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RTF Template


Landesamt Fuer Gesundheit Und Soziales

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products


1. Authorisation Number

:

DE_BE_01_WDA_2023_5373/1 - Sovelio Großhandels GmbH/02

2. Name of Authorisation Holder

:

Sovelio Grosshandels GmbH

(ORG-100037979 / LOC-100059879)

3. Address(es) of Site(s)

:

Kantstrasse 103, Charlottenburg, Berlin, 10627, GERMANY 




4. Legally registered address of Authorisation Holder

:

Kantstrasse 103, Charlottenburg, Berlin, 10627

5. Scope of authorisation

:

ANNEX 1

6. Legal basis of authorisation

:

§ 52 a Abs. 1 Arzneimittelgesetz

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

:

Confidential, Confidential

8. Signature

:


9. Date

:

2023-10-18

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: Sovelio Grosshandels GmbH

(ORG-100037979 / LOC-100059879)

, Kantstrasse 103, Charlottenburg, Berlin, 10627, GERMANY   



Human medicinal products


1. MEDICINAL PRODUCTS

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


2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

   2.1. Procurement 

   2.3. Supply 


3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

     3.1.1. Narcotic or psychotropic products 

     3.1.3. Immunological medicinal products 

   3.3. Cold chain products(requiring low temperature handling) 




Any restrictions or clarifying remarks (for all users):  Re 2.1 and 2.3: Exclusively in the context of drop shipments.
Re 3.1.1: Subject to a corresponding license in accordance with Section 3 of the Narcotics Act.

Zu 2.1 und 2.3: Ausschließlich im Rahmen des Streckengeschäftes.
Zu 3.1.1: Vorbehaltlich einer entsprechenden Erlaubnis nach § 3 Betäubungsmittelgesetz.















Union Format for a Wholesale Distribution Authorisation

DE_BE_01_WDA_2023_5373/1 - Sovelio Großhandels GmbH/02


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