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Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-04-01

RTF Template

Norwegian Medical Products Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	24/24850-2
2. Name of Authorisation Holder	:	Baxter AS (ORG-100004677 / LOC-100061911)
3. Address(es) of Site(s)	:	Nydalsveien 33, Oslo, 0484, Norway

4. Legally registered address of Authorisation Holder	:	Nydalsveien 33, Oslo, 0484, Norway
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	:	2025-01-01
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: Baxter AS

(ORG-100004677 / LOC-100061911)

, Nydalsveien 33, Oslo, 0484, Norway

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

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2.1. Temperatures between 2 to 8 °C

3.3. Other products: (please specify here or make a reference to Annex 5) Medicinal products derived from blood, immunological medicinal products

Any restrictions or clarifying remarks (for all users): The WDA replaces the former WDA number 23/12817-3 of the company BAXTER HEALTHCARE SA from 1 january 2025.

Reason for Withdrawing:

Replaced by updated version.

Union Format for a Wholesale Distribution Authorisation	24/24850-2
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