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RTF Template

Regional Council Darmstadt

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	DE_HE_01_WDA_2019_0013
2. Name of Authorisation Holder	:	GPR Klinikum Rüsselsheim
3. Address(es) of Site(s)	:	August-Bebel-Straße 59, Rüsselsheim, 65428, Germany

4. Legally registered address of Authorisation Holder	:	August-Bebel-Straße 59, Rüsselsheim, 65428, 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	:	2019-02-13
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: GPR Klinikum Rüsselsheim - Institut für Laboratoriumsmedizin

, August-Bebel-Straße 59, Rüsselsheim, 65428, 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): Ad 3: Wholesale of medicinal products from blood (erythrocyte concentrates, platelet concentrates) in accordance with Directive 2002/98 EC
Blood Depot: Building A, Room 25.240
Archive room: Building N, Level 2, Room N2.060

Zu 3: Großhandel mit Arzneimitteln aus Blut (Erythrozytenkonzentrate, Thrombozytenkonzentrate) gemäß der Richtlinie 2002/98 EG
Blutdepot: Gebäude A, Raum 25.240
Archivraum: Gebäude N, Ebene 2, Raum N2.060

*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_2019_0013
	Page 1

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