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RTF Template


Landesamt Fuer Gesundheit Und Soziales

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products


1. Authorisation Number

:

DE_BE_01_WDA_2023_5373/1 - Greenstein Germany GmbH/04

2. Name of Authorisation Holder

:

Greenstein Germany GmbH

(ORG-100033217 / LOC-100081015)

3. Address(es) of Site(s)

:

Gipsstrasse 5, Mitte, Berlin, 10119, Germany 




4. Legally registered address of Authorisation Holder

:

Gipsstrasse 5, Mitte, Berlin, 10119

5. Scope of authorisation

:

ANNEX 1

6. Legal basis of authorisation

:

§ 52a (1) Arzneimittelgesetz AMG (German Medicinal Products Act))

7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation

:

Confidential, Confidential

8. Signature

:


9. Date

:

2023-08-15

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: Greenstein Germany GmbH

(ORG-100033217 / LOC-100081015)

, Gipsstrasse 5, Mitte, Berlin, 10119, 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 

   2.5. Other activities(s): external storage in contracted facilitiesexterne Lagerung in beauftragten Betrieben


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 and cannabis extracts in bulk.
Re 3.1.1: Subject to a corresponding permit pursuant to Section 3 of the Narcotics Act.
No physical handling of medicinal products takes place at the premises in the context of wholesale trade.

Zu 1.1: Ausschließlich Großhandel mit Medizinal-Cannabisblüten und Cannabisextrakten als Bulk.
Zu 3.1.1: Vorbehaltlich einer entsprechenden Erlaubnis nach § 3 Betäubungsmittelgesetz.
In der Betriebsstätte erfolgt kein physischer Umgang mit Arzneimitteln im Rahmen des Großhandels.















Union Format for a Wholesale Distribution Authorisation

DE_BE_01_WDA_2023_5373/1 - Greenstein Germany GmbH/04


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