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RTF Template

Regierungspraesidium Tuebingen Leitstelle Arzneimittelueberwachung Baden-Wuerttemberg

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	DE_BW_01_WDA_2024_0001_Canopy Growth
2. Name of Authorisation Holder	:	Canopy Growth Germany GmbH (ORG-100033399 / LOC-100052223)
3. Address(es) of Site(s)	:	Lanzstrasse 20, Rot, St. Leon-Rot, Baden-Wuerttemberg, 68789, Germany

4. Legally registered address of Authorisation Holder	:	Lanzstrasse 20, Rot, St. Leon-Rot, Baden-Wuerttemberg, 68789, Germany
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	:	2024-07-11
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: Canopy Growth Germany GmbH

(ORG-100033399 / LOC-100052223)

, Lanzstrasse 20, Rot, St. Leon-Rot, Baden-Wuerttemberg, 68789, Germany

Human medicinal products

1. MEDICINAL PRODUCTS

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

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

1.3. without a Marketing Authorisation in the EEA and intended for exportation

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

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): Re No 3.1.1: The authorisation was issued for the wholesale of cannabis flowers and cannabis extracts.

The permit is issued with the following conditions:
The permission only entitles to the wholesale of cannabis flowers and cannabis extracts within the scope of a license according to § 4 of the med. Cannabis act.

Zu Nr. 3.1.1: Die Erlaubnis wurde für den Großhandel mit Cannabisblüten und Cannabisextrakten erteilt.

Die Erlaubnis wird mit folgenden Nebenbestimmungen erteilt:
Die Erlaubnis berechtigt nur zum Großhandel mit Cannabisblüten und Cannabisextrakten im Rahmen einer Erlaubnis nach § 4 MedCanG.

*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_BW_01_WDA_2024_0001_Canopy Growth
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