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RTF Template


Regierung Von Oberbayern

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products


1. Authorisation Number

:

DE_BY_04_WDA_2025/ROB-55Ph- 2678.Ph_2-63-140-4

2. Name of Authorisation Holder

:

MSD Sharp & Dohme GmbH

(ORG-100003258 / LOC-100059441)

3. Address(es) of Site(s)

:

Levelingstrasse 4a, Berg Am Laim, Munich, Bavaria, 81673, Germany 




4. Legally registered address of Authorisation Holder

:

Levelingstrasse 4a, Berg Am Laim, Munich, Bavaria, 81673

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

:

2025-06-30

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: MSD Sharp & Dohme GmbH

(ORG-100003258 / LOC-100059441)

, Levelingstrasse 4a, Berg Am Laim, Munich, Bavaria, 81673, Germany   



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 

   2.2. Holding 

   2.3. Supply 


3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

   3.3. Other products: (please specify here or make a reference to Annex 5) immunological and cold chain-required medicines




Any restrictions or clarifying remarks (for all users):  e 2.2: See Annex 2, Storage by Loxxess Pharma GmbH

The business premises are located at Levelingstr. 4a & 4c

Zu 2.2: Siehe Anlage 2, Lagerung durch Loxxess Pharma GmbH

Die Betriebsstätte befindet sich in der Levelingstr. 4a & 4c















Union Format for a Wholesale Distribution Authorisation

DE_BY_04_WDA_2025/ROB-55Ph- 2678.Ph_2-63-140-4


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