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RTF Template


Bezirksregierung Koeln

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products


1. Authorisation Number

:

DE_NW_04_WDA_2024-0175-01

2. Name of Authorisation Holder

:

Herbasana GmbH

(ORG-100044292 / LOC-100073234)

3. Address(es) of Site(s)

:

Ziegeleiweg 6a, Westhoven, Cologne, North Rhine-Westphalia, 51149, Germany 




4. Legally registered address of Authorisation Holder

:

Ziegeleiweg 6a, Westhoven, Cologne, North Rhine-Westphalia, 51149

5. Scope of authorisation

:

ANNEX 1

6. Legal basis of authorisation

:

Art. 77(1) of Directive 2001/83/EC

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

:

Confidential, Confidential

8. Signature

:


9. Date

:

2024-08-15

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: Herbasana GmbH

(ORG-100044292 / LOC-100073234)

, Ziegeleiweg 6a, Westhoven, Cologne, North Rhine-Westphalia, 51149, Germany   



Human medicinal products


1. MEDICINAL PRODUCTS

   1.2. without a Marketing Authorisation or registration in the EEA and intended for EEA market*


2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

   2.1. Procurement 

   2.3. Supply 



Any restrictions or clarifying remarks (for all users):  To 1.2 cannabis flowers only
To 3.1.1 subject to a corresponding permit according to § 4 MedCanG
Storage is external.

Zu 1.2 nur Cannabisblüten
Zu 3.1.1 vorbehaltlich einer entsprechenden Erlaubnis nach § 4 MedCanG
Die Lagerung erfolgt extern.



*Art. 5 of Directive 2001/83/EC, Art. 83 of Regulation (EC) 726/2004 and Art. 110 of Regulation 2019/6.













Union Format for a Wholesale Distribution Authorisation

DE_NW_04_WDA_2024-0175-01


Page 1





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