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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/BMTF/02/29.09.2016
2. Name of Authorisation Holder	:	Biomedizinische Technik Frankfurt/Oder
3. Address(es) of Site(s)	:	Witebsker Straße 28, Frankfurt/Oder, Brandenburg, 15234, Germany

4. Legally registered address of Authorisation Holder	:	Witebsker Straße 28, Frankfurt/Oder, Brandenburg, 15234, 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	:	2016-09-29
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: Biomedizinische Technik Frankfurt/Oder

, Witebsker Straße 28, Frankfurt/Oder, Brandenburg, 15234, 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

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

BMTF 01 of 2006-02-22

The wholesale permission is limited to distribution of skin disinfection and infusion solution (from 500 ml)

Der Großhandel wird in den Räumen gem. dem vorliegenden Lageplan
BMTF 01 vom 22.02.2006 durchgeführt.

Die Großhandelserlaubnis ist auf den Vertrieb von Hautdesinfektion und Infusionslösungen (ab 500 ml) beschränkt

*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/BMTF/02/29.09.2016
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