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RTF Template

Bezirksregierung Duesseldorf

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	DE_NW_03_WDA_2023_0006/24.05.05.01-Aguettant
2. Name of Authorisation Holder	:	Aguettant Deutschland GmbH (ORG-100010116 / LOC-100016862)
3. Address(es) of Site(s)	:	Hans-Böckler-Str. 24, Langenfeld, 40764, Germany

4. Legally registered address of Authorisation Holder	:	Hans-Böckler-Straße 24, Berghausen, Langenfeld (rheinland), North Rhine-Westphalia, 40764
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	:	2023-02-15
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: Aguettant Deutschland GmbH

, Hans-Böckler-Str. 24, Langenfeld, 40764, 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

2.3. Supply

Any restrictions or clarifying remarks (for all users): Storage of human medicinal products is not permitted. Storage is carried out by the site mentioned in Appendix 2:
SK Pharma Logistics GmbH
Remusweg 8
33729 Bielefeld

Lagerung von Arzneimitteln in der o.g. Betriebsstätte nicht gestattet. Die Lagerung erfolgt durch den in der Anlage 2 genannten Betrieb.
Anlage 2/Annex 2:
Anschrift der Betriebsstätte des Großhändlers:
SK Pharma Logistics GmbH
Remusweg 8
33729 Bielefeld

*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_03_WDA_2023_0006/24.05.05.01-Aguettant
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