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RTF Template

Bezirksregierung Düsseldorf

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	DE_NW_03_WDA_2019_0006/ 24.05.05.01-CS Diagnostics
2. Name of Authorisation Holder	:	CS Diagnostics GmbH
3. Address(es) of Site(s)	:	Stresemannallee 4c, Neuss, 41460, Germany

4. Legally registered address of Authorisation Holder	:	Stresemannallee 4c, Neuss, 41460, 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	:	2019-03-25
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: CS Diagnostics GmbH

, Stresemannallee 4c, Neuss, 41460, 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

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.1. Narcotic or psychotropic products

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): Die Erlaubnis wird mit der Einschränkung erteilt, dass keine Lagerung von Arzneimitteln in der oben genannten Betriebsstätte erlaubt ist. Die Lagerung erfolgt durch den in der Anlage 2 genannten beauftragten Betrieb.
Zu 3.1.1: vorbehaltlich einer entsprechenden Erlaubnis nach § 3 BtMG

ANLAGE 2
Anschrift/en und Erlaubnisnummer/n der Betriebsstätte/n beauftragter Großhändler:
DVG GmbH
Konrad-Zuse-Str. 28
41516 Grevenbroich
Die Räumlichkeiten des vorgenannten Unternehmens unterliegen der Genehmigung und Aufsicht der Bezirksregierung Düsseldorf.

*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_NW_03_WDA_2019_0006/ 24.05.05.01-CS Diagnostics
	Page 1

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