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RTF Template


Austrian Agency For Health And Food Safety

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products


1. Authorisation Number

:

480501

2. Name of Authorisation Holder

:

Gruenenthal Oesterreich GmbH

(ORG-100000517 / LOC-100088790)

3. Address(es) of Site(s)

:

Mariahilfer Strasse 123/341, Mariahilf, Vienna, 1060, Austria 




4. Legally registered address of Authorisation Holder

:

Mariahilfer Strasse 123/341, Mariahilf, Vienna, 1060

5. Scope of authorisation

:

ANNEX 1

6. Legal basis of authorisation

:

Art. 77(1) of Directive 2001/83/EC

7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation

:

Confidential, Confidential

8. Signature

:


9. Date

:

2003-07-17

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: Gruenenthal Oesterreich GmbH

(ORG-100000517 / LOC-100088790)

, Mariahilfer Strasse 123/341, Mariahilf, Vienna, 1060, Austria   



Human medicinal products


1. MEDICINAL PRODUCTS

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


2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

   2.1. Procurement 

   2.3. Supply 


3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

   3.1. Narcotic or psychotropic products** 




Any restrictions or clarifying remarks (for all users):  Grünenthal Österreich GmbH; Eingeschränkt auf den Bürobetrieb / Restricted to office operations

Grünenthal Österreich GmbH; Eingeschränkt auf den Bürobetrieb / Restricted to office operations



**Without prejudice to further authorisations as may be required according to national legislation.













Union Format for a Wholesale Distribution Authorisation

480501


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