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RTF Template

Regierungspraesidium Tuebingen, Leitstelle Arzneimittelueberwachung Baden-Wuerttemberg

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	DE_BW_01_WDA_2020_0002
2. Name of Authorisation Holder	:	Oxygen Handel GmbH
3. Address(es) of Site(s)	:	Besselstraße 25, Mannheim, 68219, Germany

4. Legally registered address of Authorisation Holder	:	Besselstraße 25, Mannheim, 68219, Germany
5. Scope of authorisation (complete for each site under 4)	:	ANNEX 1
6. Legal basis of authorisation	:
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2020-11-30
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: Oxygen Handel GmbH

, Besselstraße 25, Mannheim, 68219, Germany

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

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): ad 1.2: dried Cannabis flowers: Cannabixir Forte and Cannabixir Medium

2.2 Holding at PHOENIX Pharma-Einkauf GmbH
Niederlassung Hanau, Lippestraße 9A, 63452 Hanau

zu 1.2: Cannabisblüten: Cannabixir Forte und Cannabixir Medium

2.2 Lagerung durch PHOENIX Pharma-Einkauf GmbH
Niederlassung Hanau, Lippestraße 9A, 63452 Hanau

*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_2020_0002
	Page 1

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