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RTF Template

Regierung Von Oberfranken

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Veterinary medicinal products

1. Authorisation Number	:	ROF-SG55.2-2675.3-74-7-6
2. Name of Authorisation Holder	:	Baxter Deutschland GmbH (ORG-100003406 / LOC-100001033)
3. Address(es) of Site(s)	:	Am Aischpark 9, Hoechstadt A.D.Aisch, 91315, Germany

4. Legally registered address of Authorisation Holder	:	Edisonstrasse 4, Lohhof, Unterschleissheim, Bavaria, 85716
5. Scope of authorisation (complete for each site under 4)	:	ANNEX 1
6. Legal basis of authorisation	:	Art. 99 of Regulation (EU) 2019/6
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2023-08-24
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 Deutschland GmbH

(ORG-100003406 / LOC-100062937)

, Am Aischpark 9, Hoechstadt A.D.Aisch, 91315, Germany

Veterinary 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

Any restrictions or clarifying remarks (for all users): Wholesale of Isoflurane ISOFLURANE VET 250ML GER-MANY product code HDG9623V only.

ausschließlich Großhandel mit dem Produkt Isofluran ISOFLURANE VET 250ML GER-MANY, Produktcode HDG9623V

*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	ROF-SG55.2-2675.3-74-7-6
	Page 1

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