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RTF Template

State Office of Health and Social Affairs Berlin

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	DE_BE_01_WDA_2022_5373/1/01 Avextra Pharma GmbH/04
2. Name of Authorisation Holder	:	Avextra Pharma GmbH (ORG-100035937 / LOC-100056889)
3. Address(es) of Site(s)	:	Kurfuerstendamm 195, Charlottenburg, Berlin, 10707, Germany

4. Legally registered address of Authorisation Holder	:	Kurfuerstendamm 195, Charlottenburg, Berlin, 10707
5. Scope of authorisation (complete for each site under 4)	:	ANNEX 1
6. Legal basis of authorisation	:	§ 52a Abs. 1 Arzneimittelgesetz
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2022-11-16
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: Avextra Pharma GmbH

(ORG-100035937 / LOC-100056889)

, Kurfuerstendamm 195, Charlottenburg, Berlin, 10707, Germany

Human medicinal products

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.3. Supply

2.4. Export

2.5. Other activities(s): External storage in a commissioned facilityExterne Lagerung in einem beauftragten Betrieb

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.1. Narcotic or psychotropic products

Any restrictions or clarifying remarks (for all users): Re 1.1: Exclusively wholesale of medicinal cannabis flowers, cannabis extracts and dronabinol solution in bulk.
Re 3.1.1: Subject to a corresponding permit pursuant to Section 3 of the Narcotics Act.
There is no physical handling of medicinal products at the premises.

Zu 1.1: Ausschließlich Großhandel mit Medizinal-Cannabisblüten, Cannabisextrakten und Dronabinol-Lösung als Bulk.
Zu 3.1.1: Vorbehaltlich einer entsprechenden Erlaubnis nach § 3 Betäubungsmittelgesetz.
Es erfolgt kein physischer Umgang mit Arzneimitteln in der Betriebsstätte.

*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_BE_01_WDA_2022_5373/1/01 Avextra Pharma GmbH/04
	Page 1

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