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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_2026_0013/24.05.05.01-Nippon Sanso
2. Name of Authorisation Holder	:	Nippon Sanso Deutschland GmbH (ORG-100002980 / LOC-100002149)
3. Address(es) of Site(s)	:	Hans-Boeckler-Strasse 1, Golzheim, Duesseldorf, 40476, Germany

4. Legally registered address of Authorisation Holder	:	Hans-Boeckler-Strasse 1, Golzheim, Duesseldorf, 40476
5. Scope of authorisation	:	ANNEX 1
6. Legal basis of authorisation	:	Art. 77(1) of Directive 2001/83/EC §52a AMG
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2026-04-15
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: Nippon Sanso Deutschland GmbH

(ORG-100002980 / LOC-100002149)

, Hans-Boeckler-Strasse 1, Golzheim, Duesseldorf, 40476, 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): Restrictions or clarifications regarding the scope of the licence:
Storage takes place at the dependent operating sites listed in Annex 5.

ANNEX 5
Further regulations based on national legislation:
dependent storage facilities of Nippon Gases Deutschland GmbH
Gewerbehof 25, 73441 Bopfingen
Dieffler Str. / Am Torhaus 3, 66763 Dillingen/Saar
An der Lache 20, 99086 Erfurt
Gennerstraße 281 – 283, 50354 Hürth
Zechenstraße 6, 66333 Völklingen
Schnellerstr. 6-13, 12439 Berlin

Einschränkungen oder Klarstellungen bezüglich des Umfangs der Erlaubnis:
Die Lagerung erfolgt durch die in der Anlage 5 genannten unselbstständigen Betriebsstätten.

ANLAGE 5
Weitere Regelungen aufgrund nationaler Rechtsvorschriften:
unselbstständige Lagerstätten der Nippon Gases Deutschland GmbH
Gewerbehof 25, 73441 Bopfingen
Dieffler Str. / Am Torhaus 3, 66763 Dillingen/Saar
An der Lache 20, 99086 Erfurt
Gennerstraße 281 – 283, 50354 Hürth
Zechenstraße 6, 66333 Völklingen
Schnellerstr. 6-13, 12439 Berlin

Union Format for a Wholesale Distribution Authorisation	DE_NW_03_WDA_2026_0013/24.05.05.01-Nippon Sanso
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