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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 - Curium Germany GmbH/03

2. Name of Authorisation Holder

:

Curium Germany GmbH

(ORG-100004619 / LOC-100005201)

3. Address(es) of Site(s)

:

Alt-Moabit 91 D, Tiergarten, Berlin, 10559, Germany 




4. Legally registered address of Authorisation Holder

:

Alt-Moabit 91 D, Tiergarten, Berlin, 10559

5. Scope of authorisation (complete for each site under 4)

:

ANNEX 1

6. Legal basis of authorisation

:

§ 52a (1) Arzneimittelgesetz (Medicinal Products Act)

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

:

Confidential, Confidential

8. Signature

:


9. Date

:

2023-05-10

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: Curium Germany GmbH

(ORG-100004619 / LOC-100005201)

, Alt-Moabit 91 D, Tiergarten, Berlin, 10559, 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

     3.1.3. Immunological medicinal products 

     3.1.4. Radiopharmaceuticals (including radionuclide kits) 

   3.3. Cold chain products(requiring low temperature handling) 




Any restrictions or clarifying remarks (for all users):  According to the floor plan dated 05.05.2023.

Gemäß dem Grundrissplan vom 05.05.2023.



*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_BE_01_WDA_2023_5373/1 - Curium Germany GmbH/03


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