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Information Messages

The WDA has been withdrawn, withdrawn date is: 2024-11-07

RTF Template

Swedish Medical Products Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	5.9.4-2024-018947
2. Name of Authorisation Holder	:	Fresenius Kabi AB (ORG-100001206 / LOC-100061982)
3. Address(es) of Site(s)	:	Kraftvagen 1, Kungsangen, 196 37, Sweden

4. Legally registered address of Authorisation Holder	:	-, Uppsala, 751 74
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	:	2024-03-01
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: Fresenius Kabi AB

(ORG-100001206 / LOC-100007978)

, Kraftvagen 1, Kungsangen, 196 37, Sweden

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

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): Wholesale activities shall take place in building B5 and B13, Kraftvägen 1, Kungsängen, as well as the marketing company at Bredgränd 14 in Uppsala.

*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

Reason for Withdrawing:

Replaced by authorisation number 5.9.4-2024-015109 dated 2024-11-08.

Union Format for a Wholesale Distribution Authorisation	5.9.4-2024-018947
	Page 1

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