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RTF Template

Bezirksregierung Koeln

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	DE_NW_04_WDA_2024-0160-01
2. Name of Authorisation Holder	:	Westfalen Medical GmbH (ORG-100040193 / LOC-100067991)
3. Address(es) of Site(s)	:	Otto-Brenner-Strasse 50, Birkesdorf, Dueren, North Rhine-Westphalia, 52353, Germany

4. Legally registered address of Authorisation Holder	:	Einheitsstrasse 3, Weidenau, Siegen, North Rhine-Westphalia, 57076
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	:	2024-07-04
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: Westfalen Medical GmbH

(ORG-100040193 / LOC-100092900)

, Otto-Brenner-Strasse 50, Birkesdorf, Dueren, North Rhine-Westphalia, 52353, Germany

Human medicinal products

1. MEDICINAL PRODUCTS

1.1. with a Marketing Authorisation or registration in EEA country(s)

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.3. Other products: (please specify here or make a reference to Annex 5) Medicinal gases Medizinische Gase

Any restrictions or clarifying remarks (for all users): The authorisation is limited to wholesale with medicinal oxygen (liquid oxygen).

Die Erlaubnis beschränkt sich auf den Großhandel mit medizinischem Sauerstoff (Flüssigsauerstoff).

Union Format for a Wholesale Distribution Authorisation	DE_NW_04_WDA_2024-0160-01
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