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RTF Template


Department of drug and pharmacy supervision

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION


1. Authorisation Number

:

DE_ST_01_WDA_2018_014

2. Name of Authorisation Holder

:

Halle Sanitätshaus GmbH

3. Address(es) of Site(s)

:

Neustädter Passage 9, Halle (Saale), 06122, Germany 




4. Legally registered address of Authorisation Holder

:

Neustädter Passage 9, Halle (Saale), 06122, 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

:

2018-06-14

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: Halle Sanitätshaus GmbH

, Neustädter Passage 9, Halle (Saale), 06122, 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 trade is carried out in the premises according to the present site plans from 01.12.2005.
Only skin and hand disinfectants and medical oxygen are given to physicians and other consumers.

Der Großhandel wird in den Räumen gemäß der vorliegenden Lagepläne vom 01.12.2005 durchgeführt.
Es werden ausschließlich Haut- und Händedesinfektionsmittel sowie medizinischer Sauerstoff an Ärzte und andere Verbraucher abgegeben.



*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_ST_01_WDA_2018_014


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