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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/bayer/01/17.05.2016
2. Name of Authorisation Holder	:	Bayer Pharma AG
3. Address(es) of Site(s)	:	Berliner Strasse 8, Velten, Brandenburg, 16727, Germany

4. Legally registered address of Authorisation Holder	:	Muellerstrasse 178, Berlin, Berlin, 13353, 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	:	2016-05-17
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: Bayer Pharma AG

, Berliner Strasse 8, 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

2.2. Holding

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.2. Medicinal products derived from blood

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): The wholesale takes place in rooms according to the sketch plans Nr. 23-07402 of 2013-10-02.

Der Großhandel wird in den Räumen gem. dem vorliegenden Lageplan
Nr. 23-07402 vom 02.10.2013 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/bayer/01/17.05.2016
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