 2, Heppenheim, 64646, Germany

4. Legally registered address of Authorisation Holder	:	Im Neuenheimer Feld 305, Heidelberg, 69120, 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	:	2021-03-03
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: IKTZ*

, IKTZ Heidelberg gGmbH c/o Labor des Kreiskrankenhauses Bergstraße, Viernheimer Straße 2, Heppenheim, 64646, 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

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): To 2.2:
Blood storage refrigerator No. 70003-01586 (Kirsch BL_720) and
Plasma storage cabinet No. 2355038 (Electrolux MF 280) in the laboratory area
Office space for archiving

To 3:
Wholesale of medicinal products from blood (red blood cell concentrates and fresh frozen plasma) in accordance with Directive 2002/98 EC

Zu 2.2:
Blutkonservenkühlschrank Nr. 70003-01586 (Kirsch BL_720) und
Plasmalagerschrank Nr. 2355038 (Electrolux MF 280) im Laborbereich
Büroraum zur Archivierung

Zu 3:
Großhandel mit Arzneimitteln aus Blut (Erythrozytenkonzentrate und Gefrorenes Frischplasma) gemäß der 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_HE_01_WDA_2021_0009
	Page 1

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