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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/roeko/05/21.05.2019
2. Name of Authorisation Holder	:	RöKoPrax GmbH
3. Address(es) of Site(s)	:	Ludwig-Erhard-Ring 18, Dahlewitz, Brandenburg, 15827, Germany

4. Legally registered address of Authorisation Holder	:	Ludwig-Erhard-Ring 18, Dahlewitz, Brandenburg, 15827, 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	:	2019-05-21
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: RöKoPrax GmbH

, Ludwig-Erhard-Ring 18, Dahlewitz, Brandenburg, 15827, 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

2.5. Other activities(s): supply on behalf of the owner commissioningLagerung und Lieferung im Kundenauftrag

Any restrictions or clarifying remarks (for all users): supply on behalf of the owner commissioning for:
• Villiè GmbH, zum Hospitalgraben 8, Weimar, Thüringen, 99425, Germany
• T2 Pharma GmbH, zum Hospitalgraben 8, Weimar, Thüringen, 99425, Germany
The wholesale takes place in rooms according to the sketch plan of 2019-01-23

Lagerung und Lieferung im Kundenauftrag für:
• Villiè GmbH, zum Hospitalgraben 8, Weimar, Thüringen, 99425, Deutschland
• T2 Pharma GmbH, zum Hospitalgraben 8, Weimar, Thüringen, 99425, Deutschland
Der Großhandel wird in den Räumen gem. den vorliegenden Lageplänen vom 23.01.2019 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/roeko/05/21.05.2019
	Page 1

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