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RTF Template


RegierRegierungspraesidium Tuebingen - Referat 25: Übrige Pharmazeutische Bereicheungspraesidium Tuebingen - Referat 25: Übrige Pharmazeutische Bereiche

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION


1. Authorisation Number

:

DE_BW_05_WDA_2017_0007

2. Name of Authorisation Holder

:

Radecker Notfallmedizin

3. Address(es) of Site(s)

:

Zeppelinstraße 21, Ammerbuch / Entringen, 72119, Germany 




4. Legally registered address of Authorisation Holder

:

Zeppelinstraße 21, Ammerbuch / Entringen, 72119, 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

:

2017-11-13

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: Radecker Notfallmedizin

, Zeppelinstraße 21, Ammerbuch / Entringen, 72119, 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):  the wholesale authorisation is limited to hands- and skin disinfectants, infusion solutions (glucose- and natrium chloride solution of the companies Fesenius and B. Braun) and elecrolyte solutions (Jonosteril, Sterofundin-, Ringer- and Ringer-Lactate-solutions) with volumes bigger than 500 mL; no warehousing of gas for medicinal use in compressed pressure gas cylinders.

die Erlaubnis sit beschränkt auf Haut- und Händedesinfektionsmittel, Infusionslösungen (Glucose- und Kochsalzinfusionslösungen von Fresenius und B. Braun) sowie Elektrolytlösungen (Jonosteril, Sterofundin-, Ringer- und Ringer-Lactat-Lösungen) ab einem Volumen von 500 mL; keine Lagerhaltung medizinischer Gase in Druckgasbehältnissen.



*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_05_WDA_2017_0007


Page 1





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