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Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-03-28

RTF Template

Hessian Office For Health And Care

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	DE_HE_01_WDA_2024_0025
2. Name of Authorisation Holder	:	Novavax DE GmbH (ORG-100052138 / LOC-100091755)
3. Address(es) of Site(s)	:	Bruesseler Strasse 1-3, Gallusviertel, Frankfurt Am Main, 60327, Germany

4. Legally registered address of Authorisation Holder	:	Bruesseler Strasse 1-3, Gallusviertel, Frankfurt Am Main, 60327, Germany
5. Scope of authorisation	:	ANNEX 1
6. Legal basis of authorisation	:	Sect 52a para 1 German Medicinal Product Act
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2024-07-08
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: Novavax DE GmbH

(ORG-100052138 / LOC-100091755)

, Bruesseler Strasse 1-3, Gallusviertel, Frankfurt Am Main, 60327, 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

2.5. Other activities(s): Holding and Supply as an outsourced activity by a Contract Wholesale DistributorLagerung und Lieferung erfolgt durch einen beauftragten Betrieb

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): none

keine

Reason for Withdrawing:

WDA was returned on 27.02.2025.

GHE wurde am 27.2.2025 zurückgegeben.

Union Format for a Wholesale Distribution Authorisation	DE_HE_01_WDA_2024_0025
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