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RTF Template

Government of Upper Franconia

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Veterinary medicinal products

1. Authorisation Number	:	ROF-SG55.2-2675.4-13-7-8
2. Name of Authorisation Holder	:	LABOklin Labor fuer klinische Diagnostik GmbH & Co. KG (ORG-100041752 / LOC-100068862)
3. Address(es) of Site(s)	:	Steubenstrasse 4, Bad Kissingen, Bavaria, 97688, Germany

4. Legally registered address of Authorisation Holder	:	Steubenstrasse 4, Bad Kissingen, Bavaria, 97688
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	:	2023-02-03
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: LABOklin Labor fuer klinische Diagnostik GmbH & Co. KG

(ORG-100041752 / LOC-100068862)

, Steubenstrasse 4, Bad Kissingen, Bavaria, 97688, 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

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.3. Immunological medicinal products

Any restrictions or clarifying remarks (for all users): Trade in auto-vaccines and hyposensitization solutions/ASIT (allergen-specific immunotherapeutics)

Handel mit Autovakzinen sowie Hyposensibilisierungs-Lösungen/ASIT (Allergen-spezifische Immuntherapeutika)

*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-SG55.2-2675.4-13-7-8
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