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RTF Template

Regierung Von Oberfranken

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	DE_BY_05_WDA_2025_ROF-SG55.2-2675.3-154-2-11
2. Name of Authorisation Holder	:	BTC Europe GmbH (ORG-100035074 / LOC-100055621)
3. Address(es) of Site(s)	:	Industriestrasse 20, Burgbernheim, Bavaria, 91593, Germany

4. Legally registered address of Authorisation Holder	:	Rheinpromenade 1, Monheim Am Rhein, North Rhine-Westphalia, 40789
5. Scope of authorisation	:	ANNEX 1
6. Legal basis of authorisation	:	Art. 77(1) of Directive 2001/83/EC
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2025-04-22
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: BTC Europe GmbH

(ORG-100035074 / LOC-100062270)

, Industriestrasse 20, Burgbernheim, Bavaria, 91593, Germany

Human medicinal products

1. MEDICINAL PRODUCTS

1.2. without a Marketing Authorisation or registration in the EEA and intended for EEA market*

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

2.4. Export

Any restrictions or clarifying remarks (for all users): The warehouses are located in Industriestraße 11 and 17 in 91593 Burgbernheim.

Die Warenlager befinden sich in der Industriestraße 11 und 17 in 91593 Burgbernheim.

*Art. 5 of Directive 2001/83/EC, Art. 83 of Regulation (EC) 726/2004 and Art. 110 of Regulation 2019/6.

Union Format for a Wholesale Distribution Authorisation	DE_BY_05_WDA_2025_ROF-SG55.2-2675.3-154-2-11
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