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RTF Template

Department of Occupational Health and Safety, Customer Protection and Health

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	G3-5423/Arcadus/01/09.05.2016
2. Name of Authorisation Holder	:	Arcadus Pharma GmbH
3. Address(es) of Site(s)	:	Berliner Straße 8, bei dem Großhändler Rhenus SE & Co. KG, Velten, Brandenburg, 16727, Germany

4. Legally registered address of Authorisation Holder	:	Berliner Straße 8, bei dem Großhändler Rhenus SE & Co. KG, Velten, Brandenburg, 16727, 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	:	2016-05-09
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: Arcadus Pharma GmbH

, Berliner Straße 8, bei dem Großhändler Rhenus SE & Co. KG, Velten, Brandenburg, 16727, 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

2.2. Holding

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): wholesale takes place in rooms according to the sketch plans:

Nr. 01 of 2013-12 (hall 4.3 and hall 4.4)
und
Nr. 02 of 2013-10 (hall 6.4).

Der Großhandel wird in den Räumen gem. den vorliegenden Lageplänen
Lageplan Nr. 01 vom 12.2013 (Halle 4.3 und Halle 4.4) und
Lageplan Nr. 02 vom 10.2013 (Halle 6.4)
durchgeführt.

*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	G3-5423/Arcadus/01/09.05.2016
	Page 1

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