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RTF Template


Government of Upper Franconia

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION


1. Authorisation Number

:

ROF-SG55.2-2675.4-71-2-5

2. Name of Authorisation Holder

:

Heinrich Klenk GmbH & Co. KG

3. Address(es) of Site(s)

:

Aschenhof 35, Schwebheim, Bayern, 97525, Germany 




4. Legally registered address of Authorisation Holder

:

Aschenhof 35, Schwebheim, Bayern, 97525, 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

:

2019-11-11

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: Heinrich Klenk GmbH & Co. KG

, Aschenhof 35, Schwebheim, Bayern, 97525, Germany   




1. MEDICINAL PRODUCTS

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


2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

   2.5. Other activities(s): drop shipment onlynur Streckengeschäft



Any restrictions or clarifying remarks (for all users):  Drop shipment of cannabis flowers of the varieties Klenk Sorte 18/1, 21/1 and 9/9 as prescription medicinal products as well as cannabis extract Klenk 5/1 as prescription medicinal products ; procurement, storage and delivery by the company Aurora Deutschland GmbH, Rudower Chaussee 29, 12469 Berlin; production of the medicinal products by the company Aurora Cannabis Enterprises Inc., 4439 TWP Road 304 TOM, ORO Cremona/Alberta, Canada

Streckengeschäfte mit Cannabisblüten der Sorten Klenk Sorte 18/1, 21/1 und 9/9 als Rezepturarzneimittel sowie mit Cannabis Extrakt Klenk 5/1 als Rezepturarzneimittel ; Beschaffung, Lagerung und Auslieferung durch die Firma Aurora Deutschland GmbH, Rudower Chaussee 29, 12469 Berlin; Herstellung der Arzneimittel durch die Firma Aurora Cannabis Enterprises Inc., 4439 TWP Road 304 TOM, ORO Cremona/Alberta, Kanada



*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

ROF-SG55.2-2675.4-71-2-5


Page 1





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