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RTF Template

State Office of Health and Social Affairs Berlin

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	5384/11- Montu Therapeutics GmbH/01
2. Name of Authorisation Holder	:	Montu Therapeutics GmbH
3. Address(es) of Site(s)	:	Schaper Str. 18, Berlin, 10719, Germany

4. Legally registered address of Authorisation Holder	:	Schaper Str. 18, Berlin, 10719, Germany
5. Scope of authorisation	:	ANNEX 1
6. Legal basis of authorisation	:
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2021-02-24
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: Montu Therapeutics GmbH

, Schaper Str. 18, Berlin, 10719, Germany

1. MEDICINAL PRODUCTS

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

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): 1.1: Exclusively wholesale of medicinal cannabis flowers as bulk.
3.1.1: Subject to a corresponding permit according to § 3 German Narcotics Act.
There is no physical handling of medicinal products on the site.

zu 1.1 Ausschließlich Großhandel mit Medizinal Cannabisblüten als Bulk.
Zu 3.1.1 Vorbehaltlich einer entsprechenden Erlaubnis nach § 3 Betäubungsmittelgesetz. In der Betriebsstätte erfolgt kein physischer Umgang mit Arzneimitteln.

Union Format for a Wholesale Distribution Authorisation	5384/11- Montu Therapeutics GmbH/01
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