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RTF Template


Landesamt Fuer Soziale Dienste Schleswig Holstein

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products


1. Authorisation Number

:

DE_SH_01_WDA_2023_0010

2. Name of Authorisation Holder

:

Marmed GmbH & Co. KG

(ORG-100034744 / LOC-100055116)

3. Address(es) of Site(s)

:

Assenkoppeln 3 und 3A, Fockbek, 24787, Germany 




4. Legally registered address of Authorisation Holder

:

Assenkoppeln 3, Fockbek, Schleswig-Holstein, 24787

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

:

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 wholesaling authorisation

:

Confidential, Confidential

8. Signature

:


9. Date

:

2023-07-27

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: marmed GmbH & Co. KG

, Assenkoppeln 3 und 3A, Fockbek, 24787, 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 

   2.2. Holding 

   2.3. Supply 


3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

   3.2. Medicinal gases 




Any restrictions or clarifying remarks (for all users):  National legal basis of authorisation:
Section 52a (1) German Drug Law (Arzneimittelgesetz - AMG).



*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_SH_01_WDA_2023_0010


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