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Information Messages

The WDA has been withdrawn, withdrawn date is: 2026-06-16

RTF Template

Trade And Industry Inspection Agency Of State Of Lower Saxony

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	DE_NI_03_WDA_2023_0003
2. Name of Authorisation Holder	:	AIR LIQUIDE Medical GmbH (ORG-100000067 / LOC-100079639)
3. Address(es) of Site(s)	:	Zum Reiherhorst 10, Stelle, 21435, Germany

4. Legally registered address of Authorisation Holder	:	Hans-Boeckler-Strasse 33, Golzheim, Duesseldorf, North Rhine-Westphalia, 40476
5. Scope of authorisation	:	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 wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2023-06-05
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: AIR LIQUIDE Medical GmbH - Abfüllwerk Stelle

, Zum Reiherhorst 10, Stelle, 21435, 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): According to site plan "AIR LIQUIDE Medical GmbH, Füllwerk Stelle", stated June 2020.

To No 1, only:
Aer medicalis 100 % (V/V) - Zulassungsnummer: 6716684.00.00
Distickstoffmonoxid medicAL 100 % (V/V) - nach Standardzulassung
PulmixAL 0,25 % (V/V)/18 % (V/V) - Zulassungsnummer: 75185.00.00
PulmixAL 0,28 % (V/V)/9,5 % (V/V) - Zulassungsnummer: 75186.00.00
ProMED pul-p C2H2/CH4/CO 0,3% (V/V)/ 0,3% (V/V)/ 0,3% (V/V) - Zulassungsnummer: 75110.00.00

To No 2.1:
Procurement takes place centrally via site Wittenberg

Gemäß dem vorliegenden Lageplan "AIR LIQUIDE Medical GmbH, Füllwerk Stelle", Stand Juni 2020.

Zu Nr. 1, ausschließlich:
Aer medicalis 100 % (V/V) - Zulassungsnummer: 6716684.00.00
Distickstoffmonoxid medicAL 100 % (V/V) - nach Standardzulassung
PulmixAL 0,25 % (V/V)/18 % (V/V) - Zulassungsnummer: 75185.00.00
PulmixAL 0,28 % (V/V)/9,5 % (V/V) - Zulassungsnummer: 75186.00.00
ProMED pul-p C2H2/CH4/CO 0,3% (V/V)/ 0,3% (V/V)/ 0,3% (V/V) - Zulassungsnummer: 75110.00.00

Zu Nr. 2.1:
Die Beschaffung erfolgt zentral über die Betriebsstätte Wittenberg

Reason for Withdrawing:

Return of WDA for site in Stelle (Zum Reiherhorst 10), Old 2026-06-16

Betriebsstätte im Zuständigkeitsgebiet aufgrund von lediglich Tätigkeiten als nicht selbstständiges Lager in zentraler Erlaubnis aufgenommen. Rückgabe der Großhandelserlaubnis. Old 16.06.2026

Union Format for a Wholesale Distribution Authorisation	DE_NI_03_WDA_2023_0003
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