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RTF Template


Landesamt für soziale Dienste Schleswig-Holstein

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION


1. Authorisation Number

:

DE_SH_01_WDA_2018_0018

2. Name of Authorisation Holder

:

Henry Kruse GmbH & Co. Kommanditgesellschaft

3. Address(es) of Site(s)

:

Neuenbrook 6, Neumünster, 24537, Germany 

Zum Fliegerhorst 6, Sylt, 25980, Germany 

Daimlerstraße 1, Stockelsdorf, 23617, Germany 




4. Legally registered address of Authorisation Holder

:

Neuenbrook 6, Neumünster, 24537, 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

:

2018-06-25

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: Henry Kruse GmbH & Co. Kommanditgesellschaft

, Neuenbrook 6, Neumünster, 24537, Germany   




1. MEDICINAL PRODUCTS

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


2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

   2.1. Procurement 

   2.2. Holding 

   2.3. Supply 



Any restrictions or clarifying remarks (for all users):  National legal basis of authorisation: Section 52a (1) German Drug Law (Arzneimittelgesetz - AMG).


Name and address of the site: Henry Kruse GmbH & Co. Kommanditgesellschaft, Zweigniederlassung Sylt

, Zum Fliegerhorst 6, Sylt, 25980, Germany   




1. MEDICINAL PRODUCTS

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


2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

   2.1. Procurement 

   2.2. Holding 

   2.3. Supply 



Any restrictions or clarifying remarks (for all users):  National legal basis of authorisation: Section 52a (1) German Drug Law (Arzneimittelgesetz - AMG).

1.1 Site Henry Kruse GmbH & Co. Kommanditgesellschaft, Zweigniederlassung Sylt:
Exclusively hand and skin disinfectants.


Name and address of the site: Henry Kruse GmbH & Co. Kommanditgesellschaft, Zweigniederlassung Stockelsdorf

, Daimlerstraße 1, Stockelsdorf, 23617, Germany   




1. MEDICINAL PRODUCTS

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


2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

   2.1. Procurement 

   2.2. Holding 

   2.3. Supply 



Any restrictions or clarifying remarks (for all users):  National legal basis of authorisation: Section 52a (1) German Drug Law (Arzneimittelgesetz - AMG).



*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_SH_01_WDA_2018_0018


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