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RTF Template

State Office of Health and Social Affairs Berlin

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Veterinary medicinal products

1. Authorisation Number	:	5373/2-TVM Tiergesundheit/01
2. Name of Authorisation Holder	:	Tvm Tiergesundheit GmbH (ORG-100039321 / LOC-100061895)
3. Address(es) of Site(s)	:	Reuchlinstrasse 10-11, Moabit, Berlin, 10553, Germany

4. Legally registered address of Authorisation Holder	:	Reuchlinstrasse 10-11, Moabit, Berlin, 10553
5. Scope of authorisation (complete for each site under 4)	:	ANNEX 1
6. Legal basis of authorisation	:	§52a Absatz 1 des Gesetzes über den Verkehr mit Arzneimitteln (Arzneimittelgesetz - AMG) in gültiger Fassung
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2021-09-29
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: Tvm Tiergesundheit GmbH

(ORG-100039321 / LOC-100061895)

, Reuchlinstrasse 10-11, Moabit, Berlin, 10553, 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

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.1. Narcotic or psychotropic products

Any restrictions or clarifying remarks (for all users): Re 1.1: Exclusively wholesale of veterinary medicinal products for which TVM Tiergesundheit GmbH is co-distributor.
Within the scope of wholesale trade, no physical handling of pharmaceuticals takes place at the premises.

Zu 1.1: Ausschließlich Großhandel mit Tierarzneimitteln, für die die TVM Tiergesundheit GmbH Mitvertreiberin ist.
Im Rahmen des Großhandels erfolgt kein physischer Umgang mit Arzneimitteln in der Betriebsstätte.

*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	5373/2-TVM Tiergesundheit/01
	Page 1

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