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RTF Template

Regional Council Darmstadt

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	DE_HE_01_WDA_2018_0072
2. Name of Authorisation Holder	:	Fresenius Medical Care Deutschland GmbH
3. Address(es) of Site(s)	:	Else-Kroener-Strasse 1, Bad Homburg v.d.H., Hessen, 61352, Germany Eduard-Fresenius-Strasse 1, Biebesheim, Hessen, 64584, Germany

4. Legally registered address of Authorisation Holder	:	Else-Kroener-Strasse 1, Bad Homburg v.d.H., Hessen, 61352, 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	:	2018-07-30
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: Fresenius Medical Care Deutschland GmbH

, Else-Kroener-Strasse 1, Bad Homburg v.d.H., Hessen, 61352, Germany

1. MEDICINAL PRODUCTS

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

1.3. without a Marketing Authorisation in the EEA and intended for exportation

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.3. Supply

2.4. Export

2.5. Other activities(s): holding and supply as outsourced activities in external warehouses (see annex 5)Lagerung und Lieferung in beauftragten Betrieben (siehe Anlage 5)

Any restrictions or clarifying remarks (for all users): none

keine

Name and address of the site: Fresenius Medical Care Deutschland GmbH

, Eduard-Fresenius-Strasse 1, Biebesheim, Hessen, 64584, Germany

1. MEDICINAL PRODUCTS

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

1.3. without a Marketing Authorisation in the EEA and intended for exportation

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.2. Holding

2.3. Supply

Any restrictions or clarifying remarks (for all users): none

keine

*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_2018_0072
	Page 1

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