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RTF Template

Bezirksregierung Duesseldorf

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	DE_NW_03_WDA_2024_0003/24.05.05.01-iuvo
2. Name of Authorisation Holder	:	iuvo Therapeutics GmbH (ORG-100033236 / LOC-100051867)
3. Address(es) of Site(s)	:	Oststrasse 154, Stadtmitte, Duesseldorf, North Rhine-Westphalia, 40210

4. Legally registered address of Authorisation Holder	:	Oststrasse 154, Stadtmitte, Duesseldorf, North Rhine-Westphalia, 40210
5. Scope of authorisation	:	ANNEX 1
6. Legal basis of authorisation	:	Art. 77(1) of Directive 2001/83/EC § 52a AMG
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2024-02-15
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: iuvo Therapeutics GmbH

(ORG-100033236 / LOC-100051867)

, Oststrasse 154, Stadtmitte, Duesseldorf, North Rhine-Westphalia, 40210

Human medicinal products

1. MEDICINAL PRODUCTS

1.2. without a Marketing Authorisation in the EEA and intended for EEA market

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): Restrictions or clarifications regarding the scope of the licence:
The licence expressly does NOT include storage at the above-mentioned premises.
Re 1.2:
Cannabis flowers and extracts from EU/EEA countries.
Re 3.1.1:
Subject to a corresponding licence in accordance with Section 3 BtMG.

ANNEX 2
Address(es) and licence number(s) of the authorised wholesaler(s) Med-X-Press GmbH
Alte Heerstr. 9
38644 Goslar

Einschränkungen oder Klarstellungen bezüglich des Umfangs der Erlaubnis:
Die Erlaubnis umfasst ausdrücklich NICHT die Lagerung in der o.g. Betriebsstätte.
Zu 1.2:
Cannabisblüten und -extrakte aus EU/EWR-Staaten.
Zu 3.1.1:
Vorbehaltlich einer entsprechenden Erlaubnis nach § 3 BtMG.

ANLAGE 2
Anschrift/en und Erlaubnisnummer/n der Betriebsstätte/n beauftragter Großhändler Med-X-Press GmbH
Alte Heerstr. 9
38644 Goslar

Union Format for a Wholesale Distribution Authorisation	DE_NW_03_WDA_2024_0003/24.05.05.01-iuvo
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