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RTF Template

Landesamt Fuer Soziales Jugend Und Versorgung

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	DE_RP_01_WDA_2024_54.1/GDP/138-004
2. Name of Authorisation Holder	:	Lohmann & Rauscher GmbH & Co. KG (ORG-100052710 / LOC-100092858)
3. Address(es) of Site(s)	:	Heilsberger Strasse 16, Block, Neuwied, Rhineland-Palatinate, 56566, Germany Westerwaldstrasse 4, Rengsdorf, Rhineland-Palatinate, 56579, Germany

4. Legally registered address of Authorisation Holder	:	Irlicher Strasse 55, Feldkirchen, Neuwied, Rhineland-Palatinate, 56567, Germany
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	:	2024-10-17
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: Lohmann & Rauscher GmbH & Co. KG

(ORG-100052710 / LOC-100093062)

, Heilsberger Strasse 16, Block, Neuwied, Rhineland-Palatinate, 56566, 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

Any restrictions or clarifying remarks (for all users): The authorisation is limited to disinfectants and infusion solutions according to Section 47, Paragraph 1, No. 2c AMG, including container sizes smaller than 500 ml.

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Restrictions or remarks in National Language:
Das Arzneimittelsortiment beschränkt sich auf Desinfektionsmittel und Infusionslösungen gem. § 47 Abs. 1 Nr. 2c AMG, jedoch diese zusätzlich auch in Gebindegrößen kleiner als 500 ml.

Name and address of the site: Lohmann & Rauscher GmbH & Co. KG

(ORG-100052710 / LOC-100093061)

, Westerwaldstrasse 4, Rengsdorf, Rhineland-Palatinate, 56579, Germany

Human medicinal products

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.5. Other activities(s): only administrative activitiesnur Verwaltungstätigkeiten

*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_RP_01_WDA_2024_54.1/GDP/138-004
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