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RTF Template


Regierungspraesidium Tuebingen, Leitstelle Arzneimittelueberwachung Baden-Wuerttemberg

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION


1. Authorisation Number

:

DE_BW_01_WDA_2018_0001_Klocke_Verpackung

2. Name of Authorisation Holder

:

Klocke Verpackungs-Service GmbH

3. Address(es) of Site(s)

:

Max-Becker-Str. 6, Weingarten, Baden-Wuerttemberg, 76356, Germany 

Werner-Siemens-Str. 9, Weingarten, 76356, Germany 




4. Legally registered address of Authorisation Holder

:

Max-Becker-Str. 6, Weingarten, Baden-Wuerttemberg, 76356, 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

:

2018-11-08

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: Klocke Verpackungs-Service

, Max-Becker-Str. 6, Weingarten, Baden-Wuerttemberg, 76356, Germany   




1. MEDICINAL PRODUCTS

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

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

   2.1. Procurement 

   2.2. Holding 

   2.3. Supply 

   2.4. Export 


3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

     3.1.1. Narcotic or psychotropic products 




Any restrictions or clarifying remarks (for all users):  Also veterinary medicines.

Auch Tierarzneimittel.


Name and address of the site: Klocke Verpackungs-Service

, Werner-Siemens-Str. 9, Weingarten, 76356, Germany   




1. MEDICINAL PRODUCTS

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

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

   2.2. Holding 


3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

     3.1.1. Narcotic or psychotropic products 




Any restrictions or clarifying remarks (for all users):  Also veterinary medicines.

Auch Tierarzneimittel.



*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_BW_01_WDA_2018_0001_Klocke_Verpackung


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