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RTF Template

Bezirksregierung Köln

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	DE_NW_04_WDA_2022-0030-01
2. Name of Authorisation Holder	:	Med Laborunion GmbH (ORG-100034854 / LOC-100055292)
3. Address(es) of Site(s)	:	Albert-Einstein-Strasse 13, Wehnrath, Reichshof, North Rhine-Westphalia, 51580, Germany

4. Legally registered address of Authorisation Holder	:	Albert-Einstein-Strasse 13, Wehnrath, Reichshof, North Rhine-Westphalia, 51580
5. Scope of authorisation (complete for each site under 4)	:	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 wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2022-11-08
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: Med Laborunion GmbH

(ORG-100034854 / LOC-100055292)

, Albert-Einstein-Strasse 13, Wehnrath, Reichshof, North Rhine-Westphalia, 51580, Germany

Human medicinal products

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

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Medicinal gases

Any restrictions or clarifying remarks (for all users): The WDA is limited to the wholesale of skin and hand disinfectants as well as infusion so-lutions with at least 500 ml content, rinsing solutions and medical oxygen.

Die Erlaubnis umfasst ausschließlich den Handel mit Haut- und Händedesinfektionsmit-tel, Infusionslösungen ab 500 ml, Spüllösun-gen sowie medizinischen Sauerstoff.

*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_NW_04_WDA_2022-0030-01
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