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RTF Template

Landesamt Fuer Gesundheit Und Soziales

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	DE_BE_01_WDA_2023_5373/1-Westfalen Medical/01
2. Name of Authorisation Holder	:	Westfalen Medical GmbH (ORG-100040193 / LOC-100077388)
3. Address(es) of Site(s)	:	Romain-Rolland-Strasse 14, Heinersdorf, Berlin, 13089, Germany

4. Legally registered address of Authorisation Holder	:	Romain-Rolland-Strasse 14, Heinersdorf, Berlin, 13089
5. Scope of authorisation (complete for each site under 4)	:	ANNEX 1
6. Legal basis of authorisation	:	§ 52a (1) Arzneimittelgesetz AMG (german drug law )
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2023-01-18
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-100077388)

, Romain-Rolland-Strasse 14, Heinersdorf, Berlin, 13089, Germany

Human medicinal products

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.2. Holding

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Medicinal gases

Any restrictions or clarifying remarks (for all users): According to the floor plan dated 2022-12-14.
Only wholesale of medical oxygen (liquid oxygen and compressed gas).

Gemäß dem Grundrissplan mit Datum vom 14.12.2022.
Die Erlaubnis beschränkt sich auf den Großhandel mit medizinischem Sauerstoff (Flüssigsauerstoff und Druckgas).

*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	DE_BE_01_WDA_2023_5373/1-Westfalen Medical/01
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