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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_2022_0002
2. Name of Authorisation Holder	:	GALENpharma GmbH (ORG-100000416 / LOC-100004825)
3. Address(es) of Site(s)	:	Wittland 13, Hasseldieksdamm, Kiel, Schleswig-Holstein, 24109, Germany

4. Legally registered address of Authorisation Holder	:	Wittland 13, Hasseldieksdamm, Kiel, Schleswig-Holstein, 24109, Germany
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	:	2022-02-11
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: GALENpharma GmbH

(ORG-100000416 / LOC-100004825)

, Wittland 13, Hasseldieksdamm, Kiel, Schleswig-Holstein, 24109, Germany

Human medicinal products

1. MEDICINAL PRODUCTS

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

1.3. without a Marketing Authorisation or registration in the EEA and intended for exportation

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.3. Supply

2.4. Export

Any restrictions or clarifying remarks (for all users): The medicines are stored on behalf of the company: Next Pharma Logistics GmbH, 33605 Bielefeld, at the premises: Eichenbusch 1, 59368 Werne.

Die Lagerung der Arzneimittel erfolgt im Auftrag durch die Firma: Next Pharma Logistics GmbH, 33605 Bielefeld, in der Betriebsstätte: Eichenbusch 1, 59368 Werne.

Union Format for a Wholesale Distribution Authorisation	DE_SH_01_WDA_2022_0002
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