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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_2024_5373/1-Vayamed/06
2. Name of Authorisation Holder	:	Vayamed GmbH (ORG-100034409 / LOC-100054532)
3. Address(es) of Site(s)	:	Jaegerstrasse 28-31, Mitte, Berlin, 10117, Germany

4. Legally registered address of Authorisation Holder	:	Jaegerstrasse 28-31, Mitte, Berlin, 10117
5. Scope of authorisation (complete for each site under 4)	:	ANNEX 1
6. Legal basis of authorisation	:	§ 52a (1) Arzneimittelgesetz (german drug law)
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2024-05-21
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: Vayamed GmbH

(ORG-100034409 / LOC-100054532)

, Jaegerstrasse 28-31, Mitte, Berlin, 10117, 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 contracted companyExterne 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): According to the floor plan dated 2024-05-13
Ref. 1.1: Exclusively wholesale of medicinal cannabis flowers as bulk, cannabis extracts as bulk and dronabinol solution.
There is no physical handling of medicinal products on the site.

Gemäß dem Grundrissplan mit Datum vom 13.05.2024
Zu 1.1: Ausschließlich Großhandel mit Medizinal-Cannabisblüten als Bulk, Cannabisextrakten als Bulk und Dronabinollösung.
In der Betriebsstätte erfolgt kein physischer Umgang mit Arzneimitteln.

*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_2024_5373/1-Vayamed/06
	Page 1

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