1. Authorisation Number

:

5.9.4-2022-107209

2. Name of Authorisation Holder

:

Maquet Critical Care AB

(ORG-100019924 / LOC-100028654)

3. Address(es) of Site(s)

:

Rontgenvagen 2, Solna, 171 54, Sweden 

4. Legally registered address of Authorisation Holder

:

Rontgenvagen 2, Solna, 171 54

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

:

2023-01-12

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

Name and address of the site: Maquet Critical Care AB

(ORG-100019924 / LOC-100028654)

, Rontgenvagen 2, Solna, 171 54, Sweden   

Human medicinal products

Any restrictions or clarifying remarks (for all users):  Wholesale activities to buy and use medicinal products for inhalation and intravenous administration for research, development, testing, production and service of medical devices.

*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

5.9.4-2022-107209

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