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RTF Template

Government of Upper Bavaria - Central Authority for Supervision of Medicinal Products in Bavaria (GMP/GCP)

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Veterinary medicinal products

1. Authorisation Number	:	ROB-55Ph-2678.Ph_3-233-47-10
2. Name of Authorisation Holder	:	Piramal Critical Care Deutschland GmbH (ORG-100038325 / LOC-100060300)
3. Address(es) of Site(s)	:	Am Soeldnermoos 17, Hallbergmoos, Bavaria, 85399, Germany

4. Legally registered address of Authorisation Holder	:	Am Soeldnermoos 17, Hallbergmoos, Bavaria, 85399
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	:	2022-08-24
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: Piramal Critical Care Deutschland GmbH

(ORG-100038325 / LOC-100060300)

, Am Soeldnermoos 17, Hallbergmoos, Bavaria, 85399, Germany

Veterinary medicinal products

1. MEDICINAL PRODUCTS

1.1. with a Marketing Authorisation in EEA country(s)

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.1. Narcotic or psychotropic products

*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	ROB-55Ph-2678.Ph_3-233-47-10
	Page 1

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