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RTF Template

North Rhine Westphalia State Agency For Nature Environment And Consumer Protection

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Veterinary medicinal products

1. Authorisation Number	:	65.46.34.01-000005-GHVE02
2. Name of Authorisation Holder	:	NOWEDA Arzneimittel AG (ORG-100024831 / LOC-100055224)
3. Address(es) of Site(s)	:	Schuckertstrasse 22, Berg Fidel, Muenster, North Rhine-Westphalia, 48153, GERMANY

4. Legally registered address of Authorisation Holder	:	Schuckertstrasse 22, Berg Fidel, Muenster, North Rhine-Westphalia, 48153
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	:	2023-12-01
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: NOWEDA Arzneimittel AG

(ORG-100024831 / LOC-100055224)

, Schuckertstrasse 22, Berg Fidel, Muenster, North Rhine-Westphalia, 48153, 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

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): Veterinary medicinal products pursuant to Article 34(1) of Regulation (EU) 2019/6
- Veterinary medicinal products containing narcotic or psychotropic substances
- Medicinal products for food-producing animals
- antimicrobial veterinary medicinal products

The permit is granted for the premises according to the room plan of 05/2023.

Tierarzneimittel entsprechend Art. 34 Abs. 1 der Verordnung (EU) 2019/6
- Suchtstoffe oder psychotrope Stoffe enthaltende Tierarzneimittel
- Arzneimittel für der Lebensmittelgewinnung dienende Tiere
- antimikrobiell wirksame Tierarzneimittel

Die Erlaubnis wird für die Räumlichkeiten gemäß Raumplan von 05/2023 erteilt.

*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	65.46.34.01-000005-GHVE02
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