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RTF Template

Landesamt Fuer Soziales Jugend Und Versorgung

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	DE_RP_01_WDA_2024_54.1/GDP/111-017
2. Name of Authorisation Holder	:	Adrexpharma GmbH (ORG-100033327 / LOC-100073827)
3. Address(es) of Site(s)	:	Jakob-Hasslacher-Strasse 4, Bubenheim, Koblenz, Rhineland-Palatinate, 56070, Germany

4. Legally registered address of Authorisation Holder	:	Jakob-Hasslacher-Strasse 4, Bubenheim, Koblenz, Rhineland-Palatinate, 56070
5. Scope of authorisation (complete for each site under 4)	:	ANNEX 1
6. Legal basis of authorisation	:	Art. 77(1) of Directive 2001/83/EC
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2024-06-27
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: Adrexpharma GmbH

(ORG-100033327 / LOC-100073827)

, Jakob-Hasslacher-Strasse 4, Bubenheim, Koblenz, Rhineland-Palatinate, 56070, Germany

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

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.1. Narcotic or psychotropic products

Any restrictions or clarifying remarks (for all users): Wholesale activities are restricted to the distribution of the following products:
- Cannabis Flos
- Cannabis Extract, standardized

-------------------------------------------------------------------------------------------
Restrictions or remarks (in National Language) :
Die Großhandelstätigkeiten sind beschränkt auf den Handel mit folgenden Produkten:
- Cannabis Flos
- eingestelltem Cannabisextrakt

*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	DE_RP_01_WDA_2024_54.1/GDP/111-017
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