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RTF Template


Landesdirektion Sachsen

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION


1. Authorisation Number

:

DE_SN_01/L24-5117/127

2. Name of Authorisation Holder

:

Torsten Bartzsch

3. Address(es) of Site(s)

:

Aussiger Straße 6, Dresden, 01277, Germany 




4. Legally registered address of Authorisation Holder

:

Aussiger Straße 6, Dresden, 01277, 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

:

2016-03-16

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: Medizinischer Bedarf T. Bartzsch

, Aussiger Straße 6, Dresden, 01277, 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 


3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

   3.2. Medicinal gases 




Any restrictions or clarifying remarks (for all users):  This authorisation is limited to infusion solutions in containers of at least 500 ml, disinfectants and medicinal gases which do not need to be stored under "cool", "cold" or "freezer" conditions.

Diese Erlaubnis gilt nur für den Großhandel mit Infusionslösungen ab 500 ml, Desinfektionsmitteln und medizinischen Gasen, die nicht kühl oder tiefgekühlt zu lagern sind.



*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_SN_01/L24-5117/127


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