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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/ Aresus/01/04.12.2019
2. Name of Authorisation Holder	:	Aresus Pharma GmbH
3. Address(es) of Site(s)	:	Kastanienallee 46, Strausberg, 15344, Germany

4. Legally registered address of Authorisation Holder	:	Kastanienallee 46, Strausberg, 15344, 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	:	2019-12-04
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: Aresus Pharma GmbH

, Kastanienallee 46, Strausberg, 15344, 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

3.4. Other products: Pharmaceutic entrepreneur Pharmazeutischer Unternehmer

Any restrictions or clarifying remarks (for all users): Wholesale is carried out in the rooms in accordance with the present floor plans of 02.11.2019.

Storage and transport are outsourced activities.

Der Großhandel wird in den Räumen gemäß den vorliegenden Grundrissplänen vom 02.11.2019 durchgeführt.

Lagerung und Transport sind ausgelagerte Tätigkeiten.

*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/ Aresus/01/04.12.2019
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